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.

NCT ID: NCT01064726

Last Updated: 2010-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ibuprofen

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

800 mg oral

Fluticasone propionate

Group Type EXPERIMENTAL

Fluticasone propionate

Intervention Type DRUG

200 mcg intra-nasal

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Ibuprofen

800 mg oral

Intervention Type DRUG

Fluticasone propionate

200 mcg intra-nasal

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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A9011065

Identifier Type: -

Identifier Source: org_study_id

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