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NCT00483353 Clinical Trial

Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00483353
Other study ID # A9011058
Secondary ID
Status Completed
Phase Phase 1
First received June 5, 2007
Last updated June 12, 2008
Start date July 2007

Study information
Verified date June 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Intra-nasal allergen challenge with Phleum pratense.

• Collection of nasal effluent using filter paper.

• Measurement of nasal congestion using acoustic rhinometry.

Locations
Country Name City State
United Kingdom Pfizer Investigational Site London England

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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.
See also
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