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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023600-27 | EudraCT Number |
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fp MDPI 12.5 mcg | Experimental | Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Fp MDPI 25 mcg | Experimental | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Fp MDPI 50 mcg | Experimental | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Fp MDPI 100 mcg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fp MDPI | Drug | Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period | Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. |
Inclusion Criteria:
Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects.
Reversibility of Disease: Demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen.
Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.
Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of
Non-childbearing potential, defined as:
Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:
Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc).
Exclusion Criteria:
History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit.
Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular non-corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular non-corticosteroid maintenance treatment, or the addition of other asthma medications.
Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:
History of a positive test for HIV, hepatitis B or hepatitis C infection.
Clinical visual evidence of oral candidiasis at the Screening Visit.
History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
History of severe allergy to milk protein.
Use of systemic, oral or depot corticosteroids within 12 weeks prior to the Screening Visit
Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted.
Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit.
History of alcohol or drug abuse within two years preceding the Screening Visit.
Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
Study participation by clinical investigator site employees and/or their immediate relatives.
Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teva Investigational Site 10165 | Homewood | Alabama | United States | |||
| Teva Investigational Site 11142 |
909 subjects at 188 centers met entry criteria and were considered to be eligible for enrollment into the run-in period of the study.
A total of 1903 subjects with asthma were screened for enrollment into this study. Of the 994 subjects who were not enrolled, 983 were excluded on the basis of inclusion/exclusion criteria and 6 subjects withdrew consent, and for 5 the reason given was "other".
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo MDPI (Run-In) | Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days). |
| FG001 | Fp MDPI 12.5 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Assignment Period (Run-In Placebo) |
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Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Placebo MDPI | Experimental | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Flovent Diskus 100mcg | Experimental | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Flovent Diskus | Drug | Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms. |
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| albuterol/salbutamol | Drug | A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication). |
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| Placebo MDPI | Drug | Placebo multidose dry powder inhaler in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI. |
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| Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period | The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device. Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean. | Baseline (Days -7 to -1), During Study (Days 1-84) |
| Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12 | The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF. | Day 1 to Day 84 |
| Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
| Time of Maximum Concentration (Tmax) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
| Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. | Day 1 -84 |
| Oropharyngeal Exam Findings at Each Study Visit | Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study. Data format: Time frame, <signs of oral candidiasis?> yes or no | Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12 |
| Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose) |
| Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| Goodyear |
| Arizona |
| United States |
| Teva Investigational Site 10104 | Scottsdale | Arizona | United States |
| Teva Investigational Site 11149 | Little Rock | Arkansas | United States |
| Teva Investigational Site 10173 | Bakersfield | California | United States |
| Teva Investigational Site 10163 | Costa Mesa | California | United States |
| Teva Investigational Site 10156 | Encinitas | California | United States |
| Teva Investigational Site 11101 | Fountain Valley | California | United States |
| Teva Investigational Site 11111 | Fresno | California | United States |
| Teva Investigational Site 10151 | Granada Hills | California | United States |
| Teva Investigational Site 10157 | Huntington Beach | California | United States |
| Teva Investigational Site 10176 | Huntington Beach | California | United States |
| Teva Investigational Site 10147 | Long Beach | California | United States |
| Teva Investigational Site 11110 | Napa | California | United States |
| Teva Investigational Site 10136 | Newport Beach | California | United States |
| Teva Investigational Site 11122 | North Hollywood | California | United States |
| Teva Investigational Site 10140 | Orange | California | United States |
| Teva Investigational Site 10197 | Palmdale | California | United States |
| Teva Investigational Site 10185 | Redwood City | California | United States |
| Teva Investigational Site 10143 | Riverside | California | United States |
| Teva Investigational Site 11137 | Roseville | California | United States |
| Teva Investigational Site 10130 | San Diego | California | United States |
| Teva Investigational Site 10182 | San Diego | California | United States |
| Teva Investigational Site 10179 | San Jose | California | United States |
| Teva Investigational Site 10106 | Stockton | California | United States |
| Teva Investigational Site 10129 | Walnut Creek | California | United States |
| Teva Investigational Site 10145 | Centennial | Colorado | United States |
| Teva Investigational Site 10172 | Colorado Springs | Colorado | United States |
| Teva Investigational Site 10133 | Denver | Colorado | United States |
| Teva Investigational Site 10154 | Denver | Colorado | United States |
| Teva Investigational Site 11146 | Denver | Colorado | United States |
| Teva Investigational Site 10128 | Wheat Ridge | Colorado | United States |
| Teva Investigational Site 10196 | Waterbury | Connecticut | United States |
| Teva Investigational Site 10191 | Boynton Beach | Florida | United States |
| Teva Investigational Site 11127 | Brandon | Florida | United States |
| Teva Investigational Site 11118 | Clearwater | Florida | United States |
| Teva Investigational Site 11141 | Hialeah | Florida | United States |
| Teva Investigational Site 11140 | Kissimmee | Florida | United States |
| Teva Investigational Site 10137 | Miami | Florida | United States |
| Teva Investigational Site 10153 | Miami | Florida | United States |
| Teva Investigational Site 11120 | Miami | Florida | United States |
| Teva Investigational Site 11128 | Miami | Florida | United States |
| Teva Investigational Site 11132 | Miami | Florida | United States |
| Teva Investigational Site 11145 | Miami | Florida | United States |
| Teva Investigational Site 10171 | Ocala | Florida | United States |
| Teva Investigational Site 10178 | Sarasota | Florida | United States |
| Teva Investigational Site 11103 | South Miami | Florida | United States |
| Teva Investigational Site 10161 | Tallahassee | Florida | United States |
| Teva Investigational Site 10139 | Tampa | Florida | United States |
| Teva Investigational Site 11114 | Albany | Georgia | United States |
| Teva Investigational Site 10111 | Columbus | Georgia | United States |
| Teva Investigational Site 11124 | Columbus | Georgia | United States |
| Teva Investigational Site 10180 | Gainesville | Georgia | United States |
| Teva Investigational Site 10168 | Lawrenceville | Georgia | United States |
| Teva Investigational Site 11109 | Idaho Falls | Idaho | United States |
| Teva Investigational Site 10116 | Meridian | Idaho | United States |
| Teva Investigational Site 10127 | South Bend | Indiana | United States |
| Teva Investigational Site 10184 | Iowa City | Iowa | United States |
| Teva Investigational Site 10113 | Metairie | Louisiana | United States |
| Teva Investigational Site 10164 | Bangor | Maine | United States |
| Teva Investigational Site 10158 | Bethesda | Maryland | United States |
| Teva Investigational Site 10110 | Largo | Maryland | United States |
| Teva Investigational Site 10177 | Wheaton | Maryland | United States |
| Teva Investigational Site 10138 | North Dartmouth | Massachusetts | United States |
| Teva Investigational Site 10146 | North Dartmouth | Massachusetts | United States |
| Teva Investigational Site 10131 | Minneapolis | Minnesota | United States |
| Teva Investigational Site 10175 | St Louis | Missouri | United States |
| Teva Investigational Site 10189 | St Louis | Missouri | United States |
| Teva Investigational Site 11147 | St Louis | Missouri | United States |
| Teva Investigational Site 10118 | Bellevue | Nebraska | United States |
| Teva Investigational Site 10150 | Omaha | Nebraska | United States |
| Teva Investigational Site 11144 | Omaha | Nebraska | United States |
| Teva Investigational Site 11136 | Henderson | Nevada | United States |
| Teva Investigational Site 10114 | Brick | New Jersey | United States |
| Teva Investigational Site 10193 | Cherry Hill | New Jersey | United States |
| Teva Investigational Site 10101 | Hillsborough | New Jersey | United States |
| Teva Investigational Site 10155 | Skillman | New Jersey | United States |
| Teva Investigational Site 10188 | West Orange | New Jersey | United States |
| Teva Investigational Site 11113 | Albuquerque | New Mexico | United States |
| Teva Investigational Site 10187 | Brooklyn | New York | United States |
| Teva Investigational Site 10120 | New York | New York | United States |
| Teva Investigational Site 10190 | Newburgh | New York | United States |
| Teva Investigational Site 10167 | North Syracuse | New York | United States |
| Teva Investigational Site 10112 | Rochester | New York | United States |
| Teva Investigational Site 10105 | High Point | North Carolina | United States |
| Teva Investigational Site 10122 | Raleigh | North Carolina | United States |
| Teva Investigational Site 10194 | Canton | Ohio | United States |
| Teva Investigational Site 10107 | Cincinnati | Ohio | United States |
| Teva Investigational Site 10123 | Cincinnati | Ohio | United States |
| Teva Investigational Site 10144 | Columbus | Ohio | United States |
| Teva Investigational Site 11135 | Dayton | Ohio | United States |
| Teva Investigational Site 11115 | Middleburg Heights | Ohio | United States |
| Teva Investigational Site 10160 | Oklahoma City | Oklahoma | United States |
| Teva Investigational Site 10174 | Oklahoma City | Oklahoma | United States |
| Teva Investigational Site 10198 | Oklahoma City | Oklahoma | United States |
| Teva Investigational Site 11108 | Ashland | Oregon | United States |
| Teva Investigational Site 10132 | Eugene | Oregon | United States |
| Teva Investigational Site 10135 | Medford | Oregon | United States |
| Teva Investigational Site 10142 | Portland | Oregon | United States |
| Teva Investigational Site 11104 | Normal Square | Pennsylvania | United States |
| Teva Investigational Site 10183 | Philadelphia | Pennsylvania | United States |
| Teva Investigational Site 10166 | Pittsburgh | Pennsylvania | United States |
| Teva Investigational Site 10121 | Upland | Pennsylvania | United States |
| Teva Investigational Site 11119 | East Providence | Rhode Island | United States |
| Teva Investigational Site 10181 | Lincoln | Rhode Island | United States |
| Teva Investigational Site 10162 | Providence | Rhode Island | United States |
| Teva Investigational Site 10126 | Charleston | South Carolina | United States |
| Teva Investigational Site 10149 | Charleston | South Carolina | United States |
| Teva Investigational Site 10199 | Orangeburg | South Carolina | United States |
| Teva Investigational Site 11131 | Spartanburg | South Carolina | United States |
| Teva Investigational Site 10119 | Boerne | Texas | United States |
| Teva Investigational Site 10141 | Dallas | Texas | United States |
| Teva Investigational Site 10192 | Dallas | Texas | United States |
| Teva Investigational Site 10148 | El Paso | Texas | United States |
| Teva Investigational Site 10115 | San Antonio | Texas | United States |
| Teva Investigational Site 11133 | San Antonio | Texas | United States |
| Teva Investigational Site 11134 | San Antonio | Texas | United States |
| Teva Investigational Site 10103 | Waco | Texas | United States |
| Teva Investigational Site 11143 | Layton | Utah | United States |
| Teva Investigational Site 10195 | Provo | Utah | United States |
| Teva Investigational Site 10134 | South Burlington | Vermont | United States |
| Teva Investigational Site 10159 | Burke | Virginia | United States |
| Teva Investigational Site 10102 | Fairfax | Virginia | United States |
| Teva Investigational Site 11105 | Manassas | Virginia | United States |
| Teva Investigational Site 10108 | Richmond | Virginia | United States |
| Teva Investigational Site 10124 | Spokane | Washington | United States |
| Teva Investigational Site 11117 | Tacoma | Washington | United States |
| Teva Investigational Site 11125 | Tacoma | Washington | United States |
| Teva Investigational Site 10170 | Greenfield | Wisconsin | United States |
| Teva Investigational Site 59107 | Burgas | Bulgaria |
| Teva Investigational Site 59103 | Lovech | Bulgaria |
| Teva Investigational Site 59106 | Pleven | Bulgaria |
| Teva Investigational Site 59104 | Rousse | Bulgaria |
| Teva Investigational Site 59101 | Sofia | Bulgaria |
| Teva Investigational Site 59102 | Sofia | Bulgaria |
| Teva Investigational Site 59105 | Sofia | Bulgaria |
| Teva Investigational Site 85105 | Split | Croatia |
| Teva Investigational Site 85102 | Zagreb | Croatia |
| Teva Investigational Site 85103 | Zagreb | Croatia |
| Teva Investigational Site 85104 | Zagreb | Croatia |
| Teva Investigational Site 36107 | Balassagyarmat | Hungary |
| Teva Investigational Site 36104 | Budapest | Hungary |
| Teva Investigational Site 36105 | Budapest | Hungary |
| Teva Investigational Site 36113 | Csoma | Hungary |
| Teva Investigational Site 36103 | Miskolc | Hungary |
| Teva Investigational Site 36108 | Mosdós | Hungary |
