Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma - Tabular View

Tracking Information

First Received Date ^ICMJE

September 5, 2002

Last Updated Date

August 20, 2008

Start Date ^ICMJE

March 2002

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in Forced expiratory volume FEV1.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00044811 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Daily Asthma Symptoms Score from baseline.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Fexofenadine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1000

Completion Date

October 2003

Primary Completion Date

October 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Costa Rica, Guatemala, Hungary, Mexico, Poland, Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00044811

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

M016455P/3001, M016455

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP