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Comparison of Single-Dose of Albuterol Breath Activated Inhaler Versus Albuterol Metered Dose Inhaler in Asthmatics

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ClinicalTrials.gov Identifier: NCT00530062
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Tracking Information
First Submitted Date  ICMJE September 14, 2007
First Posted Date  ICMJE September 17, 2007
Last Update Posted Date January 12, 2018
Study Start Date  ICMJE January 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
The percent change in the area-under-the-effect curve from test day baseline FEV1 versus time [ Time Frame: Baseline to two hours post dose, Study Days 1 and 2 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00530062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
  • The maximum percent increase in FEV1 (%) from baseline within the scheduled first 30 minutes of spirometric evaluations post dose [ Time Frame: Baseline to thirty minutes post dose, Study Days 1 and 2 ]
  • The maximum percent increase in FEV1 from baseline over 2 hours [ Time Frame: Baseline to two hours post dose, Study days 1 and 2 ]
  • The area-under-the-effect curve of change in FEV1 from test-day baseline versus time [ Time Frame: Baseline to two hours post dose, Study days 1 and 2 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Single-Dose of Albuterol Breath Activated Inhaler Versus Albuterol Metered Dose Inhaler in Asthmatics
Official Title  ICMJE Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Albuterol-HFA-MDI
    Inhalation Aerosols, 90 mcg, 1 dose per treatment period
    Other Names:
    • Albuterol
    • ProAir
  • Drug: Albuterol-HFA-BAI
    Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
    Other Name: Albuterol
Study Arms  ICMJE
  • Active Comparator: Albuterol HFA-BAI
    Albuterol Hydrofluoroalkane (HFA) Breath-Actuated Inhaler (BAI)
    Intervention: Drug: Albuterol-HFA-BAI
  • Active Comparator: Albuterol HFA-MDI
    Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
    Intervention: Drug: Albuterol-HFA-MDI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2009)
49
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2007)
40
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530062
Other Study ID Numbers  ICMJE IXR-404-04-167
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Study Sponsor  ICMJE Teva Branded Pharmaceutical Products, R&D Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Clinical Study Leader Teva Branded Pharmaceutical Products, R&D Inc.
PRS Account Teva Pharmaceutical Industries
Verification Date January 2018

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