Change in Airway Responsiveness After Allergen Exposure

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01699594
First received: October 1, 2012
Last updated: December 10, 2013
Last verified: October 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01699594

Contacts
Contact: Beth Davis, PhD. 306-966-8291 beth.davis@usask.ca

Locations
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Beth Davis, PhD    306-966-8291    beth.davis@usask.ca   
Contact: Beth         
Principal Investigator: Donald W Cockcroft, MD         
Sub-Investigator: Beth Davis, PhD         
Sponsors and Collaborators
University of Saskatchewan
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Saskatchewan
ClinicalTrials.gov 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:
asthma
allergies
mannitol
methacholine

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mannitol
Methacholine Chloride
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014