Long-Term Safety Performance of Fexofenadine in Asthma
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|ClinicalTrials.gov Identifier: NCT00045955|
Recruitment Status : Completed
First Posted : September 19, 2002
Last Update Posted : August 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Fexofenadine, Comparator = Montelukast||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 2002|
|Primary Completion Date :||November 2003|
|Study Completion Date :||November 2003|
- Safety evaluation
- Pulmonary function tests.
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 ClinicalTrials.gov identifier (NCT number): NCT00045955
|United States, New Jersey|
|Aventis Pharmaceutical Inc.|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||ICD CSD||Sanofi|