Change in Airway Responsiveness After Allergen Exposure

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Saskatchewan
Information provided by (Responsible Party):
University of Saskatchewan Identifier:
First received: October 1, 2012
Last updated: December 10, 2013
Last verified: October 2013

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 Intervention
Allergic Asthma
Drug: Mannitol
Drug: Methacholine Chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity

Resource links provided by NLM:

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Change from baseline in airway responsiveness three hours after allergen exposure [ Time Frame: Change from Baseline at 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Provocholine


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01699594

Contact: Beth Davis, PhD. 306-966-8291

Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Beth Davis, PhD    306-966-8291   
Contact: Beth         
Principal Investigator: Donald W Cockcroft, MD         
Sub-Investigator: Beth Davis, PhD         
Sponsors and Collaborators
University of Saskatchewan
Principal Investigator: Donald W Cockcroft, MD University of Saskatchewan
  More Information

No publications provided by University of Saskatchewan

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Saskatchewan Identifier: NCT01699594     History of Changes
Other Study ID Numbers: IIS-A-524, BioReb #10-227
Study First Received: October 1, 2012
Last Updated: December 10, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Saskatchewan:

Additional relevant MeSH terms:
Methacholine Chloride
Autonomic Agents
Bronchoconstrictor Agents
Cardiovascular Agents
Cholinergic Agents
Cholinergic Agonists
Diuretics, Osmotic
Molecular Mechanisms of Pharmacological Action
Muscarinic Agonists
Natriuretic Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on March 30, 2015