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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000683-99 | EudraCT Number | ||
| U1111-1133-6333 | Registry Identifier | WHO | |
| CL-9709-301-RDCTID | Registry Identifier | Israel |
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The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIC 160 | Active Comparator | Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg) |
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| CIC 320 | Active Comparator | Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg) |
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| CIC 640 | Active Comparator | Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg) |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Questionnaire (ACQ) Score at Baseline | The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Baseline |
| Change From Baseline in ACQ Score to Tlast | The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Course of ACQ | The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina | |||||
Participants with a historical diagnosis of persistent bronchial asthma for at least 6 months,treated with a stable inhaled corticosteroid (ICS)dose for at least 12 weeks were enrolled in a single-blind baseline period receiving 160 microgram(mcg)ciclesonide,then a double-blind treatment period in 1 of 3 treatment arms: ciclesonide 160,320,640 mcg.
Participants took part in the study at 5 investigative sites in Argentina, Brazil, Germany, Israel and Russia from 10 November 2011 to 15 August 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Baseline Period: Ciclesonide 160 mcg | Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. |
| FG001 | Treatment Period: Ciclesonide 160 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, Week 52 (Treatment period) |
| Number of Weeks With Well-controlled Asthma Over the Course of the Study | The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Baseline up to Week 52 (treatment period) |
| Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study | Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Week 52 |
| Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement | Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Baseline up to Week 52 (treatment period) |
| Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point | Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Baseline up to Week 52 (treatment period) |
| Number of Participants Reporting Time to First Asthma Exacerbation | Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication | Baseline up to Week 52 (treatment period) |
| Number of Participants Reporting Asthma Exacerbations Rates | Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included. | Baseline up to Week 52 (treatment period) |
| Number of Participants With Markedly High Benefits | The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included. | Week 1 up to Week 52 |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
| Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs | Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
| Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings | Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
| Number of Participants With Markedly Abnormal Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
| Capital Federal, Buenos Aires |
| Argentina |
| Rosario | Argentina |
| Rosario-Santa Fe | Argentina |
| Salta | Argentina |
| San Miguel de Tucumán | Argentina |
| Florianópolis | Brazil |
| Goiânia | Brazil |
| Porto Alegre | Brazil |
| Rio de Janiero | Brazil |
| Santo André | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Berlin | Germany |
| Bonn | Germany |
| Landsberg | Germany |
| Rüdersdorf | Germany |
| Schwetzingen | Germany |
| Beersheba | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Kfar Saba | Israel |
| Petah Tikva | Israel |
| Rehovot | Israel |
| Tel Aviv | Israel |
| Barnaul | Russia |
| Moscow | Russia |
| Novosibirsk | Russia |
| Saint Petersburg | Russia |
| Tomsk | Russia |
Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
| FG002 | Treatment Period: Ciclesonide 320 mcg | Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| FG003 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) was defined as all randomized participants who took at least 1 dose of double-blind study medication.Baseline data was summarized only for those participants who entered treatment period which was the core period of the trial.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Period: Ciclesonide 160 mcg | Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| BG001 | Treatment Period: Ciclesonide 320 mcg | Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| BG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | meter (m) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms (kg) |
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| Body Mass Index | Mean | Standard Deviation | kilogram per meter square (kg/m^2) |
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| History of exacerbations | Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. | Number | participants |
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| Smoking Status | Number | participants |
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| Prestudy ICS dose | Number | participants |
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| Baseline asthma control questionnaire (ACQ) | ACQ=5 questions about symptoms,1 question about beta 2-agonist use and 1 about lung function (FEV1% predicted).Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale.The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | Mean | Standard Deviation | units on scale |
| ||||||||||||||
| Pre-forced expiratory volume in 1 second (FEV1) | Pre-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration prior to salbutamol administration. | Mean | Standard Deviation | liter (L) |
| ||||||||||||||
| Post-FEV1 | Post-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration after salbutamol administration. | Mean | Standard Deviation | L |
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| FEV1 reversibility | Reversibility is assessed using FEV1 measurements. Percent reversibility is calculated as the difference between highest FEV1 after salbutamol and highest FEV 1 before salbutamol divided by highest FEV 1 before salbutamol. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. | Mean | Standard Deviation | percent reversibility |
