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

November 17, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Ceter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Albuterol HFA-BOI
Drug: Albuterol HFA-BOI
Albuterol HFA breath operated inhaler, 90 mcg/sprau
Active Comparator: Albuterol HFA-MDI
Drug: Albuterol HFA-MDI
Albuterol HFA multi-dose inhaler
Other Names:
  • Proair HFA-MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Pre-dose and +120 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

  • Principal Investigator: Harold Nelson, MD, National Jewish Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane breath-activated inhaler and Nelson HS, Wenzel SE, Weisfeld L, Llorens L, Atkinson DC, Stahl EG. Comparison of single-dose efficacy of albuterol-hydrofloroalkane metered-dose inhaler in asthma patients with poor inhaler coordinating ability. Chest 2008;134:92003S (Abstracts, ACCP Annual Meeting, October 25-30, 2008, Philadelphia, Pennsylvania, USA.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2003

Primary Completion (Actual)

August 31, 2003

Study Completion (Actual)

August 31, 2003

Study Registration Dates

First Submitted

February 14, 2003

First Submitted That Met QC Criteria

February 14, 2003

First Posted (Estimate)

February 17, 2003

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXR-202-4-167

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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