4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma
Public ClinicalTrials.gov record NCT00634517. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group, 4-Week Study to Evaluate the Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Patients With Asthma in Pediatric Patients With Asthma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this population will be evaluated using a population PK approach with sparse blood samples.
Study identification
- NCT ID
- NCT00634517
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 4 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- Nov 30, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Jul 14, 2013
2008
United States locations
- U.S. sites
- 8
- U.S. states
- 3
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| West Coast Clinical Trials Phase 2-4, LLC | Long Beach | California | 90806 | — |
| Allergy Associates Medical Group, Inc. | San Diego | California | 92120 | — |
| Bensch Research Associates | Stockton | California | 95207 | — |
| Integrated Medical Research | Ashland | Oregon | 97520 | — |
| Allergy and Asthma Research Group | Eugene | Oregon | 97401 | — |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | — |
| Allergy Associates Research Center | Portland | Oregon | 97213 | — |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00634517, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2013 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00634517 live on ClinicalTrials.gov.