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NCT00605410 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00605410
Other study ID # BIO 07-161
Secondary ID
Status Completed
Phase Phase 4
First received January 18, 2008
Last updated January 6, 2009
Start date January 2008
Est. completion date April 2008

Study information
Verified date July 2008
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date April 2008
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of asthma; stable and controlled

- FEV1 greater than or equal to 65% predicted

Exclusion Criteria:

- Concomitant lung disease other than asthma

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• ipratropium bromide
2 puffs (40 micrograms) 2 puffs (0micrograms)
• placebo
Matched placebo

Locations
Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (2)
Lead Sponsor Collaborator
University of Saskatchewan Royal University Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary methacholine PC20 6hours and 12 hours post inhalation No
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