Asthma Clinical Trial
Official title:
A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
This randomized, double-blind, placebo-controlled trial assessed the efficacy of montelukast in the treatment of adults ≥50 years of age with persistent asthma and/or COPD. Primary outcomes included forced expiratory volume in one-second (FEV1) and daytime asthma symptoms scores. Nocturnal symptoms, asthma control, health-related quality of life, peak flow measurements, and health care utilization were also assessed as secondary outcomes. Participants were recruited from the Kaiser Permanente Northwest member population. One hundred forty-nine subjects were randomized to treatment with montelukast (10 mg per day) or placebo, and were followed for a six-week period. No differences in lung function measures, health-related quality of life, health care utilization, and asthma symptom scores were observed; however, the montelukast group had slightly improved asthma control scores compared to the placebo group.
Asthma and COPD are common chronic conditions in older adults. Adherence to therapy is an
important consideration since patients typically take two or more medications a day and
often have difficulties with inhaled breathing medications. Therefore, oral preparations,
such as leukotriene modifiers, have considerable appeal for older adults with asthma or
COPD. Phase 3 primary studies of the leukotriene modifier, montelukast sodium (Singulair),
for the management of asthma have included very few older adults.
The following randomized, double-blind, placebo-controlled study was designed as a pilot
study to evaluate the efficacy of montelukast, in addition to usual therapy, in the
treatment of older adults with asthma and/or COPD. Primary outcomes included
pre-bronchodilator forced expiratory volume in one-second (FEV1) and average daytime asthma
symptom scores.
Participants were recruited from Kaiser Permanente Northwest (KPNW), an HMO with 450,000
members in Portland, OR. All were adults ≥50 years of age with asthma and/or COPD who were
symptomatic despite using daily breathing medications. They were screened by phone to
collect information on asthma symptoms, medications, health care utilization, and co-morbid
illnesses. Eligible persons attended a baseline visit to further assess eligibility and
collect baseline data, including smoking status, co-morbidities, and participant
demographics. Spirometry was performed before and twenty minutes after administration of
four puffs of inhaled albuterol delivered by metered dose inhaler. All participants received
instructions about the use of a peak flow meter; maintenance of a daily asthma diary with
peak flow measurements, symptoms, and medications; and optimal use of an MDI by spacer.
Participants completed a two-week run-in period with placebo pills and used diaries to
record peak flow each morning, use of inhaled ß-agonist, nocturnal awakenings for asthma,
and occurrence of asthma attacks.
A total of 149 participants were randomized and received either montelukast(one 10 mg
tablet/day) (N=71) or placebo(one tablet/day) (N=78). Spirometry was repeated at the
randomization visit, and information on health status, asthma quality of life, and asthma
control was collected. Participants were followed for 6 weeks after randomization. A
telephone call was made at three-weeks to collect information about adverse experiences. At
the final visit, participants completed spirometry, and answered questions on health status,
asthma QOL and asthma control. Unscheduled health care visits for asthma during the six-week
study period were noted.
Results showed that improvement in asthma control was mixed. A small improvement in the
montelukast group was seen using one of the two control measures. There was no difference in
lung function, asthma symptom scores, health care utilization, or health-related quality of
life between the treatment and control groups.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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