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Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI Versus Albuterol-HFA-MDI in Asthmatics
This study has been completed.
Study NCT00530062   Information provided by Teva Global Respiratory Research LLC
First Received: September 14, 2007   Last Updated: September 28, 2009   History of Changes

September 14, 2007
September 28, 2009
January 2007
October 2008   (final data collection date for primary outcome measure)
The percent change in the area-under-the-effect curve from test day baseline FEV1 versus time [ Time Frame: Study Days 1 and 2 ] [ Designated as safety issue: No ]
Improvement in Lung function test over 2 hour period following single dose of investigational drug treatment [ Time Frame: For up to 2 hour post treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00530062 on ClinicalTrials.gov Archive Site
  • The maximum percent increase in FEV1 (%) from baseline within the scheduled first 30 minutes of spirometric evaluations post dose [ Time Frame: Study Days 1 and 2 ] [ Designated as safety issue: No ]
  • The maximum percent increase in FEV1 from baseline over 2 hours [ Time Frame: Study days 1 and 2 ] [ Designated as safety issue: No ]
  • The area-under-the-effect curve of change in FEV1 from test-day baseline versus time [ Time Frame: Study days 1 and 2 ] [ Designated as safety issue: No ]
Same as current
 
Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI Versus Albuterol-HFA-MDI in Asthmatics
Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

This is a research study designed to compare the single-dose effectiveness of albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to participate in this study.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Crossover Assignment
Asthma
  • Drug: Albuterol-HFA-MDI
  • Drug: Albuterol-HFA-BAI
  • Active Comparator: Albuterol Hydrofluoroalkane (HFA) Breath-Actuated Inhaler (BAI)
  • Active Comparator: Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
49
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or females aged 7-70 years old
  • Asthma of a minimum of 6 months duration
  • Patients who demonstrate poor inhalation/actuation coordination when evaluated with the AIM -Aerosol Inhalation Monitor.
  • Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
  • The reversibility (FEV1) of <70% following administration of the initial 90 mcg of albuterol
  • Ability to perform spirometry reproducibly
  • Ability to self-perform PEF determinations and report scores on diaries
  • Can tolerate withdrawal of applicable medications at screening
  • Otherwise healthy individuals
  • Non-smokers for at least two years

Exclusion Criteria:

  • Allergy or sensitivity to albuterol
  • Exposure to investigational drugs within 30 days prior to the screening visit
  • Continuous treatment with Beta-blockers, MAO inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
  • Treated with oral or injectable corticosteroids within the six weeks prior to the screening visit
  • Unstable dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil
  • Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
  • Hospitalization for acute exacerbation of asthma more than twice in past year
  • Treatment in an emergency room or hospitalization for asthmatic symptoms within three months prior to the screening visit
  • An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved three weeks prior to the screening visit
  • History and/or presence of any clinically significant non-asthmatic acute or chronic disease
  • Known or suspected substance abuse
  • Previous enrollment in an IVAX Research-sponsored Albuterol HFA asthma study
  • Other criteria apply
Both
7 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00530062
Clinical Study Leader, Teva Global Respiratory Research, LLC
IXR-404-04-167
Teva Global Respiratory Research LLC
 
Study Chair: Clinical Study Leader Teva Global Respiratory Research LLC
Teva Global Respiratory Research LLC
September 2009

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