A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With 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 African American population.

Official Title
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A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American 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, African American (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 |
| --- | --- |
| Experimental: Symbicort<br>Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID) | Drug: Budesonide/formoterol (SYMBICORT) pMDI<br>* Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)<br>|
| Experimental: Budesonide<br>Budesonide HFA pMDI 160 ug x 2 actuations BID | Drug: Budesonide HFA pMDI<br>* Budesonide HFA pMDI 160 ug x 2 actuations BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Asthma Exacerbations | An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization. | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Exacerbations | Number of participants with at least 1 exacerbation | 52 Weeks | 
| QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG) | QT interval corrected using the Fridericia formula [QTc (Frid)] - Change from baseline to end of treatment | Baseline and 52 weeks | 
| Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic ventricular (VE) beats - number of participants with shift from normal (<50) to high (≥50) from baseline to visit 4. | Baseline and 2 weeks (visit 4) | 
| Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment | Total ectopic supraventricular (VE) beats - number of participants with shift normal (<50) to high (≥50) from baseline to visit 4. | Baseline and 2 weeks (visit 4) | 
| Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment | Total ventricular runs - number of participants with shift normal (<1) to high (≥1) from baseline to week 2. | Baseline and 2 weeks (visit 4) | 
| Diary Assessments - Rescue-free Day | Calculated as the number of rescue-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % rescue-free days in the baseline period and the active treatment period. A rescue-free day was one in which the patient answered no to having used rescue medication that day | baseline and 52 weeks | 
| Diary Assessments - Symptom-free Day | Calculated as the number of symptom-free days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % symptom-free days in the baseline period and the active treatment period. A symptom-free day was one in which the patient answered no to having symptoms that day | baseline and 52 weeks | 
| Diary Assessments - Asthma-control Day | Calculated as the number of asthma control days divided by the number of non missing days in the baseline period times 100%. The results are expressed as the change in % asthma control days in the baseline period and the active treatment period. An asthma control day was one in which the patient answered no to having symptoms and 0 to the use of rescue medication that day | baseline and 52 weeks | 
| Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 2 in questionnaire During the past week,you could feel your study medication begin to work right away. A positive response was defined as a response of strongly agree or somewhat agree | 1 week | 
| Onset of Effect Questionnaire (OEQ) | Number of participants with positive response to Item 5 in questionnaire During the past week, you were satisfied with how quickly you felt your study medication begin to work. The scale was scored on a 5-point Likert scale from strongly agree to strongly disagree. A positive response was defined as a response of strongly agree or somewhat agree | 1 week | 
| Peak Expiratory Flow (PEF) in Morning | Change in AM PEF from baseline (mean over the 2 weeks run-in) to the average of the randomized treatment period. | baseline and 52 weeks | 
| Forced Expiratory Volume in One Second (FEV1) | Change in pre-dose FEV1 from baseline (end of run-in, visit 3) to the average of the randomized treatment period | baseline and 52 weeks | 
| Asthma Treatment Satisfaction Measure (ATSM) | Overall score - change from baseline to end of treatment. For 11 individual attributes, expectations were subtracted from the outcomes. This difference and the importance rating were combined in a weighted average which was then multiplied by the raw satisfaction measure. The final derived satisfaction measure was transformed to a 0 to 100 scale, with higher scores representing greater satisfaction. | Baseline and 52 weeks | 

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