| Teva Investigational Site 36102 | NyÃregyháza | Hungary |
| Teva Investigational Site 36106 | Szeged | Hungary |
| Teva Investigational Site 36109 | Szeged | Hungary |
| Teva Investigational Site 36101 | Szombathely | Hungary |
| Teva Investigational Site 36111 | Tatabánya | Hungary |
| Teva Investigational Site 72111 | Ashkelon | Israel |
| Teva Investigational Site 72101 | Haifa | Israel |
| Teva Investigational Site 72102 | Jerusalem | Israel |
| Teva Investigational Site 72104 | Jerusalem | Israel |
| Teva Investigational Site 72109 | Kfar Saba | Israel |
| Teva Investigational Site 72106 | Petah Tikva | Israel |
| Teva Investigational Site 72107 | Ramat Gan | Israel |
| Teva Investigational Site 72103 | Rehovot | Israel |
| Teva Investigational Site 72108 | Tel Aviv | Israel |
| Teva Investigational Site 72110 | Tel Aviv | Israel |
| Teva Investigational Site 48107 | Bialystok | Poland |
| Teva Investigational Site 48105 | Bydgoszcz | Poland |
| Teva Investigational Site 48106 | Grodzisk Mazowiecki | Poland |
| Teva Investigational Site 48101 | Lodz | Poland |
| Teva Investigational Site 48108 | Poznan | Poland |
| Teva Investigational Site 48103 | Tarnów | Poland |
| Teva Investigational Site 48104 | Wroclaw | Poland |
| Teva Investigational Site 81101 | Belgrade | Serbia |
| Teva Investigational Site 81102 | Belgrade | Serbia |
| Teva Investigational Site 34101 | Badalona | Spain |
| Teva Investigational Site 34102 | Barcelona | Spain |
| Teva Investigational Site 34103 | Salt | Spain |
| Teva Investigational Site 80101 | Dnipropetrovsk | Ukraine |
| Teva Investigational Site 80113 | Dnipropetrovsk | Ukraine |
| Teva Investigational Site 80111 | Donetsk | Ukraine |
| Teva Investigational Site 80103 | Kharkiv | Ukraine |
| Teva Investigational Site 80117 | Kharkiv | Ukraine |
| Teva Investigational Site 80104 | Kyiv | Ukraine |
| Teva Investigational Site 80105 | Kyiv | Ukraine |
| Teva Investigational Site 80106 | Kyiv | Ukraine |
| Teva Investigational Site 80107 | Kyiv | Ukraine |
| Teva Investigational Site 80108 | Kyiv | Ukraine |
| Teva Investigational Site 80109 | Kyiv | Ukraine |
| Teva Investigational Site 80114 | Odesa | Ukraine |
| Teva Investigational Site 80118 | Ternopil | Ukraine |
| Teva Investigational Site 80112 | Vinnytsia | Ukraine |
| Teva Investigational Site 80115 | Yalta | Ukraine |
| Teva Investigational Site 80110 | Zaporizhzhia | Ukraine |
Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
| FG002 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| FG003 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| FG004 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| FG005 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| FG006 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
Intent-to-Treat Analysis set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fp MDPI 12.5 mcg | Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG001 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Forced Expiratory Volume in 1 Second (FEV1) | Mean | Standard Deviation | liters |
| |||||||||||||||
| % Predicted Expiratory Volume In 1 Second | Mean | Standard Deviation | percent predicted FEV1 |
| |||||||||||||||
| Qualifying Airway Reversibility | Patients demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2-4 inhalations of albuterol/salbutamol inhalation aerosol at the screening visit. If subjects failed to demonstrate an increase in FEV1 ≥15% then subjects were not eligible for the study; however, based on investigator judgment, they were allowed to retest once within 7 days. Reversibility values of 14.50 through 14.99% were rounded to 15%. | Mean | Standard Deviation | percentage increase in FEV1 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period | Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #11). | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #12). | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #13). | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period | The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device. Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean. | Full analysis set | Posted | Mean | Standard Error | percentage of total 24 hour periods | Baseline (Days -7 to -1), During Study (Days 1-84) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12 | The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF. | Full analysis set | Posted | Number | 95% Confidence Interval | probability | Day 1 to Day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Pharmacokinetics analysis set. Placebo samples not included in these results. | Posted | Mean | Standard Deviation | pg*hr/mL | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Pharmacokinetics analysis set. Placebo samples not included in these results. | Posted | Mean | Standard Deviation | pg/mL | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
