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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00162864
First received: September 8, 2005
Last updated: March 23, 2006
Last verified: September 2005
  Purpose

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 Intervention Phase
Asthma
COPD
Drug: montelukast sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

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

Secondary Outcome Measures:
  • Nocturnal symptoms
  • Asthma control
  • Asthma quality of life
  • Health status
  • Peak flow measurements
  • Health care utilization

Estimated Enrollment: 200
Study Start Date: December 1999
Estimated Study Completion Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162864

Locations
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: A. Sonia Buist, MD Oregon Health and Science University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162864     History of Changes
Other Study ID Numbers: MONTE, SING-US-75-99
Study First Received: September 8, 2005
Last Updated: March 23, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
asthma
COPD
montelukast sodium
leukotriene modifier
older adults

Additional relevant MeSH terms:
Asthma
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014