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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00637884
First received: March 10, 2008
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Cat Induced Allergic Rhinitis
Drug: Fexofenadine HCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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:
  • Determine efficacy of fexofenadine HCl 180 mg compared to placebo in subjects with a known allergy to cats

Enrollment: 70
Study Start Date: November 2003
Study Completion Date: February 2004
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637884

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Phyllis Diener Sanofi
  More Information

No publications provided

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00637884     History of Changes
Other Study ID Numbers: M016455A_4148
Study First Received: March 10, 2008
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fexofenadine
Terfenadine
Anti-Allergic Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014