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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal allergen challenge | Active Comparator |
| |
| Nasal placebo challenge | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal allergen challenge | Other | Subjects will receive a nasal spray containing an allergen to which they are allergic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of eosinophils in nasal lavage | Assessed 4 hours after challenge |
| 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 | |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melanie Kjarsgaard, BSc RRT | Contact | 905 522 1155 | 33024 | mkarsga@stjoes.ca |
| Name | Affiliation | Role |
|---|---|---|
| Helen Neighbour, MB BS PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Recruiting | Hamilton | Ontario | L8N 4A6 | Canada |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Nasal placebo challenge | Other | Subjects will receive a nasal spray with allergen diluent |
|
| Change in FIZZ1 levels in nasal tissue |
| Assessed 4 hours after challenge |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |