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

This study is currently recruiting participants.
Verified October 2012 by McMaster University
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01204060
First received: September 15, 2010
Last updated: October 31, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Asthma
 Other: Nasal allergen challenge
Other: Nasal placebo challenge

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Level of eosinophils in nasal lavage [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in level of IL-4, IL-5 and IL-13 in nasal secretions [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
  • Change in nasal symptom score [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]
  • Change in FIZZ1 levels in nasal tissue [ Time Frame: Assessed 4 hours after challenge ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204060

Contacts
Contact: Melanie Kjarsgaard, BSc RRT 905 522 1155 ext 33024 mkarsga@stjoes.ca

Locations
Canada, Ontario
St Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Melanie Kjarsgaard, BSc RRT     905 522 1155 ext 33024     mkjarga@stjoes.ca    
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Investigators
Principal Investigator: Helen Neighbour, MB BS PhD McMaster University
  More Information

No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01204060     History of Changes
Other Study ID Numbers: #10-3322
Study First Received: September 15, 2010
Last Updated: October 31, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Nasal Allergen Lipopolysaccharide Inflammation Asthma

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013