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The purpose of this study is to compare once and twice daily GW685698 in asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GW685698X | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW685698X | Drug | Inhaled Corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response. | Day 28 of the relevant treatment period (up to Study Day 112) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Long Beach | California | 90806 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22188590 | Background | Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160. | |
| 27881132 | Derived | O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112202 | Annotated Case Report Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Eligible participants (par.) at screening entered a 14-day Run-in Period. Par. were then randomized to 1 of 12 sequences: 6 had placebo and two doses of fluticasone furoate (FF), and 6 had placebo and two doses of fluticasone proprionate (FP) (allocation ratio of 7:2 [FF:FP]). 320 par. were screened and 190 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: Placebo, FF 200 µg, FF 100 µg | Participants received placebo twice daily (BID), fluticasone furoate (FF) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FF 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (28 Days) |
|
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| From the first dose of the study medication up to Week 16/Early Withdrawal |
| 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period. | Day 28 of the relevant treatment period (up to Study Day 112) |
| Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
| Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
| Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
| Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods | Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol. | From the first dose of the study medication up to Week 16/Early Withdrawal |
| Long Beach |
| California |
| 90808 |
| United States |
| GSK Investigational Site | Torrance | California | 90505 | United States |
| GSK Investigational Site | Cocoa | Florida | 32927 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20814 | United States |
| GSK Investigational Site | Columbia | Missouri | 65203 | United States |
| GSK Investigational Site | Rolla | Missouri | 65401 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Medford | Oregon | 97504 | United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Austin | Texas | 78750 | United States |
| GSK Investigational Site | Boerne | Texas | 78006 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Waco | Texas | 76712 | United States |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112202 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Sequence 2: Placebo, FF 100 µg, FF 200 µg | Participants received placebo BID, FF 100 µg inhalation powder BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG002 | Sequence 3: FF 100 µg, Placebo, FF 200 µg | Participants received FF 100 µg inhalation powder BID, placebo BID, and FF 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG003 | Sequence 4: FF 100 µg, FF 200 µg, Placebo | Participants received FF 100 µg inhalation powder BID, FF 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG004 | Sequence 5: FF 200 µg, Placebo, FF 100 µg | Participants received FF 200 µg inhalation powder OD in the evening, placebo BID, and FF 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG005 | Sequence 6: FF 200 µg, FF 100 µg, Placebo | Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG006 | Sequence 7: Placebo, FP 200 µg, FP 100 µg | Participants received placebo twice daily (BID), fluticasone propionate (FP) 200 microgram (µg) inhalation powder once daily (OD) in the evening, and FP 100 µg inhalation powder twice daily (BID) in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG007 | Sequence 8: Placebo, FP 100 µg, FP 200 µg | Participants received placebo BID, FP 100 µg inhalation powder BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG008 | Sequence 9: FP 100 µg, Placebo, FP 200 µg | Participants received FP 100 µg inhalation powder BID, placebo BID, and FP 200 µg inhalation powder OD in the evening in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG009 | Sequence 10: FP 100 µg, FP 200 µg, Placebo | Participants received FP 100 µg inhalation powder BID, FP 200 µg inhalation powder OD in the evening, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG010 | Sequence 11: FP 200 µg, Placebo, FP 100 µg | Participants received FP 200 µg inhalation powder OD in the evening, placebo BID, and FP 100 µg inhalation powder BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| FG011 | Sequence 12: FP 200 µg, FP 100 µg, Placebo | Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in Treatment Periods 1, 2, and 3, respectively. All treatments were administered via a DISKUS inhaler for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| COMPLETED |
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| NOT COMPLETED |
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|
| Washout Period 1 (14 Days) |
|
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| Treatment Period 2 (28 Days) |
|
|
| Washout Period 2 (14 Days) |
|
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| Treatment Period 3 (28 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | FF 200 µg, FF 100 µg, and Placebo Via DPI | Participants received FF 200 µg inhalation powder OD in the evening, FF 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a Dry Powder Inhaler (DPI) for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| BG001 | FP 200 µg, FP 100 µg, and Placebo Via DISKUS | Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| BG002 | 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 |
| |||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| 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 | Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period | Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response. | Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication | Posted | Least Squares Mean | Standard Error | Liters | Day 28 of the relevant treatment period (up to Study Day 112) |
