A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
|ClinicalTrials.gov Identifier: NCT00162864|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : March 24, 2006
|Condition or disease||Intervention/treatment||Phase|
|Asthma COPD||Drug: montelukast sodium||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease|
|Study Start Date :||December 1999|
|Estimated Study Completion Date :||April 2002|
- Forced expiratory volume in one-second (FEV1)
- Daytime asthma symptoms scores
- Nocturnal symptoms
- Asthma control
- Asthma quality of life
- Health status
- Peak flow measurements
- Health care utilization
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162864
|United States, Oregon|
|Kaiser Permanente Center for Health Research|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||A. Sonia Buist, MD||Oregon Health and Science University|