Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients

NCT ID: NCT00635505

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-08-31

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) 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).

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 comparison to a Placebo Control and an Active Control of Proventil-HFA. While Albuterol-HFA (Treatment T) and Placebo (Treatment P) will be double-blinded to both the subjects and investigational staff, the active comparator drug, Proventil-HFA (Treatment R), can only be evaluator-blinded, due to: (1) its physical appearance differing from that of the T and P devices; and (2) unavailability of a Proventil-HFA placebo which would otherwise be used for a double-dummy design. All study medications will have the canisters and all product-identifying text or graphics (e.g., molded text on actuator) masked so that the treatments cannot be identified. No subject in any study arm will be given any information that could reveal the nature of the treatment given. All study subjects will be instructed not to reveal or discuss the study medications to the study staff or other subjects. The designated study evaluator(s), who conduct the clinical visits and safety and efficacy evaluations and perform the data recording and transcription, will be blinded to the study medications.

All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:

Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.

Randomization is achieved with blocks of six (6), with four (4) patients receiving Albuterol-HFA for every one (1) patient receiving Proventil-HFA and every one (1) receiving the Placebo-HFA. At each Clinical Visit that takes place every 3 weeks, the double-blinded (T, P) or evaluator-blinded (R) study drugs will be distributed in resealable masking pouches to the subjects of each arm.

An additional aim of the study is to evaluate the effect of weekly cleaning on the Albuterol-HFA MDI device clinical performance throughout the four, 3-week life-of-device treatment cycles, in conformance with the FDA's specific requirements.

Arms:

All subjects will be screened for enrollment, and will be randomized into the following three treatment groups in a double-blinded (for Treatments T and P) or evaluator-blinded (for Treatment R) manner:

Treatment T (Albuterol-HFA, N=200): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment R (Proventil-HFA, N=50): 216 mcg albuterol sulfate (equivalent to 180 mcg albuterol base), QID; Treatment P (Placebo-HFA, N=50): two actuations of placebo, QID.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

T

albuterol HFA 180 mcg QID

Group Type: EXPERIMENTAL

albuterol HFA (Armstrong's)

Intervention Type: DRUG

180 mcg QID 12 weeks

R

180 mcg QID 12 weeks

Group Type: ACTIVE_COMPARATOR

albuterol HFA (Proventil HFA)

Intervention Type: DRUG

180 mcg QID 12 weeks

P

2 actuations QID 12 weeks or until use of rescue drug

Group Type: PLACEBO_COMPARATOR

HFA placebo

Intervention Type: DRUG

2 actuations QID 12 weeks or until use of rescue drug

Interventions

albuterol HFA (Armstrong's)

180 mcg QID 12 weeks

Intervention Type: DRUG

albuterol HFA (Proventil HFA)

180 mcg QID 12 weeks

Intervention Type: DRUG

HFA placebo

2 actuations QID 12 weeks or until use of rescue drug

Intervention Type: DRUG

Other Intervention Names

Proventil HFA

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amphastar Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Asthma and Allergy Center, PC

Papillion, Nebraska, United States

New Horizons Clinical Research

Cincinnati, Ohio, United States

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Integrated Medical Research

Ashland, Oregon, United States

Allergy & Asthma Research Group

Eugene, Oregon, United States

Allergy Asthma and Dermatology Research

Lake Oswego, Oregon, United States

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Allergy Associates Research Center

Portland, Oregon, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Pharmaceutical Research & Consulting, Inc.

Dallas, Texas, United States

Allergy and Asthma Associates of Houston

Houston, Texas, United States

Clinical Trials of North Houston

Houston, Texas, United States

Kerrville Allergy and Asthma Associates

Kerrville, Texas, United States

Biogenics Research Institute

San Antonio, Texas, United States

Sylvania Research Associates

San Antonio, Texas, United States

Virginia Adult and Pediatric Allergy and Asthma, PC

Richmond, Virginia, United States

Asthma, Inc.

Seattle, Washington, United States

Countries

United States

Other Identifiers

API-A004-CLN-C

Identifier Type: -

Identifier Source: org_study_id