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

NCT00562120 | Completed Phase 2 Results

• 1 other identifier: A8801003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Minimum Cross-Sectional Area (Amin) Proportion Measured Using Acoustic Rhinometry

  Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Minimum Cross-Sectional Area (Amin) at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hours (hrs) 10 minutes (min), 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Amin 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Amin proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

• Nasal Volume Proportion Measured Using Acoustic Rhinometry

  Acoustic rhinometry: a technique intended for assessment of the geometry of nasal cavity and nasopharynx and for evaluating nasal obstruction. At each time point, there were 2 acoustic rhinometry measurements taken, one for each nostril. Mean of the left and right nostril measurements was taken as measurement at each time point. Nasal volume at Baseline was defined as mean of 3, 'post-diluent, pre-allergen challenge' measures for each intervention period at 2 hrs 10 min, 2 hrs 25 min and 2 hrs 40 min post PF-03654746/placebo dose. Nasal volume 'post-allergen challenge' measures recorded at 2 hrs 55 min, 3 hrs 10 min and 3 hrs 25 min post PF-03654746/placebo dose for each intervention period was averaged to derive single 'post-allergen challenge' value. Nasal volume proportion was defined as ratio of 'post-allergen challenge' value and 'Baseline/pre-allergen challenge value'. Diluent used was saline and allergen was short ragweed extract.

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Secondary Outcomes (4)

• Minimum Cross-Sectional Area (Amin) Maximum Fall Measured Using Acoustic Rhinometry

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

• Nasal Volume Maximum Fall Measured Using Acoustic Rhinometry

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

• Nasal Symptom Scores: Nasal Congestion, Nasal Itching, Rhinorrhea

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Pre-allergen challenge); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose (Post-allergen challenge); 3 hrs 40 min post dose (Post-oxymetazoline) on Day 1 of each intervention period

• Nasal Symptom Scores: Sneezing

  2 hrs 10 min, 2 hrs 25 min, 2 hrs 40 min post dose (Baseline); 2 hrs 55 min, 3 hrs 10 min, 3 hrs 25 min post dose on Day 1 of each intervention period

Other Outcomes (1)

• Serum PF-03654746 Concentration

  1 hr 30 min post dose on Day 1 of each intervention period

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Allegra

ACTIVE COMPARATOR

Drug: Allegra

Allegra-D

ACTIVE COMPARATOR

Drug: Allegra-D

PF-03654746

EXPERIMENTAL

Drug: PF-03654746

Interventions

Placebo 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.

Placebo

Allegra DRUG

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

Allegra

Allegra-D DRUG

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

Allegra-D

PF-03654746 DRUG

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

PF-03654746

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of asthma or FEV1 \< 80% predicted.
• Significant concomitant disease or medications.
• Symptoms of allergic rhinitis within 2 weeks prior to screening.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

fexofenadine; N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: April 16, 2014

Record last verified: 2014-03

Locations

US (1)