Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fexofenadine

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Aventis Pharmaceuticals Inc.
Sanofi-Aventis Admnistrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Outcomes

Primary Outcome Measures

Change from baseline in Forced expiratory volume FEV1.

Secondary Outcome Measures

Change in Daily Asthma Symptoms Score from baseline.

Full Information

NCT ID

NCT00044811

First Posted

September 5, 2002

Last Updated

August 20, 2008

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00044811

Brief Title

Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

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 Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

March 2002 (undefined)

Primary Completion Date

October 2003 (Actual)

Study Completion Date

October 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Fexofenadine

Primary Outcome Measure Information:

Title

Change from baseline in Forced expiratory volume FEV1.

Secondary Outcome Measure Information:

Title

Change in Daily Asthma Symptoms Score from baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Aventis Pharmaceuticals Inc.

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-Aventis Admnistrative Office

City

Costa Rica

Country

Costa Rica

Facility Name