Clinical Trial: Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-Dose Efficacy Comparison of Albuterol Hydrofluoroalkane (HFA) Breath-operated Inhaler (BOI) (Volare Easi-Breathe™) and Albuterol HFA Meter Dose Inhaler (MDI) (Volare™) in Adolesce

Brief Summary: This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.

Detailed Summary:
Sponsor: Teva Branded Pharmaceutical Products, R&D Inc.

Current Primary Outcome: The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge. [ Time Frame: Three doses 2-7 days apart ]

Original Primary Outcome:

Current Secondary Outcome:

  • Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean percent change in the baseline absolute FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean absolute change in the baseline absolute FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean percent change in the baseline percent-predicted FEV1 value at each post-challenge time point [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean largest negative (or mean smallest positive) percent change in the baseline absolute FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Mean largest negative (or mean smallest positive) percent change in the average test-day pre-dose baseline percent predicted FEV1 value observed up to one hour post-challenge [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Time to recovery (in minutes) measured from time of completion of exercise challenge to time FEV1 returns to 10% or less of baseline value during the recovery phase [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Total changes in FEV1 expressed as the baseline-adjusted area-under-the-effect curve of the percent-predicted FEV1 versus time over 60 minutes (AUEC0 60) [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]
  • Percentage of patients who are "protected" (maximum percent decrease in the baseline absolute FEV1 <10%), "partially protected" (10 20%), and "unprotected" (>20%). [ Time Frame: exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes ]


Original Secondary Outcome:

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: June 14, 2004
Date Started: June 2004
Date Completion:
Last Updated: March 19, 2015
Last Verified: March 2015