Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00044824
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

Detailed Description

The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment.

Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory properties at concentrations achieved at therapeutic dosages suggesting an additional benefit of these drugs in the management of allergic diseases and asthma. The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma.

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-09-05
• Study First Submitted QC: 2002-09-16
• Study First Posted: 2002-09-17
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in Forced Expiratory Volume FEV1

Secondary Outcome Measures

Name	Time	Method
Change in Daily Asthma Symptoms Score from baseline.

Trial Locations

Locations (6)

Sanofi-Aventis Administrative Office; 🇲🇽 Mexico, Mexico

Sanofi-Aventis Admnistrative Office; 🇨🇷 Costa Rica, Costa Rica

sanofi-aventis Hungaria; 🇭🇺 Budapest, Hungary

Sanofi-Aventis Aministrative Office; 🇷🇺 Moscow, Russian Federation

Aventis Pharmaceuticals Inc.; 🇺🇸 Bridgewater, New Jersey, United States

sanofi-aventis Poland; 🇵🇱 Warszawa, Poland