Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00045955 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
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 |
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) |
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.
Ages Eligible for Study: | 12 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | M016455P/3003, M016455 |
Study First Received: | September 17, 2002 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00045955 |
Health Authority: | United States: Food and Drug Administration |
Montelukast Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Fexofenadine |
Hypersensitivity, Immediate Histamine phosphate Asthma Leukotriene Antagonists Histamine Respiratory Hypersensitivity |
Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Histamine Agents Anti-Allergic Agents Pharmacologic Actions Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating |