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.

Allergic Rhinitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064726
• Other study ID #: A9011065
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2009
• Last updated: June 1, 2010
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Ibuprofen
800 mg oral
• Fluticasone propionate
200 mcg intra-nasal
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal inflammatory markers		8h 45 min post dose	No
Primary	Acoustic rhinometry		8h 45 min post dose	No
Primary	Nasal symptom scores		8h 45 min post dose	No
Secondary	Spirometry		8h 45 min post dose	Yes

External Links

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