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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01064726
First received: September 21, 2009
Last updated: June 1, 2010
Last verified: June 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Acoustic rhinometry [ Time Frame: 8h 45 min post dose ] [ Designated as safety issue: No ]
  • Nasal symptom scores [ Time Frame: 8h 45 min post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spirometry [ Time Frame: 8h 45 min post dose ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01064726     History of Changes
Other Study ID Numbers: A9011065
Study First Received: September 21, 2009
Last Updated: June 1, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 29, 2014