Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Teva Branded Pharmaceutical Products R&D, Inc.2 sites in 1 country49 target enrollmentJuly 25, 2007

ConditionsAsthma

InterventionsAlbuterol-HFA-BAI Albuterol-HFA-MDI

DrugsAlbuterol-HFA-MDI Albuterol-HFA-BAI

Overview

Phase: Phase 4
Intervention: Albuterol-HFA-BAI
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 49
Locations: 2
Primary Endpoint: Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

Registry

clinicaltrials.gov

Start Date

July 25, 2007

End Date

October 24, 2008

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Asthma of a minimum of 6 months duration
•Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
•Reversible bronchoconstriction of \>12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
•The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
•Ability to perform spirometry reproducibly
•Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
•Can tolerate withdrawal of applicable medications for qualification at screening
•Otherwise healthy individuals
•Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria

•Allergy or sensitivity to albuterol
•Exposure to investigational drugs within 30 days prior to the screening visit
•Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
•Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
•The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
•Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
•Hospitalization for acute exacerbation of asthma more than twice in past year
•Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
•An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
•History and/or presence of any clinically significant non-asthmatic acute or chronic disease

Arms & Interventions

Albuterol-HFA-BAI

Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.

Intervention: Albuterol-HFA-BAI

Albuterol-HFA-MDI

Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.

Intervention: Albuterol-HFA-MDI

Outcomes

Primary Outcomes

Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2

Time Frame: Baseline, Up to 2 hours postdose

The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period.

Secondary Outcomes

Percent Change From Baseline in FEV1 Within 30 Minutes Postdose(Baseline up to 30 minutes postdose)
Percent Change From Baseline in FEV1 up to 2 Hours Postdose(Baseline up to 2 hours postdose)
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2(Baseline up to 2 hours postdose)
Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose(Baseline up to 2 hours postdose)
Time to Maximum Increase in FEV1(Baseline up to 2 hours postdose)