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Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fexofenadine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
ICD CSD, Study Director, Affiliation: Sanofi

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

Clinical Details

Official title: A Multicenter, Double-Blind, Randomized, Parallel Groups Placebo-Controlled Study to Assess the Efficacy and Safety of Fexofenadine 120mg BID in Subjects With Mild to Moderate Persistent Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change from baseline in Forced Expiratory Volume FEV1

Secondary outcome: Change in Daily Asthma Symptoms Score from baseline.

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.

Eligibility

Minimum age: 12 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- Males and non-pregnant, non-breastfeeding females 12 through 80 years of age

- FEV1 in the context of this study is greater than 60% and not less or equal to 87% of

predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry)

- Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15

to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.

- Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of

at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use). Exclusion criteria:

- Otherwise healthy

Locations and Contacts

Sanofi-Aventis Admnistrative Office, Costa Rica, Costa Rica

Sanofi-Aventis Administrative Office, Guatemala City, Guatemala

sanofi-aventis Hungaria, Budapest, Hungary

Sanofi-Aventis Administrative Office, Mexico, Mexico

sanofi-aventis Poland, Warszawa, Poland

Sanofi-Aventis Aministrative Office, Moscow, Russian Federation

Aventis Pharmaceuticals Inc., Bridgewater, New Jersey 08807, United States

Additional Information

Starting date: February 2002
Last updated: August 20, 2008

Page last updated: August 23, 2015

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