Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.|
- Level of eosinophils in nasal lavage [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
- Change in level of IL-4, IL-5 and IL-13 in nasal secretions [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
- Change in nasal symptom score [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
- Change in FIZZ1 levels in nasal tissue [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Nasal allergen challenge||
Other: Nasal allergen challenge
Subjects will receive a nasal spray containing an allergen to which they are allergic
|Placebo Comparator: Nasal placebo challenge||
Other: Nasal placebo challenge
Subjects will receive a nasal spray with allergen diluent
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204060
|St Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Helen Neighbour, MB BS PhD||McMaster University|