Change in Airway Responsiveness After Allergen Exposure

NCT ID: NCT01699594

Last Updated: 2015-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mannitol

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

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)

Methacholine Chloride

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

Group Type ACTIVE_COMPARATOR

Methacholine Chloride

Intervention Type DRUG

Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)

Interventions

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Mannitol

Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)

Intervention Type DRUG

Methacholine Chloride

Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)

Intervention Type DRUG

Other Intervention Names

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Aridol Provocholine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald W Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23987192 (View on PubMed)

Other Identifiers

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BioReb #10-227

Identifier Type: OTHER

Identifier Source: secondary_id

IIS-A-524

Identifier Type: -

Identifier Source: org_study_id

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