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| Pre FEV1 predicted | Pre-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration prior to salbutamol administration. It is converted to the percentage of predicted FEV1 based on age, gender, weight and race of participants. Generally, values between 80% to 120% are considered normal. | Mean | Standard Deviation | percent of predicted |
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| Post FEV1 predicted | Post-FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration after salbutamol administration. It is converted to the percentage of predicted FEV1 based on age, gender, weight and race of participants. Generally, values between 80% to 120% are considered normal. | Mean | Standard Deviation | percent of predicted |
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| 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 | Asthma Control Questionnaire (ACQ) Score at Baseline | The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Mean | Standard Error | units on a scale | Baseline |
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| Primary | Change From Baseline in ACQ Score to Tlast | The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Mean | Standard Error | units on a scale | Week 52 |
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| Secondary | Time Course of ACQ | The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Median | Full Range | Weeks | Baseline, Week 52 (Treatment period) |
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| Secondary | Number of Weeks With Well-controlled Asthma Over the Course of the Study | The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | weeks | Baseline up to Week 52 (treatment period) | weeks | weeks |
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| Secondary | Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study | Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | participants | Week 52 |
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| Secondary | Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement | Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | participants | Baseline up to Week 52 (treatment period) |
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| Secondary | Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point | Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | participants | Baseline up to Week 52 (treatment period) |
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| Secondary | Number of Participants Reporting Time to First Asthma Exacerbation | Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | participants | Baseline up to Week 52 (treatment period) |
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| Secondary | Number of Participants Reporting Asthma Exacerbations Rates | Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included. | The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period. | Posted | Number | participants | Baseline up to Week 52 (treatment period) |
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| Secondary | Number of Participants With Markedly High Benefits | The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included. | Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received. | Posted | Number | participants | Week 1 up to Week 52 |
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| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received. | Posted | Number | participants | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
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| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs | Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received. | Posted | Number | participants | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
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| Secondary | Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings | Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received. | Posted | Number | participants | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
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| Secondary | Number of Participants With Markedly Abnormal Laboratory Values | The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication. | Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received. | Posted | Number | participants | Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56) |
|
Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days for a serious adverse event after the last dose of double-blind study drug.
Investigator documented any AEs and abnormal laboratory findings.Any event spontaneously reported was recorded,irrespective of the relation to study treatment.1 participant erroneously randomized into 160 mcg arm,actually received 640 mcg dose.For safety analysis,participants were analyzed based on the treatment they actually received.
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 | Baseline Period: Ciclesonide 160 mcg | Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period. | 1 | 520 | 64 | 520 | ||
| EG001 | Treatment Period: Ciclesonide 160 mcg | Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. | 6 | 119 | 65 | 119 | ||
| EG002 | Treatment Period: Ciclesonide 320 mcg | Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. | 9 | 122 | 65 | 122 | ||
| EG003 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. | 0 | 126 | 70 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Systematic Assessment |
| |
| Invertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cerebellar ischaemia | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (16.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | AstraZeneca | 1-877-240-9479 | information.center@astrazeneca.com |
| 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 |
|---|---|
| C120481 | ciclesonide |
Not provided
Not provided
Not provided
| Male |
|
| White |
|
| Unknown or Not Reported |
|
| 1 |
|
| 2-3 |
|
| 4+ |
|
| Unknown |
|
| Current |
|
| Former |
|
| Low:>=200 mcg/day(=<)250 mcg/day FP equivalent |
|
| Medium:>250 mcg/dayto=<500 mcg/day FP equivalent |
|
| High:>500 mcg/dayto=<1000 mcg/day FP equivalent |
|
Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
| OG002 | Treatment Period: Ciclesonide 320 mcg | Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
| OG003 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
| OG002 | Treatment Period: Ciclesonide 640 mcg | Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
| OG002 |
| Treatment Period: Ciclesonide 640 mcg |
Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period. |
|
|
|
|