Phase 3
Completed N=95
Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI in Pediatric Asthmatics
Source: ClinicalTrials.gov NCT00308685 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 — 13.807; 8.644 percent change — p=0.0002
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is designed to evaluate the repeat-dose safety and effectiveness of a bronchodilator inhaler relative to placebo (inactive drug inhaler) in children aged 4-11 years with asthma. The dosing period lasts three weeks and starts following a three-week run-in period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22 |
13.807; 8.644 | 0.0002 sig |
| SECONDARY Baseline-Adjusted Area Under the Percent-Predicted FEV1 Versus Time Curve Over 6 Hours (PPFEV1 AUEC0-6) at Day 22 |
29.473; 11.672; 43.182; 6.767 | — |
Eligibility Criteria
Inclusion Criteria
- Persistent asthma of a minimum of six months duration that has been stable for at least four weeks prior to screening
- Male and female children aged 4-11 years, inclusive, with predicted forced expiratory volume in 1 second (FEV1) 60-90%
- Ability to perform spirometry
- Demonstrate 12% airways reversibility
Exclusion Criteria
- Require continuous treatment with beta-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids
- Presence of any non-asthmatic clinically-significant acute or uncontrolled chronic diseases
Data sourced from ClinicalTrials.gov (NCT00308685). 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.