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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204060
• Other study ID #: #10-3322
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2010
• Last updated: October 31, 2012
• Start date: September 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2012
• Source: McMaster University
• Contact: Melanie Kjarsgaard, BSc RRT
• Phone: 905 522 1155
• Email: mkarsga[@]stjoes.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	St Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of eosinophils in nasal lavage		Assessed 4 hours after challenge	No
Secondary	Change in level of IL-4, IL-5 and IL-13 in nasal secretions		Assessed 4 hours after challenge	No
Secondary	Change in nasal symptom score		Assessed 4 hours after challenge	No
Secondary	Change in FIZZ1 levels in nasal tissue		Assessed 4 hours after challenge	No