Long-Term Safety Performance of Fexofenadine in Asthma

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00045955
First received: September 17, 2002
Last updated: August 20, 2008
Last verified: August 2008
  Purpose

The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma


Condition Intervention Phase
Asthma
Drug: Fexofenadine, Comparator = Montelukast
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Randomized, Parallel Groups Study to Assess the Long-Term Safety Performance of Fexofenadine Compared to Montelukast in Subjects With Asthma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety evaluation

Secondary Outcome Measures:
  • Pulmonary function tests.

Estimated Enrollment: 1200
Study Start Date: February 2002
Study Completion Date: November 2003
Primary Completion Date: November 2003 (Final data collection date for primary outcome measure)
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. Oral leukotriene receptor antagonists (eg montelukast) are the latest class of inflammation-modulating asthma drugs and appear to cause fewer long-term side effects than systemic corticosteroids and reduce the need for shorter-acting bronchodilator reliever medicines. However variability in response between patients has been observed and clinical experience with these agents is still limited.

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 assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma.

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 40% and not less or equal to 87% of predicted values for subjects not currently taking ICS and greater than 40% and not less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no albuterol 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045955

Locations
United States, New Jersey
Aventis Pharmaceutical Inc.
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00045955     History of Changes
Other Study ID Numbers: M016455P/3003, M016455
Study First Received: September 17, 2002
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fexofenadine
Terfenadine
Montelukast
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 10, 2014