Asthma in the Elderly: The Effect of Montelukast

This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years
old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the
treatment of asthma in subjects who are 12 month old and older. This study is being done
because there has been no placebo controlled study of montelukast focused on this group of
patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more
likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to
younger asthmatics. The pathophysiology of asthma in the elderly is typically different than
in younger patients. This is a double-blind, placebo-controlled, crossover study.
Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at
least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco
products in their lifetime. After a run-in period of one week, the study subjects will take
montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa.
Primary objectives of this study are to evaluate the effect of montelukast on asthma
symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs
of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether
montelukast affects peripheral blood eosinophils counts and serum IgE levels.