Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model

Study Overview
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Brief Summary
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Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can result in reduced quality of life and difficulties with work and school. Once the disease has become established with irreversible changes in the lungs it can be very difficult to treat. Severe asthma although less common than mild asthma uses more healthcare resources. 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.

Official Title
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Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.

Conditions
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Asthma

Intervention / Treatment
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* Other: Nasal allergen challenge
* Other: Nasal placebo challenge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 Subjects over the age of 18 2 Subjects able to give written informed consent 3 Subjects able to comply with study procedures and protocol 4 Subjects with a history of allergic asthma 5 Subjects with a positive skin prick test to a common aeroallergen 6 Subjects who are otherwise healthy with no other health problems Exclusion Criteria: Subjects with a viral URTI within 2 weeks prior to screening. Subjects with a TNSS> 2 at screening Subjects with a structural nasal abnormality or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months. Subjects who are a current smoker or have a history of smoking within the previous 3 months. 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. Subjects who have participated in any other clinical trials within the previous 3 months. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal allergen challenge<br> | Other: Nasal allergen challenge<br>* Subjects will receive a nasal spray containing an allergen to which they are allergic<br>|
| Placebo Comparator: Nasal placebo challenge<br> | Other: Nasal placebo challenge<br>* Subjects will receive a nasal spray with allergen diluent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of eosinophils in nasal lavage |  | Assessed 4 hours after challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of IL-4, IL-5 and IL-13 in nasal secretions |  | Assessed 4 hours after challenge | 
| Change in nasal symptom score |  | Assessed 4 hours after challenge | 
| Change in FIZZ1 levels in nasal tissue |  | Assessed 4 hours after challenge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal Allergen Lipopolysaccharide Inflammation Asthma