Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness

Verified by: University of Saskatchewan, July 2008
First Received: January 18, 2008 | Last Updated: January 6, 2009 | Phase: Phase 4 | Start Date: January 2008
Overall Status: Completed | Estimated Enrollment: 12
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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...

Brief Summary

Official Title: “Duration of Protective Effect From Inhaled Ipratropium Bromide on Methacholine Airway Hyperresponsiveness”

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: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
  • 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

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 Investigator Information

Lead Investigator: University of Saskatchewan Other

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 February 09, 2012

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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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00605410