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Completed

NCT Number: NCT01064726

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.

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen

Drug

800 mg oral

Fluticasone propionate

Drug

200 mcg intra-nasal

Placebo

Drug

Placebo

Primary outcomes

  1. Nasal inflammatory markers

    Time frame: 8h 45 min post dose

  2. Acoustic rhinometry

    Time frame: 8h 45 min post dose

  3. Nasal symptom scores

    Time frame: 8h 45 min post dose

Secondary outcomes

  1. Spirometry

    Time frame: 8h 45 min post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 8, 2010
Registry last updated
Jun 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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