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

NCT00635505 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-07-15

No results posted yet for this study

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).

Conditions

Interventions

DRUG

albuterol HFA (Armstrong's)

180 mcg QID 12 weeks

DRUG

albuterol HFA (Proventil HFA)

180 mcg QID 12 weeks

DRUG

HFA placebo

2 actuations QID 12 weeks or until use of rescue drug

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635505 on ClinicalTrials.gov