Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model
NCT ID: NCT01204060
Last Updated: 2012-11-01
Study Results
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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UNKNOWN
NA
20 participants
INTERVENTIONAL
2010-09-30
2013-09-30
Brief Summary
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The objective of this project is to find out how the changes in the lung develop in severe asthma. Once this is known then new treatments can be developed to prevent irreversible damage to the lungs.
Volunteers will have substances sprayed up their nose and then samples collected from their nose. Levels of proteins and cells can be measured in these samples. This will give an indication of the type of inflammation that occurs.
The usual method of investigating the changes that occur in asthma is to challenge the lungs. Samples have to then be collected from the lungs. This can be in the form of sputum which must be treated to break it down to a liquid or washed out during a camera test. These methods cause problems with measuring proteins and they are broken down or diluted. Because the nose is easily accessible samples can be obtained at many time points. Because the samples can be collected directly from the nose the problems with obtaining samples from the lung are avoided.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Nasal allergen challenge
Nasal allergen challenge
Subjects will receive a nasal spray containing an allergen to which they are allergic
Nasal placebo challenge
Nasal placebo challenge
Subjects will receive a nasal spray with allergen diluent
Interventions
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Nasal allergen challenge
Subjects will receive a nasal spray containing an allergen to which they are allergic
Nasal placebo challenge
Subjects will receive a nasal spray with allergen diluent
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Subjects with a TNSS\> 2 at screening
3. Subjects with a structural nasal abnormality or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
4. Subjects who are a current smoker or have a history of smoking within the previous 3 months.
5. Subjects who have used a medication that could affect responses to nasal challenge (eg corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
6. Subjects who have participated in any other clinical trials within the previous 3 months.
\-
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Helen Neighbour, MB BS PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Melanie Kjarsgaard, BSc RRT
Role: primary
Other Identifiers
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#10-3322
Identifier Type: -
Identifier Source: org_study_id