Back to resultsA 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.
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Fluticasone propionate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
Eligibility Criteria
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Ibuprofen
Fluticasone propionate
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Nasal inflammatory markers
Acoustic rhinometry
Nasal symptom scores
Secondary Outcome Measures
Spirometry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01064726
Brief Title
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.
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 Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen
Arm Type
Experimental
Arm Title
Fluticasone propionate
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
800 mg oral
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Intervention Description
200 mcg intra-nasal
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Nasal inflammatory markers
Time Frame
8h 45 min post dose
Title
Acoustic rhinometry
Time Frame
8h 45 min post dose
Title
Nasal symptom scores
Time Frame
8h 45 min post dose
Secondary Outcome Measure Information:
Title
Spirometry
Time Frame
8h 45 min post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011065&StudyName=A%20Study%20To%20Explore%20The%20Effect%20On%20Inflammatory%20Markers%20After%20Nasal%20Allergen%20Challenge%20In%20Subjects%20With%20Seasonal%20Allergic%20Rhinitis%20And%20T
Description
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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.
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