A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

NCT00562120

Last updated date
Study Location
Pfizer Investigational Site
Omaha, Nebraska, 68131, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Allergic Rhinitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
19-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: Placebo
    A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs.
  • Drug: Allegra
    A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.
  • Drug: Allegra-D
    A single oral dose of Allegra-D is dosed to subjects as an active comparator.
  • Drug: PF-03654746
    A single oral dose of PF-03654746 is the investigational drug being studied.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Allegra
    Intervention: Drug: Allegra
  • Active Comparator: Allegra-D
    Intervention: Drug: Allegra-D
  • Experimental: PF-03654746
    Intervention: Drug: PF-03654746
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
 (submitted: March 10, 2014)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2007)
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:

  • 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.

Exclusion Criteria:

  • History of asthma or FEV1 < 80% predicted.
  • Significant concomitant disease or medications.
  • Symptoms of allergic rhinitis within 2 weeks prior to screening.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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