Asthma in the Elderly: The Effect of Montelukast

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Placebo; Drug: Montelukast 10 mg orally

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Montelukast 10 mg daily for 8 weeks; Study subjects will take montelukast 10 mg orally daily for 8 weeks	Other: Placebo; Drug: Montelukast 10 mg orally; Other Names: Singulair
PLACEBO_COMPARATOR: Placebo daily for 8 weeks; Study subjects will take placebo orally daily for 8 weeks	Other: Placebo; Drug: Montelukast 10 mg orally; Other Names: Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effect of montelukast on asthma symptoms assessed by daily symptom scores.	8 weeks
Effect of montelukast on the Asthma Control Test.	8 weeks
Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.	8 weeks
Effect of montelukast on lung capacity assessed by spirometry (FEV1).	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of montelukast on peripheral blood eosinophils counts.	8 weeks
Effect of montelukast on total serum IgE.	8 weeks

Collaborators and Investigators

• Sponsor: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
• Investigators: Principal Investigator: Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy, and Immunology Specialists

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 15, 2015
• First Posted (ESTIMATE): December 18, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: SSRF2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO