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

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

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 Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Other: Nasal allergen challenge; Other: Nasal placebo challenge

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St Joseph's Healthcare Hamilton
      • Contact: Melanie Kjarsgaard, BSc RRT; Phone Number: 33024 905 522 1155; Email: mkjarga@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Helen Neighbour, MB BS PhD, McMaster University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: September 15, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Estimate): November 1, 2012
• Last Update Submitted That Met QC Criteria: October 31, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Nasal Allergen Lipopolysaccharide Inflammation Asthma
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: #10-3322