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Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044824
Recruitment Status : Completed
First Posted : September 17, 2002
Last Update Posted : August 21, 2008
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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

Condition or disease Intervention/treatment Phase
Asthma Drug: Fexofenadine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Change from baseline in Forced Expiratory Volume FEV1

Secondary Outcome Measures :
  1. Change in Daily Asthma Symptoms Score from baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044824

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United States, New Jersey
Aventis Pharmaceuticals Inc.
Bridgewater, New Jersey, United States, 08807
Costa Rica
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
Russian Federation
Sanofi-Aventis Aministrative Office
Moscow, Russian Federation
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Additional Information:
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00044824    
Other Study ID Numbers: M016455P/3002
First Posted: September 17, 2002    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs