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Change in Airway Responsiveness After Allergen Exposure

Sponsor
University of Saskatchewan (Other)
Overall Status
Completed
CT.gov ID
NCT01699594
Collaborator
(none)
11
Enrollment
1
Location
2
Arms
19
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mannitol

This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.

Drug: Mannitol
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Other Names:
  • Aridol

    		•
    Active Comparator: Methacholine Chloride

    This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.

    Drug: Methacholine Chloride
    Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
    Other Names:
  • Provocholine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in airway responsiveness three hours after allergen exposure [Change from Baseline at 3 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Saskatchewan Saskatoon Saskatchewan Canada S7N 0W8

    Sponsors and Collaborators

    • University of Saskatchewan

    Investigators

    • Principal Investigator: Donald W Cockcroft, MD, University of Saskatchewan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Saskatchewan
    ClinicalTrials.gov Identifier:
    NCT01699594
    Other Study ID Numbers:
    • IIS-A-524
    • BioReb #10-227
    First Posted:
    Oct 3, 2012
    Last Update Posted:
    Apr 9, 2015
    Last Verified:
    Oct 1, 2013
    Keywords provided by University of Saskatchewan
    asthma
    allergies
    mannitol
    methacholine
    Additional relevant MeSH terms:
    Asthma
    Mannitol
    Methacholine Chloride

    Study Results

    No Results Posted as of Apr 9, 2015