An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

Official Title
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A 12-week, Randomised, Double Blind, Active-controlled, Multi-centre, Phase IIIB Study Comparing the Efficacy and Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily Versus Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily, in Adult/Adolescent (> 12 Yrs) Hispanic Subjects With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/formoterol (SYMBICORT) pMDI
* Drug: Budesonide HFA pMDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, Hispanic (self-reported), > 12 years of age Moderate to severe asthma requiring treatment with an inhaled corticosteroid Diagnosis of asthma for at least 6 months Exclusion Criteria: Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) Any significant disease or disorder that may jeopardize a subject's safety

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 |
| --- | --- |
| Active Comparator: Symbicort<br>SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily | Drug: Budesonide/formoterol (SYMBICORT) pMDI<br>* SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily<br>|
| Active Comparator: Budesonide<br>budesonide HFA pMDI 160 μg x 2 actuations twice daily | Drug: Budesonide HFA pMDI<br>* Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning Peak Expiratory Flow (AM PEF) | Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks, with baseline value as covariate. | Baseline (run-in) and throughout 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Pre-defined Asthma Events | Asthma Events, defined as any of: decrease in lung function (FEV1 or AM PEF), use of rescue medication over maximum allowed per day, night awakening requiring use of rescue medication, exacerbation of asthma requiring medical assistance, use of not allowed asthma medication | 12 weeks | 
| Percentage of Participants With Withdrawals Due to Pre-defined Asthma Events | Percentage of participants with Withdrawals Due to Pre-defined Asthma Events as recorded in CRF. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | 12 weeks | 
| Changes Pre-dose Forced Expiratory Volume in 1 Second (FEV1) | Changes in pre-dose FEV1 from baseline to the average value over the treatment period, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | Baseline, 2, 6 and 12 weeks | 
| Change From Baseline in a Evening Peak Expiratory Flow (PM PEF) | Change from baseline (average of daily records over the 14 days of run-in) to the average of daily records over the treatment period of 12 weeks with baseline as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | Baseline (run-in) and throughout 12 weeks | 
| Change in Nighttime Asthma Symptom Score From Baseline Through 12 Weeks | Change from baseline in average of daily scores for nighttime asthma over 12 weeks of treatment, with baseline value as covariate. Daily scale: 0 = No symptoms 1 = Mild symptoms 2 = Moderate symptoms 3 = Severe symptoms | Baseline (run-in) and throughout 12 weeks | 
| Change in Daytime Asthma Symptom Score From Baseline Through 12 Weeks | Change from baseline in average of daily scores for daytime asthma over 12 weeks of treatment, with baseline value as covariate. Daily scale: 0 = No symptoms 1 = Mild symptoms 2 = Moderate symptoms 3 = Severe symptoms | Baseline (run-in) and throughout 12 weeks | 
| Change in Asthma Related Awakenings Free Nights, From Baseline Through 12 Weeks | Change from baseline in percentage of nights with awakenings due to asthma over 12 weeks of treatment, with baseline value as covariate. | Baseline (run-in) and throughout 12 weeks | 
| Change From Baseline in Rescue Medication Use Over 12 Weeks of Treatment | Change from baseline in rescue medication use over 12 weeks of treatment with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | Baseline (run-in) and throughout 12 weeks | 
| Change From Baseline in Rescue-free Days Over 12 Weeks of Treatment | Change from baseline in percentage of rescue-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | Baseline (run-in) and throughout 12 weeks | 
| Change From Baseline in Symptom-free Days Over 12 Weeks of Treatment | Change from baseline in percentage of symptom-free days over 12 weeks of treatment, with baseline value as covariate. Includes all subjects who were randomised, took at least one dose of study medication and contributed sufficient data for the endpoint to be calculated. | Baseline (run-in) and throughout 12 weeks | 
| Subject Global Assessment | The assessment was made using a 5-point Likert scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1 and 2 combined as Yes and points 3, 4, 5 as No. Percent of Participants that gave positive responses. | Baseline and week 12 | 
| Physician Global Assessment | The assessment was made using a 5-point scale with 1=much better, 2=somewhat better, 3=comparable, 4=somewhat worse, and 5=much worse transformed to a binary variable with points 1and 2 combined as Yes and points 3, 4, 5 as No. Percent of Participants that gave positive responses. | Baseline and week 12 | 
| Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Control Relief Index | Mean scores (6-points scale, where 1-means the most positive opinion and 6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction. | Week 12 | 
| Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Overall Perception of Medication | Mean scores (6 or 5-points scale, where 1-means the most positive opinion and 5/6-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction. | Week 12 | 
| Patient Satisfaction With Asthma Medication (PSAM) in Term of Domain: Comparison With Other Medications | Mean scores (5-points scale, where 1-means the most positive opinion and 5-the most negative opinion) were calculated for items in domain. 6-point response options were scored on a 0±100 scale, where 100 represented the highest level of satisfaction and 0 the lowest level of satisfaction. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Moderate asthma, Severe asthma