Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Albuterol HFA-MDI; Drug: Albuterol HFA-BOI

• Registration Number: NCT00054964
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

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.

Study Timeline

• Study First Submitted: 2003-02-14
• Study First Submitted QC: 2003-02-14
• Study First Posted: 2003-02-17
• Study Start: 2003-03-31
• Primary Completion: 2003-08-31
• Study Completion: 2003-08-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-17
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Albuterol HFA-MDI	Albuterol HFA-MDI	-
Albuterol HFA-BOI	Albuterol HFA-BOI	-

Primary Outcome Measures

Name	Time	Method
Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)	Pre-dose and +120 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Jewish Medical and Research Ceter; 🇺🇸 Denver, Colorado, United States