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.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01064726

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Ibuprofen Drug: Fluticasone propionate Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double Blind (3rd Party Open), 3-Way Crossover Study To Explore The Reproducibility Of Inflammatory Markers After Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis (Out Of Season) And The Effect Of A Single Dose Of Ibuprofen Or Fluticasone Propionate On The Allergen Response.

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibuprofen	Drug: Ibuprofen 800 mg oral
Experimental: Fluticasone propionate	Drug: Fluticasone propionate 200 mcg intra-nasal
Placebo Comparator: Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: Ibuprofen

Drug: Ibuprofen

800 mg oral

Experimental: Fluticasone propionate

Drug: Fluticasone propionate

200 mcg intra-nasal

Placebo Comparator: Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

Spirometry [8h 45 min post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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.