Clincosm LogoSign in Get a demo

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

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00054964
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
5
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Albuterol HFA-BOI
  • Drug: Albuterol HFA-MDI
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Actual Study Start Date :
Mar 31, 2003
Actual Primary Completion Date :
Aug 31, 2003
Actual Study Completion Date :
Aug 31, 2003

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. The area-under-the-effect curve of change in SGaw from basline over time [Pre-dose and +120 minutes]

    2. The maximum increase in SGaw from baseline over two hours [Baseline through +120 minutes]

    3. Time in hours to the maximum increase in SGaw from baseline [Baseline through +120 minutes post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Jewish Medical and Research Ceter Denver Colorado United States 80206

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT00054964
    Other Study ID Numbers:
    • IXR-202-4-167
    First Posted:
    Feb 17, 2003
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Asthma
    Albuterol

    Study Results

    No Results Posted as of Nov 30, 2021