Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 5, 2007
Last updated: June 12, 2008
Last verified: June 2008
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.

Condition Intervention Phase
Seasonal Allergic Rhinitis
Procedure: Intra-nasal allergen challenge with Phleum pratense.
Procedure: Collection of nasal effluent using filter paper.
Procedure: Measurement of nasal congestion using acoustic rhinometry.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis

Resource links provided by NLM:

Further study details as provided by Pfizer:

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.

Estimated Enrollment: 6
Study Start Date: July 2007

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00483353

United Kingdom
Pfizer Investigational Site
London, England, United Kingdom, SW3 6HP
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00483353     History of Changes
Other Study ID Numbers: A9011058 
Study First Received: June 5, 2007
Last Updated: June 12, 2008
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 02, 2016