The purpose of this study is to assess the long-term safety performance of fexofenadine
compared to montelukast in subjects with 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. 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
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.
- Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
- FEV1 in the context of this study is greater than 40% and not less or equal to 87% of
predicted values for subjects not currently taking ICS and greater than 40% and not
less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no
albuterol 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).
- Otherwise healthy