NCT00637884

CompletedPhase 4

A Single-Center, Randomized, Double-Blind, Placebo-Controlle...

Sanofi Source

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Other study identifiers

Sponsor study identifier

M016455A_4148

Study Type

interventional

Actual enrollment (reported)

70

Locations

0 countries

Sites

N/A

Timeline

Study Start

November 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

February 2004

Actual (reported)

Brief Summary

This is a single-center, prospective, randomized, double-blind, placebo-controlled, two-way crossover study. A live cat challenge model will be used for exposing subjects to Fel d1. Subjects who test positive for cat allergy symptoms during a priming cat exposure challenge will be eligible to enter the treatment phase of the study. Baseline efficacy measures will be obtained prior to the dispensing of study medication during both treatment periods. Cat challenges will be initiated 1.5 hours following treatment with study medication.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 70 participants
Study completion date: February 2004
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
February 2004
Actual (reported)
First Submitted
March 10, 2008
Actual (reported)
First Posted
March 18, 2008
Actual (reported)

Last Updated: January 11, 2011
Status Verified: January 2011
Last Update Submitted: January 10, 2011

Conditions

Cat Induced Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

Determine efficacy of fexofenadine HCl 180 mg versus placebo in preventing and controlling self-reported cat allergy symptoms in subjects who have a known allergy to cats and who are exposed to feline domesticus allergen 1

Secondary Outcomes (1)

Determine efficacy of fexofenadine HCl 180 mg compared to placebo in subjects with a known allergy to cats

Interventions

Fexofenadine HClDrug

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects, aged 12 years and older, inclusive
History of cat-induced allergic rhinitis for at least 2 years, requiring the use of allergy medication or resulting in avoidance of cats

Sponsors & Collaborators

Sanofi
Industrylead

MeSH Terms

Interventions

fexofenadine

Study Officials

Phyllis Diener
Sanofi
STUDY DIRECTOR

Enrollment

70 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 18, 2008

Study Start

November 2003

Date type not reported

This date has not been verified as actual or estimated.

Phase 1Completed

NCT00647985

Food Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Phase 1Completed

NCT00649376

Fasting Study of Fexofenadine Tablets 180 mg and Allegra® Tablets 180 mg

Phase 1Completed

NCT00835276

Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

Phase 1Completed

NCT00835640

Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions

Phase 1Completed

NCT00562120

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

Phase 2Completed

Skin test positive to cat allergen at screening, defined as a wheal greater than one-half the diameter of the histamine control and at least 3 mm larger than the diameter of the glycerin-saline solution control. A skin test performed in the previous 15 months may be used to qualify the subject if it was performed at the investigator's site and recorded in the subject's medical record

FEV1 greater than or equal to 80% of the predicted value on the screening assessment, and at the baseline assessment prior to the priming cat challenge(s). After the priming cat challenge, FEV1 must not have decreased \>12% from the pre-challenge testing % predicted value

Reversibility of \<12% in absolute FEV1 following 2 puffs of albuterol at screening

Minimal baseline allergic symptoms, defined as TSS less than or equal to 4 at the baseline assessments prior to the priming cat challenges

All females must have a negative urine pregnancy test

Willing and able to adhere to visit schedules and all study requirements

Mild to moderate allergic symptoms defined as TSS less than or equal to 8 at screening

You may not qualify if:

Asthma that requires treatment with medication other than inhaled, short-acting beta-agonists (not to be taken within 6 hours prior to the priming visit(s) or Visits 3 or 4) or asthma known to be exacerbated by exposure to Fel d1. (Subjects with exercise-induced asthma will be allowed.)
Requires medication for rhinitis that cannot be withheld
Has a cat in the home (Subjects who have cats who are exclusively outdoors will be allowed.)
Upper respiratory infection within 4 weeks of study entry
History of severe reactions to cat exposure by self-report (severe is defined as being unable to tolerate cat exposure for at least 30 minutes)
Acute or chronic sinusitis or other nasal diseases that resulted in nasal obstruction (e.g., nasal septum deviation, nasal polyps) within 4 weeks of study entry
Known hypersensitivity to fexofenadine HCl or to drugs with similar chemical structures
Clinically significant ECG values that, in the judgment of the investigator, would have clinical implications for the subject's participation in the study
Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), that, in the judgment of the investigator, might interfere with the study, require treatment or make implementation of the protocol or interpretation of the study results difficult
Pregnant or breast-feeding
Likely to require treatment during the study period with drugs not permitted by the study protocol
Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
Treatment with an investigational agent or device within 30 days prior to study entry
Recent history of alcohol or other drug abuse
Mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the study
+2 more criteria

Contact the study team to confirm eligibility.

Study Completion

February 2004

Actual (reported)

Last Updated

January 11, 2011

Record last verified: 2011-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00637884
Data provider: ClinicalTrials.gov
Source updated: 2011-01-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:37:06 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record