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.
Status and phase
Completed
Phase 1
Conditions
Allergic Rhinitis
Treatments
Drug: Placebo
Drug: Fluticasone propionate
Drug: Ibuprofen
Details and patient eligibility
About
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.
Enrollment
18 patients
Sex
All
Ages
19 to 55 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
18 participants in 3 patient groups, including a placebo group
Ibuprofen
Experimental group
Treatment:
Drug: Ibuprofen
Fluticasone propionate
Experimental group
Treatment:
Drug: Fluticasone propionate
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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