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The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

PF-03654764

Allegra

PF-03654764

Allegra-D

Placebo

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic rhinitis Environmental exposure unit

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects 18-60 years allergic to ragweed pollen.
Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit.

Exclusion Criteria:

Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764.
Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

PF-03654764 + Allegra

PF-03654764

Allegra-D

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Congestion scores

Other allergic rhinitis symptoms

Secondary Outcome Measures

Pharmacokinetics

Blood pressure/pulse rate

Adverse event reporting

Full Information

NCT ID

NCT01033396

First Posted

December 14, 2009

Last Updated

August 16, 2010

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01033396

Brief Title

The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

Official Title

A Randomized, Double Blind, Placebo Controlled, Four Way Crossover Study To Determine The Effects Of PF-03654764 +/- Allegra (Fexofenadine) On Symptoms Of Allergic Rhinitis In Subjects Exposed To Ragweed Pollen In An Environmental Exposure Unit.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

PF-03654764 should reduce the symptoms of allergic rhinitis. In this study patients will be exposed to pollen and their symptoms observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic rhinitis Environmental exposure unit

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-03654764 + Allegra

Arm Type

Experimental

Arm Title

PF-03654764

Arm Type

Experimental

Arm Title

Allegra-D

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

PF-03654764

Intervention Description

PF-03654764 single dose 5 mg

Intervention Type

Drug

Intervention Name(s)

Allegra

Intervention Description

Fexofenadine single dose 60 mg

Intervention Type

Drug

Intervention Name(s)

PF-03654764

Intervention Description

PF-03654764 single dose 5 mg

Intervention Type

Drug

Intervention Name(s)

Allegra-D

Intervention Description

Fexofenadine 60 mg combined with pseudoephedrine 120 mg single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo single dose

Primary Outcome Measure Information:

Title

Congestion scores

Time Frame

6 hours

Title

Other allergic rhinitis symptoms

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Pharmacokinetics

Time Frame

6 hours

Title

Blood pressure/pulse rate

Time Frame

6 hours

Title

Adverse event reporting

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects 18-60 years allergic to ragweed pollen. Subjects with appropriate symptom scores following exposure to ragweed in the environmental exposure unit. Exclusion Criteria: Subjects with significant diseases other than allergic rhinitis that may interfere with the safety or efficacy of PF-03654764. Subjects with significant symptoms of allergic rhinitis within the 2 weeks prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25024716

Citation

North ML, Walker TJ, Steacy LM, Hobsbawn BG, Allan RJ, Hackman F, Sun X, Day AG, Ellis AK. Add-on histamine receptor-3 antagonist for allergic rhinitis: a double blind randomized crossover trial using the environmental exposure unit. Allergy Asthma Clin Immunol. 2014 Jul 3;10(1):33. doi: 10.1186/1710-1492-10-33. eCollection 2014.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0711005&StudyName=The%20Effect%20Of%20PF-03654764%20+/-%20Allegra%20On%20Symptoms%20Of%20Allergic%20Rhinitis

Description

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The Effect Of PF-03654764 +/- Allegra On Symptoms Of Allergic Rhinitis

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