NCT00634829

Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction

Randomized, Double-Blind, Controlled, Single-Dose, Three-Treatment, Cross-Over Study of The Protective Effects Of Albuterol-HFA In Preventing Exercise-Induced Bronchoconstriction In Adolescent And Adult Asthmatic Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will evaluate and establish the protective effects of Amphastar's Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1) Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in comparison to the Active and Placebo Controls. Analyses will be performed to determine if the Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.

Detailed description

The prevalence of exercise-induced bronchoconstriction (EIB) has been reported to be around 70% to 75% among patients with clinically established asthma. Airway cooling and drying are thought to cause the release of inflammatory mediators, such as histamine and leukotrienes, which then mediate clinical EIB symptoms. Pretreatment with a variety of medications will ameliorate EIB. Albuterol has been found to be more effective in minimizing EIB than theophylline, ipratropiom, cromoglycate, etc. Tested using a treadmill exercise challenge, the newer formulations of albuterol MDI with HFA as propellant have been demonstrated to be as effective as those with CFC as propellant in protecting asthma patients from EIB in children and adults. As a part of the Amphastar Pharmaceuticals' clinical development plan, the current study examines the clinical efficacy of A004, Armstrong Pharmaceuticals' Albuterol HFA oral inhalation MDI, in preventing EIB in adolescent and adult asthmatic patients. This is a randomized, double-blind, active and placebo-controlled, three-treatment, cross-over study, to be conducted in adolescent and adult patients with mild to moderate asthma and demonstrable EIB. All subjects will be screened against the inclusion/exclusion criteria for enrollment. A computer-generated randomization code will be created by the Amphastar Pharmaceuticals' IT Department, so that each enrolled subject will receive all three double-blinded treatments in randomized sequence. Each treatment is followed by a standardized exercise challenge and a series of FEV1 measurements during the 90 min post-exercise period. The three crossover Treatment Arms are: * Treatment T (Armstrong's Test Drug: Albuterol-HFA); * Treatment R (Reference Drug and Active Control: Proventil®-HFA); * Treatment P (Placebo-HFA). By the definition of the crossover design, the three Treatment Arms are expected to consist comparably of 24 evaluable subjects. The consecutive study sessions will be separated by an interval of 1-14 days.

Conditions

• Asthma
• Bronchospasm

Interventions

Type	Name	Description
DRUG	albuterol (Armstrong Albuterol HFA)	2 inhalations of 108 mcg albuterol sulfate prior to exercise, single dose
DRUG	Albuterol Sulfate (Provenetil-HFA)	2 inhalations of Proventil-HFA, 108 mcg/inhalation prior to exercise
DRUG	Placebo-HFA	Placebo containing HFA propellant without active drug substance

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-03-13
• Last updated: 2013-07-15

Locations

3 sites across 1 country: United States