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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.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064726
First Posted: February 8, 2010
Last Update Posted: June 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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.

Condition Intervention Phase
Allergic Rhinitis Drug: Ibuprofen Drug: Fluticasone propionate Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Nasal inflammatory markers [ Time Frame: 8h 45 min post dose ]
  • Acoustic rhinometry [ Time Frame: 8h 45 min post dose ]
  • Nasal symptom scores [ Time Frame: 8h 45 min post dose ]

Secondary Outcome Measures:
  • Spirometry [ Time Frame: 8h 45 min post dose ]

Enrollment: 18
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ibuprofen Drug: Ibuprofen
800 mg oral
Experimental: Fluticasone propionate Drug: Fluticasone propionate
200 mcg intra-nasal
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064726


Locations
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01064726     History of Changes
Other Study ID Numbers: A9011065
First Submitted: September 21, 2009
First Posted: February 8, 2010
Last Update Posted: June 2, 2010
Last Verified: June 2010

Keywords provided by Pfizer:
Allergic Rhinitis Nasal Allergen Challenge Inflammatory Markers

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Ibuprofen
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action