Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Public ClinicalTrials.gov record NCT00635505. 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
Randomized, Placebo-Controlled, Parallel, Multi-Center, 12-Week Study to Evaluate the Efficacy and Safety of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Adult and Adolescent Asthmatic Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered dose inhaler (MDI) of Albuterol (Treatment T), in comparison with: 1. Placebo control: (HFA propellant only, Treatment P); and 2. Active control: 3M/Key's Proventil-HFA (Treatment R). The treatments will be given as self-administered oral inhalations in adult and adolescent patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week study is two actuations four times daily (QID).
Study identification
- NCT ID
- NCT00635505
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Interventions
- albuterol HFA (Armstrong's) Drug
- albuterol HFA (Proventil HFA) Drug
- HFA placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years to 75 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
- Sep 2007 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Aug 2008 (Actual)
- Last update posted
- Jul 15, 2013
2007 – 2008
United States locations
- U.S. sites
- 42
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates of Mobile, PC | Mobile | Alabama | 36608 | — |
| Allergy & Asthma Specialists Medical Group | Huntington Beach | California | 92647 | — |
| Allergy Asthma & Respiratory Care Medical Center | Long Beach | California | 90806 | — |
| Allergy & Asthma Care Center | Long Beach | California | 90808 | — |
| Southern California Research | Mission Viejo | California | 92691 | — |
| CHOC PSF, AMC, Divison AA and I | Orange | California | 92868 | — |
| Clinical Trials of Orange County | Orange | California | 92868 | — |
| Peninsula Research Associates | Rolling Hills Estates | California | 90274 | — |
| Allergy Associates Medical Group | San Diego | California | 92120 | — |
| Allergy & Asthma Associates of Santa Clara Valley Research Centere | San Jose | California | 95117 | — |
| Bensch Research Associates | Stockton | California | 95207 | — |
| Colorado Allergy and Asthma Centers | Denver | Colorado | 80230 | — |
| Colorado Allergy and Asthma Centers | Lakewood | Colorado | 80401 | — |
| Rocky Mountain center for Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| Waterbury Pulmonary Research | Waterbury | Connecticut | 06708 | — |
| Allergy and Asthma Care of Florida | Ocala | Florida | 34471 | — |
| Brandon-Valrico Center for Allergy and Astham Research,LLC | Valrico | Florida | 33594 | — |
| Atlanta Allergy and Asthma Clinic | Woodstock | Georgia | 30188 | — |
| Family Allergy and Asthma Research Institute | Louisville | Kentucky | 40215 | — |
| Northeast Medical Research Group | North Dartmouth | Massachusetts | 02747 | — |
| Park Nicollet Institute | Minneapolis | Minnesota | 55416 | — |
| MEDEX Healthcare Research, Inc. | St Louis | Missouri | 63117 | — |
| The Clinical Research Center, LLC | St Louis | Missouri | 63141 | — |
| Clinical Research Group of Montana | Bozeman | Montana | 59718 | — |
| Montant Medical Research | Missoula | Montana | 59808 | — |
| Asthma and Allergy Center, PC | Papillion | Nebraska | 68046 | — |
| New Horizons Clinical Research | Cincinnati | Ohio | 45242 | — |
| Toledo Center for Clinical Research | Sylvania | Ohio | 43560 | — |
| Integrated Medical Research | Ashland | Oregon | 97520 | — |
| Allergy & Asthma Research Group | Eugene | Oregon | 97504 | — |
| Allergy Asthma and Dermatology Research | Lake Oswego | Oregon | 97035 | — |
| Clinical Research Institute of Southern Oregon | Medford | Oregon | 97504 | — |
| Allergy Associates Research Center | Portland | Oregon | 97213 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| Pharmaceutical Research & Consulting, Inc. | Dallas | Texas | 25231 | — |
| Allergy and Asthma Associates of Houston | Houston | Texas | 77054 | — |
| Clinical Trials of North Houston | Houston | Texas | 77070 | — |
| Kerrville Allergy and Asthma Associates | Kerrville | Texas | 78028 | — |
| Biogenics Research Institute | San Antonio | Texas | 78229 | — |
| Sylvania Research Associates | San Antonio | Texas | 78229 | — |
| Virginia Adult and Pediatric Allergy and Asthma, PC | Richmond | Virginia | 23229 | — |
| Asthma, Inc. | Seattle | Washington | 98105 | — |
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 NCT00635505, 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 15, 2013 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00635505 live on ClinicalTrials.gov.