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

This study has been completed.
Sponsor:
Information provided by:
Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00054964
First received: February 14, 2003
Last updated: December 12, 2011
Last verified: December 2011
History of Changes

February 14, 2003
December 12, 2011
March 2003
August 2003   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00054964 on ClinicalTrials.gov Archive Site
  • The area-under-the-effect curve of change in SGaw from basline over time [ Time Frame: Pre-dose and +120 minutes ] [ Designated as safety issue: No ]
  • The maximum increase in SGaw from baseline over two hours [ Time Frame: Baseline through +120 minutes ] [ Designated as safety issue: No ]
  • Time in hours to the maximum increase in SGaw from baseline [ Time Frame: Baseline through +120 minutes post-dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Albuterol HFA-BOI
    Albuterol HFA breath operated inhaler, 90 mcg/sprau
  • Drug: Albuterol HFA-MDI
    Albuterol HFA multi-dose inhaler
    Other Name: Proair HFA-MDI
  • Experimental: Albuterol HFA-BOI
    Intervention: Drug: Albuterol HFA-BOI
  • Active Comparator: Albuterol HFA-MDI
    Intervention: Drug: Albuterol HFA-MDI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2003
August 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054964
IXR-202-4-167
No
Teva Study Physician, Teva Pharmaceutials
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Principal Investigator: Harold Nelson, MD National Jewish Medical Center
Teva Branded Pharmaceutical Products, R&D Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP