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

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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