Asthma Clinical Trial
Official title:
A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Verified date | September 2005 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | April 2002 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Kaiser Permanente Center for Health Research | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente | Merck Sharp & Dohme Corp. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced expiratory volume in one-second (FEV1) | |||
Primary | Daytime asthma symptoms scores | |||
Secondary | Nocturnal symptoms | |||
Secondary | Asthma control | |||
Secondary | Asthma quality of life | |||
Secondary | Health status | |||
Secondary | Peak flow measurements | |||
Secondary | Health care utilization |
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