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.
Phase:
Phase 4
Details
Lead Sponsor:
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.