Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

Study Overview
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Brief Summary
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To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Official Title
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A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide / formoterol fumarate (SYMBICORT)
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: African American (self-reported) Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition. FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal. Exclusion Criteria: Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2. Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2. Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Budesonide / formoterol fumarate (SYMBICORT)<br>* 160/4.5 μg x 2 actuations twice daily (bid)<br>* Other names: SYMBICORT;|
| Active Comparator: 2<br> | Drug: Budesonide<br>* inhalation powder 180 μg x 2 inhalations bid (PULMICORT)<br>* Other names: PULMICORT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period | Mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period | Mean change of the FEF (25-75%) value at the baseline (Visit 3) compared to average value of the FEF (25-75%) recorded at visits during treatment period (to week 12). The mean change was calculated. | Baseline to 12 weeks | 
| Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry | Total number of participants with any first predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma medication) | 12 weeks | 
| Number of Withdrawals Due to a Predefined Asthma Event | Total number of participants who withdrew due to a predefined asthma event (decrease in FEV1 ≥ 20%,or to <40% of predicted normal value,12 puffs of albuterol pMDI per day on 3 or more days, decrease in morning PEF ≥ 20% on 3 or more days, use of rescue medication for 2 or more nights, emergency treatment, hospitalization, use of other asthma meds) | 12 weeks | 
| Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of total asthma symptoms score (treatment average) by Inhaled Corticosteroid (ICS) dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of nighttime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS) | Baseline to 12 weeks | 
| Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period | Diary assessment of daytime asthma symptoms score (treatment average) by ICS dose at entry. Asthma symptoms are cough, wheeze and shortness of breath. Each symptom is usually rated from 0-3: 0-no symptoms, 1-mild, 2-moderate and 3-severe. Change from baseline (Visit 3) mean value to average value recorded at visits during treatment period; full analysis set (FAS) | Baseline to 12 weeks | 
| Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period | Diary assessment of number of nights free from awakenings due to asthma; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period | Diary assessment of total daily puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period | Diary assessment of total nighttime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period | Diary assessment of total daytime puffs of rescue medication used for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period | Diary assessment of total (percent) days free from rescue medication use for asthma symptoms relief; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period | Diary assessment of number (percent) of days free from asthma symptoms by ICS dose at entry; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period | Diary assessment of number (percent) of asthma-control days (defined as days that were free of symptoms and nighttime and daytime rescue medication use); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at last week of treatment - During the past week, you could feel your medication begin to work right away | 12 week | 
| Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S]) | Mean change in overall score at end of treatment for participants age 17 years and older (scores ranged from 1 to 7, with higher scores indicating better quality of life); mean change from baseline (Visit 3) value to average value recorded at visits during treatment period | Baseline to 12 weeks | 
| Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment | There are 5 questions in the survey, and each question has 5 responses (total score for each question can range from 1 to 5). To score the survey, responses to the 5 questions are added to yield a total score that ranges from 5 (poor control of asthma control) to 25 (complete control of asthma). Score of 20 or higher was indicative of well-controlled asthma. | 12 weeks | 
| Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS) | There are 6 questions in the survey, and each question has 5 responses (total score for each question can range from 6 to 13). Responses to the 6 questions were added to yield a total score that ranged from 36 to 78. Scoring is based on a norm-based method. Higher AIS scores indicated more asthma impact and poorer quality of life; mean change from baseline (Visit 3) value to average value recorded at visits during treatment period. | Baseline to 12 weeks | 
| Perception of Onset of Medication Effect at Last Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at last week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work. | 12 week | 
| Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 2 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 2 at first week of treatment - During the past week, you could feel your medication begin to work right away | 1 week | 
| Perception of Onset of Medication Effect at First Week of Treatment Assessed by Number of Participants Who Agreed With Item 5 on the Onset of Effect Questionnaire (OEQ) | Diary assessment of participants age 12 years and older and 18 years and older who agreed with OEQ Item 5 at first week of treatment - During the past week, you were satisfied with how quickly you felt your study medication began to work. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma