Change in Airway Responsiveness After Allergen Exposure
Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
2 other identifiers
interventional
11
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedApril 9, 2015
October 1, 2013
1.6 years
October 1, 2012
April 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in airway responsiveness three hours after allergen exposure
Change from Baseline at 3 hours
Study Arms (2)
Mannitol
EXPERIMENTALThis arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.
Methacholine Chloride
ACTIVE COMPARATORThis arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.
Interventions
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
Eligibility Criteria
You may qualify if:
- mild, allergic asthma
- FEV1 greater than 70% predicted
- methacholine PC20 less than or equal to 16mg/ml
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8, Canada
Related Publications (1)
Amakye DO, Davis BE, Martin AL, Peters GE, Cockcroft DW. Refractoriness to inhaled mannitol 3 hours after allergen challenge. Ann Allergy Asthma Immunol. 2013 Sep;111(3):182-4. doi: 10.1016/j.anai.2013.06.011. Epub 2013 Jul 12.
PMID: 23987192DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald W Cockcroft, MD
University of Saskatchewan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 3, 2012
Study Start
October 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 9, 2015
Record last verified: 2013-10