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

NCT ID: NCT00562120

Last Updated: 2014-04-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Rhinitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Allegra

Group Type ACTIVE_COMPARATOR

Allegra

Intervention Type DRUG

A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.

Allegra-D

Group Type ACTIVE_COMPARATOR

Allegra-D

Intervention Type DRUG

A single oral dose of Allegra-D is dosed to subjects as an active comparator.

PF-03654746

Group Type EXPERIMENTAL

PF-03654746

Intervention Type DRUG

A single oral dose of PF-03654746 is the investigational drug being studied.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Allegra

A single oral dose of Allegra is dosed to subjects in combination with PF-03654746.

Intervention Type DRUG

Allegra-D

A single oral dose of Allegra-D is dosed to subjects as an active comparator.

Intervention Type DRUG

PF-03654746

A single oral dose of PF-03654746 is the investigational drug being studied.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A8801003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.