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| Secondary | Time of Maximum Concentration (Tmax) of Fp | Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments. | Pharmacokinetics analysis set. Placebo samples not included in these results. | Posted | Mean | Standard Deviation | hours | Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period | An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. | Safety analysis set | Posted | Count of Participants | Participants | Day 1 -84 |
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| Secondary | Oropharyngeal Exam Findings at Each Study Visit | Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study. Data format: Time frame, <signs of oral candidiasis?> yes or no | Safety population | Posted | Count of Participants | Participants | Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. | Posted | Least Squares Mean | Standard Error | liters | Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data | Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed. | Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. | Posted | Least Squares Mean | Standard Error | liters/minute | Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose) |
|
Day 1 to 84
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. | 2 | 104 | 5 | 104 | ||
| EG001 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. | 2 | 103 | 8 | 103 | ||
| EG002 | Fp MDPI 12.5 mcg | Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. | 0 | 103 | 10 | 103 | ||
| EG003 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. | 0 | 104 | 7 | 104 | ||
| EG004 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. | 1 | 104 | 10 | 104 | ||
| EG005 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. | 2 | 104 | 8 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Teva Branded Pharmaceutical Products, R&D Inc. | 1-215-591-3000 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
Not provided
Not provided
| Withdrawal by Subject |
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| Physician Decision |
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| Non-compliance to study drug |
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| Protocol Violation |
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| Pregnancy |
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| Sponsor request subject to be withdrawn |
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| Lost to Follow-up |
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| Met stopping criteria |
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| Adults (18-64 years) |
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| Adults (65+ years) |
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| Male |
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| Black |
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| Asian |
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| American Indian or Alaskan Native |
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| Pacific Islander |
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| Other |
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| Not Hispanic or Latino |
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| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| Superiority or Other |
| This is the second analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level. | mixed model for repeated measures | 0.0005 | The study was considered positive if the trend test was positive and the test involving the highest Fp MDPI dose (100 mcg twice daily) indicated significantly greater time averaged FEV1 mean than placebo. | LSM difference | 0.149 | 2-Sided | 95 | 0.066 | 0.233 | Superiority or Other |
| This is the third analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level. | mixed model for repeated measures | 0.0027 | LSM difference | 0.126 | 2-Sided | 95 | 0.044 | 0.208 | Superiority or Other |
| This is the fourth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level. | mixed model for repeated measures | 0.0086 | LSM difference | 0.111 | 2-Sided | 95 | 0.028 | 0.194 | Superiority or Other |
| This is the fifth analysis in the fixed-sequence testing procedure employed to control the overall Type I error rate at the 0.05 level. | mixed model for repeated measures | 0.2227 | LSM difference | 0.052 | 2-Sided | 95 | -0.032 | 0.136 | Superiority or Other |
| OG001 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| Fp MDPI 25 mcg |
Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG001 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG001 |
| Fp MDPI 25 mcg |
Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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| OG001 | Fp MDPI 25 mcg | Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG002 | Fp MDPI 50 mcg | Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG003 | Fp MDPI 100 mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG004 | Placebo MDPI | Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
| OG005 | Flovent Diskus 100mcg | Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms. |
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