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Completed

NCT Number: NCT00054964

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Jewish Medical and Research Ceter

Denver, Colorado, 80206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albuterol HFA-BOI

Drug

Albuterol HFA breath operated inhaler, 90 mcg/sprau

Albuterol HFA-MDI

Drug

Albuterol HFA multi-dose inhaler

Other names: Proair HFA-MDI

Primary outcomes

  1. 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

  1. The area-under-the-effect curve of change in SGaw from basline over time

    Time frame: Pre-dose and +120 minutes

  2. The maximum increase in SGaw from baseline over two hours

    Time frame: Baseline through +120 minutes

  3. Time in hours to the maximum increase in SGaw from baseline

    Time frame: Baseline through +120 minutes post-dose

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Feb 17, 2003
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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