A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

Completed · Phase 3

Conditions studied: Asthma, COPD

In brief

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.

Key facts

Study ID

NCT00162864

Run by

Kaiser Permanente

People needed

200

Starts

1999-12-01

Expected to finish

2002-04-01

Last updated by the study team

2006-03-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age ≥50 years
• persistent asthma symptoms
• using short-acting ß-adrenergic agonists medication
• willingness and ability to keep a daily symptom diary
• willingness to perform peak flow monitoring
• health plan membership for at least 6 months
• use of any combination of ß-agonists and inhaled corticosteroids, theophylline, cromolyn, nedocromil, or ipratropium bromide

You may not qualify if…

• unable to provide informed consent
• not available for duration of study
• dementia
• chronic lung disease other than asthma or COPD
• clinically significant, active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems
• a major surgical procedure within the four weeks prior to the baseline visit
• previous adverse reaction to montelukast
• unresolved symptoms of an upper respiratory tract infection within three weeks prior to baseline
• initiation of immunotherapy within six months before enrollment or the dose of immunotherapy was expected to change over the course of the study
• inability to adequately perform spirometry
• use of leukotriene modifiers within the past two weeks
• use of oral corticosteroids within the past 30 days
• more than one emergency department visit for asthma within the past 30 days
• more than two emergency department visits for asthma in the past six months
• hospitalization for asthma or COPD within the past six months

Where it is running

• Kaiser Permanente Center for Health Research — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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