Phase 4
Completed N=311
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
Source: ClinicalTrials.gov NCT00702325 ↗Enrolled (actual)
311
Serious AEs
1.0%
Results posted
Nov 2012
Primary outcomePrimary: Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period — 0.16; 0.07 Liters
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) Averaged Over Treatment Period |
0.16; 0.07 | — |
| SECONDARY Change From Baseline in Morning Peak Expiratory Flow (AM PEF) Averaged Over the Treatment Period |
25.34; 7.53 | — |
| SECONDARY Change From Baseline in Evening Peak Expiratory Flow (PM PEF) Averaged Over the Treatment Period |
21.61; 7.67 | — |
| SECONDARY Change From Baseline in Pre-dose Forced Vital Capacity (FVC) Averaged Over the Treatment Period |
0.14; 0.07 | — |
| SECONDARY Change From Baseline in Pre-dose Forced Expiratory Flow (FEF 25-75%) Averaged Over the Treatment Period |
0.21; 0.12 | — |
| SECONDARY Number of First Predefined Asthma Events by Inhaled Corticosteroid (ICS) Dose at Entry |
57; 67 | — |
| SECONDARY Number of Withdrawals Due to a Predefined Asthma Event |
18; 28 | — |
| SECONDARY Change From Baseline in Total Average Daily Asthma Symptom Score Averaged Over the Treatment Period |
-0.35; -0.23 | — |
| SECONDARY Change From Baseline in Nighttime Asthma Symptom Score Averaged Over the Treatment Period |
-0.38; -0.26 | — |
| SECONDARY Change From Baseline in Daytime Asthma Symptom Score Averaged Over the Treatment Period |
-0.33; -0.24 | — |
| SECONDARY Change From Baseline in Awakening-free Nights Averaged Over the Treatment Period |
17.51; 11.85 | — |
| SECONDARY Change From Baseline to the Average in Total Rescue Medication Use Averaged Over the Treatment Period |
-1.27; -0.62 | — |
| SECONDARY Change From Baseline to the Average in Nighttime Rescue Medication Use Averaged Over the Treatment Period |
-0.79; -0.35 | — |
| SECONDARY Change From Baseline to the Average in Daytime Medication Use Averaged Over the Treatment Period |
-0.48; -0.27 | — |
| SECONDARY Change From Baseline to the Average in Rescue Medication-free Days Averaged Over the Treatment Period |
29.31; 17.70 | — |
| SECONDARY Change From Baseline in Asthma Symptom-free Days Averaged Over the Treatment Period |
23.99; 17.55 | — |
| SECONDARY Change From Baseline to the Average for Asthma-control Days Averaged Over the Treatment Period |
21.89; 15.12 | — |
| SECONDARY 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) |
123; 112; 109; 95 | — |
| SECONDARY Change From Baseline to End of Treatment in Overall Score on the Asthma Quality of Life Questionnaire-Standardized (AQLQ[S]) |
0.55; 0.33 | — |
| SECONDARY Proportion of Participants Who Reported on the Asthma Control Test (ACT) That Their Asthma Was Controlled at the Last Week of Treatment |
0.524; 0.518 | — |
| SECONDARY Change From Baseline to Last Week of Treatment in Scores on the Asthma Impact Survey (AIS) |
-4.05; -2.72 | — |
| SECONDARY 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) |
112; 99; 100; 81 | — |
| SECONDARY 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) |
113; 95; 101; 81 | — |
| SECONDARY 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) |
96; 83; 86; 70 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00702325). 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.