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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00162864
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : March 24, 2006
Merck Sharp & Dohme Corp.
Information provided by:
Kaiser Permanente

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 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.

Condition or disease Intervention/treatment Phase
Asthma COPD Drug: montelukast sodium Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease
Study Start Date : December 1999
Study Completion Date : April 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Primary Outcome Measures :
  1. Forced expiratory volume in one-second (FEV1)
  2. Daytime asthma symptoms scores

Secondary Outcome Measures :
  1. Nocturnal symptoms
  2. Asthma control
  3. Asthma quality of life
  4. Health status
  5. Peak flow measurements
  6. Health care utilization

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00162864

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United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Merck Sharp & Dohme Corp.
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Principal Investigator: A. Sonia Buist, MD Oregon Health and Science University
Layout table for additonal information Identifier: NCT00162864    
Other Study ID Numbers: MONTE
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: March 24, 2006
Last Verified: September 2005
Keywords provided by Kaiser Permanente:
montelukast sodium
leukotriene modifier
older adults
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action