Asthma Clinical Trial
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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