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.
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.
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 2, 2010
June 1, 2010
6 months
September 21, 2009
June 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Nasal inflammatory markers
8h 45 min post dose
Acoustic rhinometry
8h 45 min post dose
Nasal symptom scores
8h 45 min post dose
Secondary Outcomes (1)
Spirometry
8h 45 min post dose
Study Arms (3)
Ibuprofen
EXPERIMENTALFluticasone propionate
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects with seasonal allergic rhinitis (out of season).
- Sensitive to ragweed skin prick test and screening nasal allergen challenge.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
Omaha, Nebraska, 68131, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 21, 2009
First Posted
February 8, 2010
Study Start
October 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 2, 2010
Record last verified: 2010-06