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Change in Airway Responsiveness After Allergen Exposure

Primary Purpose

Allergic Asthma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mannitol
Methacholine Chloride
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Allergic Asthma focused on measuring asthma, allergies, mannitol, methacholine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mannitol

Methacholine Chloride

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in airway responsiveness three hours after allergen exposure

Secondary Outcome Measures

Full Information

First Posted
October 1, 2012
Last Updated
April 8, 2015
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT01699594
Brief Title
Change in Airway Responsiveness After Allergen Exposure
Official Title
Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
asthma, allergies, mannitol, methacholine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mannitol
Arm Type
Experimental
Arm Description
This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.
Arm Title
Methacholine Chloride
Arm Type
Active Comparator
Arm Description
This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.
Intervention Type
Drug
Intervention Name(s)
Mannitol
Other Intervention Name(s)
Aridol
Intervention Description
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Intervention Type
Drug
Intervention Name(s)
Methacholine Chloride
Other Intervention Name(s)
Provocholine
Intervention Description
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
Primary Outcome Measure Information:
Title
Change from baseline in airway responsiveness three hours after allergen exposure
Time Frame
Change from Baseline at 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald W Cockcroft, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23987192
Citation
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.
Results Reference
derived

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Change in Airway Responsiveness After Allergen Exposure

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