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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01699594
Other study ID # IIS-A-524
Secondary ID BioReb #10-227
Status Completed
Phase N/A
First received October 1, 2012
Last updated April 8, 2015
Start date October 2012
Est. completion date May 2014

Study information

Verified date October 2013
Source University of Saskatchewan
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Exposure to allergens changes the way the airway responds to some stimuli (methacholine). The investigators will look at whether or not exposure to allergens changes the way the airway responds to a different stimuli (mannitol) and compare that with the known stimuli (methacholine).


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- mild, allergic asthma

- FEV1 greater than 70% predicted

- methacholine PC20 less than or equal to 16mg/ml

Exclusion Criteria:

- known sensitivity to mannitol or other excipient

- diagnosis of any other respiratory or non respiratory disease/disorder that would preclude the individual from participating

- recent thoracic, abdominal or eye surgery

- recent allergen exposure (4 weeks), respiratory infection (6 weeks)

- current immunotherapy

- pregnancy

- history of anaphylaxis

- use of asthma therapies other than short acting beta agonist

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Mannitol
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Methacholine Chloride
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)

Locations

Country Name City State
Canada University of Saskatchewan Saskatoon Saskatchewan

Sponsors (1)

Lead Sponsor Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in airway responsiveness three hours after allergen exposure Change from Baseline at 3 hours No
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