Change in Airway Responsiveness After Allergen Exposure

Allergic Asthma Clinical Trial

Official title:

Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699594
• Other study ID #: IIS-A-524
• Secondary ID: BioReb #10-227
• Status: Completed
• Phase: N/A
• First received: October 1, 2012
• Last updated: April 8, 2015
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: October 2013
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Asthma

Intervention

Drug:
• Mannitol
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
• Methacholine Chloride
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in airway responsiveness three hours after allergen exposure		Change from Baseline at 3 hours	No