Phase 3
Completed N=742
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
Source: ClinicalTrials.gov NCT00419952 ↗Enrolled (actual)
742
Serious AEs
3.6%
Results posted
Oct 2012
Primary outcomePrimary: Total Number of Asthma Exacerbations — 36; 61 Exacerbations
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Asthma Exacerbations |
36; 61 | — |
| SECONDARY Asthma Exacerbations |
29; 51 | — |
| SECONDARY QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG) |
-0.11; -0.31 | — |
| SECONDARY Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment |
4; 3 | — |
| SECONDARY Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment |
4; 3 | — |
| SECONDARY Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment |
2; 1 | — |
| SECONDARY Diary Assessments - Rescue-free Day |
15.88; 10.62 | — |
| SECONDARY Diary Assessments - Symptom-free Day |
9.46; 7.58 | — |
| SECONDARY Diary Assessments - Asthma-control Day |
16.68; 11.62 | — |
| SECONDARY Onset of Effect Questionnaire (OEQ) |
165; 157 | — |
| SECONDARY Peak Expiratory Flow (PEF) in Morning |
30.13; 19.73 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) |
0.08; -0.01 | — |
| SECONDARY Asthma Treatment Satisfaction Measure (ATSM) |
47.99; 45.64 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00419952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.