Phase 3
N=103
Albuterol HFA MDI in Pediatric Participants With Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00577655 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22 — 12.849; 9.353 percentage change from baseline — p=0.0138
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Albuterol (Drug); Placebo (Drug); Proventil® HFA (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22 |
12.849; 9.353 | 0.0138 sig |
| PRIMARY Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22 |
17.558; 12.127 | 0.0403 sig |
| SECONDARY Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases |
12.621; 8.085; 12.601; 9.534 | 0.0031 sig |
| SECONDARY Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases |
20.040; 12.468; 16.776; 12.994 | 0.0074 sig |
| SECONDARY Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines |
31.046; 21.338; 25.060; 24.167 | 0.0507 |
| SECONDARY Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines |
120.82; 90.693; 139.42; 96.842 | 0.2186 |
| SECONDARY Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case) |
95.898; 89.374; 94.650; 90.652 | 0.0017 sig |
| SECONDARY Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22 |
43.95; 45.25; 41.54; 61.05 | 0.0647 |
| SECONDARY Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22 |
41.50; 35.00; 34.5; 63.00 | 0.5059 |
| SECONDARY Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22 |
17.6; 9.8; 17.6; 6.4 | 0.3888 |
| SECONDARY Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22 |
33.3; 13.7; 29.4; 14.9 | 0.0343 sig |
| SECONDARY Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22 |
44.2; 19.6; 41.2; 23.4 | 0.0109 sig |
| SECONDARY Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22 |
57.7; 25.5; 56.9; 29.8 | 0.0013 sig |
| SECONDARY Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3 |
0.370; 0.442; 0.376; 0.547; 0.336; 0.474 | 0.4674 |
| SECONDARY The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication |
1.15; 1.06; 1.14; 1.00; 1.16; 0.73 | — |
| SECONDARY Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning |
229.65; 219.72; 229.90; 218.97; 231.28; 221.73 | 0.1391 |
| SECONDARY Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3 |
0.074; 0.075; 0.084; 0.088; 0.078; 0.088 | 0.9846 |
Summary
The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
Eligibility Criteria
Inclusion Criteria
- Male and female child aged 4-11 years, inclusive Asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening.
Exclusion Criteria
- Hospitalization for acute asthma exacerbation greater than two years in 12 months prior to screening and/or received ER treatment or hospitalization for asthma exacerbation.
Data sourced from ClinicalTrials.gov (NCT00577655). 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.