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.

June 1, 2010 updated by: Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nasal inflammatory markers
Time Frame: 8h 45 min post dose
8h 45 min post dose
Acoustic rhinometry
Time Frame: 8h 45 min post dose
8h 45 min post dose
Nasal symptom scores
Time Frame: 8h 45 min post dose
8h 45 min post dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Spirometry
Time Frame: 8h 45 min post dose
8h 45 min post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 2, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9011065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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