Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
Efficacy and Safety of Fexofenadine in 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.
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 60% and not less or equal to 87% of
 predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist 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