Certain lung disease medications can influence diagnostic tests and research investigations. This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines...
Date First Received: January 18, 2008
Last Updated: January 6, 2009
Verified by: University of Saskatchewan, July 2008
Clinical Trial Phase: Phase 4 | Start Date: January 2008
Overall Status: Completed
Estimated Enrollment: 12
Brief Summary
Official Title: “Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness”
Condition Keyword(s):
Intervention(s):
Certain lung disease medications can influence diagnostic tests and research investigations.
This study will investigate how long ipratropium bromide must be withheld before a methacholine challenge test can be conducted. This information will be useful for validating current guidelines.
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Study Primary Completion Date: April 2008
Intervention(s) in this Clinical Trial
- Drug: ipratropium bromide
- 2 puffs (40 micrograms) 2 puffs (0micrograms)
- Drug: placebo
- Matched placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- methacholine PC20
- Time Frame: 6hours and 12 hours post inhalation
Safety Issue?: No
- Time Frame: 6hours and 12 hours post inhalation
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of asthma; stable and controlled
- FEV1 greater than or equal to 65% predicted
Exclusion Criteria:
- Concomitant lung disease other than asthma
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Saskatchewan
Overall Clinical Trial Officials and Contacts
Donald W Cockcroft, MD Principal Investigator Department of Medicine University of Saskatchewan
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00605410
Study ID Number: BIO 07-161
ClinicalTrials.gov Identifier: NCT00605410
Health Authority: Canada: Health Canada
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