Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit (Study I)

Sanofi1 site in 1 country1,010 target enrollmentFebruary 2003

ConditionsSeasonal Allergic Rhinitis

DrugsFexofenadine HCl

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Seasonal Allergic Rhinitis
Sponsor: Sanofi
Enrollment: 1010
Locations: 1
Primary Endpoint: To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo. Secondary objectives are to compare the safety and efficacy of fexofenadine hydrochloride 180 mg, montelukast sodium 10 mg, and placebo

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

April 2003

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Male and female subjects, 15 years of age or older
•History of seasonal allergic rhinitis (SAR) during the fall pollen season, for at least the previous 2 years
•History of having a positive response to antihistamines for symptoms of SAR
•Must be skin test positive to ragweed within the last 15 months with at least a moderate reaction as defined by a wheal 7 mm greater than the diluent wheal after intradermal skin test or a wheal 5 mm greater than the diluent wheal after skin prick test. A skin test performed in the previous 15 months may be used to qualify the patient if it was performed at the investigator's site and recorded in the subject's medical record
•All females must have negative urine pregnancy test at screening visit
•Willing and able to adhere to visit schedules and all study requirements

Exclusion Criteria

•Clinically significant medical condition (such as cardiovascular, hepatic, neurologic, hematological, renal, gastrointestinal, endocrine, or other major systemic disease), which, 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
•Asthma that requires treatment with medication other than an inhaled, short-acting beta agonist or asthma that will be exacerbated by exposure to ragweed pollen
•Pregnancy or breast-feeding
•History of hypersensitivity to the study medications or to drugs with similar chemical structures
•Nasal structural abnormalities, including large nasal polyps or marked septal deviation, that significantly interfere with nasal air flow
•Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
•Upper or lower respiratory infection within 14 days of the first priming visit
•Diagnosis of sinusitis within 30 days of the first priming visit
•Immunotherapy, except those on a constant dose of immunotherapy that will be maintained throughout the study
•Treatment with any investigational drug in the last 30 days before study entry

Outcomes

Primary Outcomes

To determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo in the treatment of subjects with moderately severe seasonal allergic rhinitis (SAR) in a controlled setting.