Clinical Trial: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
Brief Summary: The purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: Increase in PD20 (provocative dose that reduce forced expiratory volume at one second (FEV1) by 20%) [ Time Frame: Baseline and 30 minutes after treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in systolic and diastolic blood pressure [ Time Frame: Baseline, 30 and 60 min after treatment ]
- Change from baseline in heart rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
- Change from baseline in respiratory rate [ Time Frame: Baseline, 30 and 60 min after treatment ]
- Occurrence of adverse events [ Time Frame: up to 8 days ]
- SaO2 (oxygen saturation) during metacholine challenge [ Time Frame: continuously after adminstration of study drug ]
Original Secondary Outcome: Same as current
Information By: Boehringer Ingelheim
Dates:
Date Received: July 3, 2014
Date Started: May 1998
Date Completion:
Last Updated: July 7, 2014
Last Verified: July 2014
