Status:
COMPLETED
A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
COPD
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 f...
Detailed Description
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 difficultie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 1999
Trial Type :
INTERVENTIONAL
End Date :
April 1 2002
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00162864
Start Date
December 1 1999
End Date
April 1 2002
Last Update
March 24 2006
Active Locations (1)
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1
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227