A Phase 3 interventional study of Fexofenadine in Asthma, sponsored by Sanofi. Completed at 7 sites in 7 countries. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-08-21.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Change from baseline in Forced expiratory volume FEV1.
Change in Daily Asthma Symptoms Score from baseline.
This study is completed, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Sanofi