Recruiting

Allergen Challenge

Sponsor:

McMaster University

Code:

NCT01204060

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nasal allergen challenge

Nasal placebo challenge

Study Details

Brief summary:

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.

Conditions

Asthma

Study ID

NCT01204060

Start date

Sep, 2010

Status verified date

Oct, 2012

Completion date

Sep, 2013

Anticipated

Primary completion date

Sep, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

1. Subjects with a viral URTI within 2 weeks prior to screening.
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.

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Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Nasal allergen challenge

placebo comparator: Nasal placebo challenge

Interventions

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

Primary outcome measure

  • Level of eosinophils in nasal lavage [ Time Frame: Assessed 4 hours after challenge ]

Central Contacts and Locations

Central contacts

Melanie Kjarsgaard, BSc RRT

905 522 1155mkarsga@stjoes.ca

Locations

St Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

Melanie Kjarsgaard, BSc RRT

905 522 1155mkjarga@stjoes.ca

More Information

Sponsor

McMaster University

Last update posted

Nov 1, 2012

Last verified

Oct, 2012

Keywords

  • Nasal Allergen Lipopolysaccharide Inflammation Asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2012-11-01.