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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Omaha, Nebraska, 68131 United States
Contact
1-800-718-1021
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

- Significant concomitant disease or medications.

- Symptoms of allergic rhinitis within 2 weeks prior to screening.

NCT00562120
Pfizer
Completed
A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge

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[email protected]

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A Study to Test a New Decongestant in Patients With Allergic Rhinitis Following a Nasal Allergen Challenge
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Rhinitis
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00562120
A8801003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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