Back to resultsRepeat Nasal Allergen Challenge
Primary Purpose
Hayfever
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Skin Prick Test
Nasal allergen challenge
Nasal filter paper placement
Nasal lavage
Nasal scrape
Nasal symptoms score
Sponsored by
About this trial
This is an interventional diagnostic trial for Hayfever focused on measuring Nasal allergen challenge, Allergic rhinitis, Timothy grass pollen, inflammatory mediators
Eligibility Criteria
Inclusion Criteria: Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years. Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies. Exclusion Criteria: Smokers (use of tobacco products in the previous 3 months). Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 > 80% predicted at screening).
Sites / Locations
- National Heart & Lung Institute Clinical Studies Unit
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00290368
First Posted
February 10, 2006
Last Updated
September 13, 2023
Sponsor
Imperial College London
Collaborators
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00290368
Brief Title
Repeat Nasal Allergen Challenge
Official Title
Assessment of Inflammatory Mediator and Cellular Changes Following Repeated Nasal Allergen Challenge in Subjects With Allergic Rhinitis Sensitive to Timothy Grass Pollen - a Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Imperial College London
Collaborators
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.
Detailed Description
This is a non-drug, biomarker study to assess the utility of the model of repeated nasal allergen challenges in subjects with atopic rhinitis as a method of inducing an increased response to inhaled allergen, which will more closely resemble the responses seen during the hayfever season.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hayfever
Keywords
Nasal allergen challenge, Allergic rhinitis, Timothy grass pollen, inflammatory mediators
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Skin Prick Test
Intervention Type
Procedure
Intervention Name(s)
Nasal allergen challenge
Intervention Type
Procedure
Intervention Name(s)
Nasal filter paper placement
Intervention Type
Procedure
Intervention Name(s)
Nasal lavage
Intervention Type
Procedure
Intervention Name(s)
Nasal scrape
Intervention Type
Procedure
Intervention Name(s)
Nasal symptoms score
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with a history of seasonal (intermittent) atopic rhinitis, aged 18-40 years.
Otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.
Exclusion Criteria:
Smokers (use of tobacco products in the previous 3 months).
Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (FEV1 > 80% predicted at screening).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor T Hansel, FRCPath
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart & Lung Institute Clinical Studies Unit
City
London
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Repeat Nasal Allergen Challenge
We'll reach out to this number within 24 hrs