A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
NCT00562120
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- Male or female subjects 19-55 years with allergic rhinitis requiring treatment within the previous 2 years.
- Subjects that respond to a ragweed nasal allergen challenge at screening.
- History of asthma or FEV1 < 80% predicted.
- Significant concomitant disease or medications.
- Symptoms of allergic rhinitis within 2 weeks prior to screening.
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Descriptive Information | ||||
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Brief Title ICMJE | A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge | |||
Official Title ICMJE | A Randomized, Double Blind, Double Dummy, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of An H3 Receptor Antagonist (PF-03654746) On Congestion Following A Nasal Allergen Challenge In Subjects With Seasonal Allergic Rhinitis. | |||
Brief Summary | An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Allergic Rhinitis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 21 | |||
Original Estimated Enrollment ICMJE | 24 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00562120 | |||
Other Study ID Numbers ICMJE | A8801003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |