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

Teva Branded Pharmaceutical Products R&D, Inc.1 site in 1 country14 target enrollmentMarch 31, 2003

ConditionsAsthma

InterventionsAlbuterol HFA-BOI Albuterol HFA-MDI

DrugsAlbuterol HFA-BOI Albuterol HFA-MDI

Overview

Phase: Phase 2
Intervention: Albuterol HFA-BOI
Conditions: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 14
Locations: 1
Primary Endpoint: Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.

Detailed Description

This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.

Registry

clinicaltrials.gov

Start Date

March 31, 2003

End Date

August 31, 2003

Last Updated

4 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 diagnosed ≥6 months prior and stable for 4 weeks prior to screening
•Poor inhaler coordination as assessed at screening
•Reversible bronchoconstriction (≥ 12% increase in FEV1)

Exclusion Criteria

•Albuterol allergy
•Investigational drug within 30 days
•Injected corticosteroid within 6 weeks
•Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
•Other criterial apply

Arms & Interventions

Albuterol HFA-BOI

Intervention: Albuterol HFA-BOI

Albuterol HFA-MDI

Intervention: Albuterol HFA-MDI

Outcomes

Primary Outcomes

Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)

Time Frame: Pre-dose and +120 minutes

Secondary Outcomes

The maximum increase in SGaw from baseline over two hours(Baseline through +120 minutes)
The area-under-the-effect curve of change in SGaw from basline over time(Pre-dose and +120 minutes)
Time in hours to the maximum increase in SGaw from baseline(Baseline through +120 minutes post-dose)