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| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs. | ITT Population | Posted | Number | participants | From the first dose of the study medication up to Week 16/Early Withdrawal |
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| Secondary | 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period | A 24-hour urine sample was collected, and the 24-hour urinary cortisol excretion was analyzed at Day 28 of the relevant treatment period. | Urine Cortisol (UC) Population: participants who had both a Baseline urine sample and at least one urine sample from the end of a treatment period that did not have confounding factors that could affect the interpretation of results | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomoles per 24 hours | Day 28 of the relevant treatment period (up to Study Day 112) |
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| Secondary | Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period | Detailed oropharyngeal examination for visual evidence of oropharyngeal candidiasis was performed at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Number | participants | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
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| Secondary | Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period | Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
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| Secondary | Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period | Heart rate was measured at Day 0 (clinic visits 2, 4, and 6) and Day 28 (clinic visits 3, 5, and 7) of the relevant treatment period. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | beats per minute | Day 0 and Day 28 of the relevant treatment period (up to Study Day 112) |
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| Secondary | Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods | Participants were withdrawn from the study due to worsening of asthma (lack of efficacy) if they experienced a clinical asthma exacerbation or if clinic FEV1 fell below the FEV1 stability limit, or if during the 7 days immediately preceeding a visit the participant experienced either four or more days in which the PEF had fallen below the PEF stability limit or three or more days in which >=12 inhalations/day of albuterol/salbutamol were used. A clinical asthma exacerbation is defined as the worsening of asthma requiring emergency room visits, hospitalization, or treatment with an asthma medication (inhaled or systemic corticosteroids) other than study medication or rescue salbutamol/albuterol. | ITT Population | Posted | Number | participants | From the first dose of the study medication up to Week 16/Early Withdrawal |
|
Serious adverse events (SAEs) and non-serious AEs were collected from the first dose of the study medication up to Week 16/Early Withdrawal.
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
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 | Placebo | Participants received placebo BID via the Dry Powder Inhaler (DPI) or the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 0 | 187 | 2 | 187 | ||
| EG001 | FF 200 µg OD | Participants received FF 200 µg inhalation powder OD in the evening from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 0 | 140 | 7 | 140 | ||
| EG002 | FF 100 µg BID | Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 0 | 142 | 7 | 142 | ||
| EG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 0 | 42 | 0 | 42 | ||
| EG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. | 0 | 43 | 0 | 43 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| 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
| Lack of Efficacy |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Male |
|
| American Indian (AI) or Alaska Native (AN) |
|
| Japanese/East Asian HER/South East Asian HER |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| African American/African HER & AI or AN & White |
|
| African American/African Heritage & White |
|
| Mean Difference (Final Values) |
| 0.098 |
| 2-Sided |
| 95 |
| 0.054 |
| 0.142 |
| No |
| Superiority or Other |
| ANCOVA | 0.020 | Mean Difference (Final Values) | 0.087 | 2-Sided | 95 | 0.014 | 0.161 | No | Superiority or Other |
| ANCOVA | 0.641 | Mean Difference (Final Values) | 0.011 | 2-Sided | 95 | -0.035 | 0.056 | Yes | Non-Inferiority or Equivalence | Non-inferiority was demonstrated if the lower limit of the confidence interval (0.025, 1-sided significance level) for the mean difference in trough FEV1 of FF 200 µg OD versus FF 100 µg BID was greater than -110 milliliters. |
| ANCOVA | <0.001 | Mean Difference (Final Values) | 0.132 | 2-Sided | 95 | 0.059 | 0.205 | No | Superiority or Other |
| OG002 | FF 100 µg BID | Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
|
|
| FF 100 µg BID |
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
|
|
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
|
|
Participants received FF 100 µg inhalation powder BID from the DPI for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
| OG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
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| OG003 | FP 200 µg OD | Participants received FP 200 µg inhalation powder OD PM from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
| OG004 | FP 100 µg BID | Participants received FP 100 µg inhalation powder BID from the DISKUS inhaler for 28 days during one of the 3 treatment periods. Each treatment period was followed by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study. |
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Participants received FP 200 µg inhalation powder OD in the evening, FP 100 µg inhalation powder BID, and placebo BID in one of the three treatment periods. All treatments were administered via a DISKUS for 28 days. Each of the 3 treatment periods was separated by a washout period of 14 days. Participants were provided supplemental albuterol/salbutamol (inhalation aerosol) to be used as needed throughout the study.
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