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Completed

NCT Number: NCT02635334

Asthma in the Elderly: The Effect of Montelukast

This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Bryn Mawr, Pennsylvania, 19010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asthma diagnosed for at least one year;
  • Able to swallow small capsules.

Exclusion criteria

  • Tobacco smoking for more than 10/pack years;
  • Previous adverse reaction to montelukast or other leukotriene inhibitor;
  • History of hypereosinophilic disorder other than atopic disease;
  • Treatment with montelukast within 4 weeks from randomization;
  • Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.

Treatment and study plan

Montelukast 10 mg orally

Drug

Other names: Singulair

Placebo

Other

Primary outcomes

  1. Effect of montelukast on asthma symptoms assessed by daily symptom scores.

    Time frame: 8 weeks

  2. Effect of montelukast on the Asthma Control Test.

    Time frame: 8 weeks

  3. Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.

    Time frame: 8 weeks

  4. Effect of montelukast on lung capacity assessed by spirometry (FEV1).

    Time frame: 8 weeks

Secondary outcomes

  1. Effect of montelukast on peripheral blood eosinophils counts.

    Time frame: 8 weeks

  2. Effect of montelukast on total serum IgE.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Other

Registry information

Official study title

Asthma in the Elderly: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Effect of Montelukast

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 18, 2015
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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