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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01064726

Enrollment

Registered

2010-02-08

Start date

2009-10-31

Completion date

2010-04-30

Last updated

2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers

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.

Interventions

DRUGIbuprofen

800 mg oral

DRUGFluticasone propionate

200 mcg intra-nasal

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Nasal inflammatory markers	8h 45 min post dose
Acoustic rhinometry	8h 45 min post dose
Nasal symptom scores	8h 45 min post dose

Secondary

Measure	Time frame
Spirometry	8h 45 min post dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026