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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nasal allergen challenge
Nasal placebo challenge
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Nasal Allergen Lipopolysaccharide Inflammation Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • St Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nasal allergen challenge

Nasal placebo challenge

Arm Description

Outcomes

Primary Outcome Measures

Level of eosinophils in nasal lavage

Secondary Outcome Measures

Change in level of IL-4, IL-5 and IL-13 in nasal secretions
Change in nasal symptom score
Change in FIZZ1 levels in nasal tissue

Full Information

First Posted
September 15, 2010
Last Updated
October 31, 2012
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT01204060
Brief Title
Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model
Official Title
Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Nasal Allergen Lipopolysaccharide Inflammation Asthma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal allergen challenge
Arm Type
Active Comparator
Arm Title
Nasal placebo challenge
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Nasal allergen challenge
Intervention Description
Subjects will receive a nasal spray containing an allergen to which they are allergic
Intervention Type
Other
Intervention Name(s)
Nasal placebo challenge
Intervention Description
Subjects will receive a nasal spray with allergen diluent
Primary Outcome Measure Information:
Title
Level of eosinophils in nasal lavage
Time Frame
Assessed 4 hours after challenge
Secondary Outcome Measure Information:
Title
Change in level of IL-4, IL-5 and IL-13 in nasal secretions
Time Frame
Assessed 4 hours after challenge
Title
Change in nasal symptom score
Time Frame
Assessed 4 hours after challenge
Title
Change in FIZZ1 levels in nasal tissue
Time Frame
Assessed 4 hours after challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Kjarsgaard, BSc RRT
Phone
905 522 1155
Ext
33024
Email
mkarsga@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Neighbour, MB BS PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Kjarsgaard, BSc RRT
Phone
905 522 1155
Ext
33024
Email
mkjarga@stjoes.ca

12. IPD Sharing Statement

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

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