- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699594
Change in Airway Responsiveness After Allergen Exposure
April 8, 2015 updated by: University of Saskatchewan
Allergen Induced Increase in Indirect Non-allergic Bronchial Reactivity
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- University of Saskatchewan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mannitol
This arm will assess the allergen induced change in airway responsiveness to mannitol bronchoprovocation.
|
Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
Other Names:
|
ACTIVE_COMPARATOR: Methacholine Chloride
This arm will assess the allergen induced change in airway responsiveness to methacholine bronchoprovocation.
|
Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in airway responsiveness three hours after allergen exposure
Time Frame: Change from Baseline at 3 hours
|
Change from Baseline at 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
May 1, 2014
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
October 1, 2012
First Submitted That Met QC Criteria
October 1, 2012
First Posted (ESTIMATE)
October 3, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 8, 2015
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Cholinergic Agonists
- Respiratory System Agents
- Miotics
- Parasympathomimetics
- Bronchoconstrictor Agents
- Muscarinic Agonists
- Mannitol
- Methacholine Chloride
Other Study ID Numbers
- IIS-A-524
- BioReb #10-227 (OTHER: University of Saskatchewan)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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