A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study Designed to Evaluate the Efficacy of Fexofenadine HCl 180 mg for Preventing and Controlling Cat Allergy Symptoms

January 10, 2011 updated by: Sanofi
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • Unlikely to comply with the protocol (e.g., has an uncooperative attitude, is unlikely to complete the study)
  • Subjects who are research employees or relatives of study site staff involved in this study or those who have or will read the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Determine efficacy of fexofenadine HCl 180 mg compared to placebo in subjects with a known allergy to cats

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M016455A_4148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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