Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Asthma
In brief
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).
Key facts
- Study ID
- NCT00635505
- Run by
- Amphastar Pharmaceuticals, Inc.
- People needed
- 300
- Starts
- 2007-09-01
- Expected to finish
- 2008-08-01
- Last updated by the study team
- 2013-07-15
Who can join
Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than 12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
You may not qualify if…
- Male and female asthma patients aged 12 - 75 years, in general good health.
- A documented history of mild to moderate asthma, for at-least 6-months prior to Screening, requiring inhaled B2-adrenergic agonists, with or without orally inhaled corticosteroids, for asthma treatment.
- Satisfying criteria of asthma stability, defined as no asthma-related hospitalization or emergency visits, and no significant changes in asthma therapy, over 4 weeks prior to Screening (with exception for switching from long- to short-acting B2-agonists).
- Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods indicated in Appendix II prior to the Screening Baseline FEV1 testing.
- Having a Screening Baseline FEV1 test that falls within 50-90% of the predicted values.
- Airway Reversibility PFT at screening should demonstrate a greater than12% increase in FEV1 at 30 minutes of inhaling 2 actuations of Ventolin-HFA (180 mcg albuterol base).
- Demonstrating satisfactory techniques in the use of metered-dose inhaler (MDIs) and a hand held peak flow meter.
- Female patients of child-bearing potential being non-pregnant and non-lactating at Screening and throughout the study, and using an acceptable method of contraception during the study.
- Has properly consented to participate in this study.
Where it is running
- Pulmonary Associates of Mobile, PC — Mobile, Alabama, United States
- Allergy & Asthma Specialists Medical Group — Huntington Beach, California, United States
- Allergy Asthma & Respiratory Care Medical Center — Long Beach, California, United States
- Allergy & Asthma Care Center — Long Beach, California, United States
- Southern California Research — Mission Viejo, California, United States
- CHOC PSF, AMC, Divison AA and I — Orange, California, United States
- Clinical Trials of Orange County — Orange, California, United States
- Peninsula Research Associates — Rolling Hills Estates, California, United States
- Allergy Associates Medical Group — San Diego, California, United States
- Allergy & Asthma Associates of Santa Clara Valley Research Centere — San Jose, California, United States
- Bensch Research Associates — Stockton, California, United States
- Colorado Allergy and Asthma Centers — Denver, Colorado, United States
- Colorado Allergy and Asthma Centers — Lakewood, Colorado, United States
- Rocky Mountain center for Clinical Research — Wheat Ridge, Colorado, United States
- Waterbury Pulmonary Research — Waterbury, Connecticut, United States
- Allergy and Asthma Care of Florida — Ocala, Florida, United States
- Brandon-Valrico Center for Allergy and Astham Research,LLC — Valrico, Florida, United States
- Atlanta Allergy and Asthma Clinic — Woodstock, Georgia, United States
- Family Allergy and Asthma Research Institute — Louisville, Kentucky, United States
- Northeast Medical Research Group — North Dartmouth, Massachusetts, United States
- Park Nicollet Institute — Minneapolis, Minnesota, United States
- MEDEX Healthcare Research, Inc. — St Louis, Missouri, United States
- The Clinical Research Center, LLC — St Louis, Missouri, United States
- Clinical Research Group of Montana — Bozeman, Montana, United States
- Montant Medical Research — Missoula, Montana, United States
Full record on ClinicalTrials.gov
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