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

NCT01204060 | Unknown

• 1 other identifier: #10-3322
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Nasal Allergen Lipopolysaccharide Inflammation Asthma

Outcome Measures

Primary Outcomes (1)

• Level of eosinophils in nasal lavage

  Assessed 4 hours after challenge

Secondary Outcomes (3)

• 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

Study Arms (2)

Nasal allergen challenge

ACTIVE COMPARATOR

Other: Nasal allergen challenge

Nasal placebo challenge

PLACEBO COMPARATOR

Other: Nasal placebo challenge

Interventions

Nasal allergen challenge OTHER

Subjects will receive a nasal spray containing an allergen to which they are allergic

Nasal allergen challenge

Nasal placebo challenge OTHER

Subjects will receive a nasal spray with allergen diluent

Nasal placebo challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Helen Neighbour, MB BS PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Kjarsgaard, BSc RRT

CONTACT

905 522 1155; mkarsga@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

CA (1)