Back to resultsEffect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Intra-nasal allergen challenge with Phleum pratense.
Collection of nasal effluent using filter paper.
Measurement of nasal congestion using acoustic rhinometry.
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.
Exclusion Criteria:
- Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Secondary Outcome Measures
Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483353
Brief Title
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
Official Title
A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intra-nasal allergen challenge with Phleum pratense.
Intervention Type
Procedure
Intervention Name(s)
Collection of nasal effluent using filter paper.
Intervention Type
Procedure
Intervention Name(s)
Measurement of nasal congestion using acoustic rhinometry.
Primary Outcome Measure Information:
Title
Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Secondary Outcome Measure Information:
Title
Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.
Exclusion Criteria:
Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
London
State/Province
England
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011058&StudyName=Effect%20of%20a%20nasal%20bolus%20allergen%20challenge%20on%20inflammatory%20markers%20
Description
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Learn more about this trial
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
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