Status:
TERMINATED
Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
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) ...
Detailed Description
This is a randomized, parallel, multicenter, 12-week study in adolescent and adult patients with mild-to-moderate asthma, to evaluate the efficacy and safety of Armstrong's Albuterol-HFA MDI, in compa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00635505
Start Date
September 1 2007
End Date
August 1 2008
Last Update
July 15 2013
Active Locations (42)
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1
Pulmonary Associates of Mobile, PC
Mobile, Alabama, United States, 36608
2
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647
3
Allergy Asthma & Respiratory Care Medical Center
Long Beach, California, United States, 90806
4
Allergy & Asthma Care Center
Long Beach, California, United States, 90808