A Study To Explore The Effect On Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.
Phase 1
Completed
- Conditions
- Allergic Rhinitis
- Interventions
- Registration Number
- NCT01064726
- Lead Sponsor
- Pfizer
- Brief Summary
After a nasal allergen challenge it should be possible to measure markers of inflammation that may be useful to assess the properties of future drugs. If these markers are reproducible and impacted by the study drugs they could be useful for future drug development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Male or female subjects with seasonal allergic rhinitis (out of season).
- Sensitive to ragweed skin prick test and screening nasal allergen challenge.
Exclusion Criteria
- Subjects with significant concomitant diseases.
- Subjects with symptoms of allergic rhinitis in 2 weeks prior to screening.
- Female subjects that are pregnant or nursing. Subjects with hypersensitivity to study drugs or allergen challenge.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo - Fluticasone propionate Fluticasone propionate - Ibuprofen Ibuprofen -
- Primary Outcome Measures
Name Time Method Nasal inflammatory markers 8h 45 min post dose Acoustic rhinometry 8h 45 min post dose Nasal symptom scores 8h 45 min post dose
- Secondary Outcome Measures
Name Time Method Spirometry 8h 45 min post dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Omaha, Nebraska, United States