Asthma in the Elderly: The Effect of Montelukast

NCT02635334 | Completed Phase 4

• 1 other identifier: SSRF2015-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Effect of montelukast on peripheral blood eosinophils counts.

  8 weeks

• Effect of montelukast on total serum IgE.

  8 weeks

Study Arms (2)

Montelukast 10 mg daily for 8 weeks

EXPERIMENTAL

Study subjects will take montelukast 10 mg orally daily for 8 weeks

Drug: Montelukast 10 mg orally; Other: Placebo

Placebo daily for 8 weeks

PLACEBO COMPARATOR

Study subjects will take placebo orally daily for 8 weeks

Drug: Montelukast 10 mg orally; Other: Placebo

Interventions

Montelukast 10 mg orally DRUG

Also known as: Singulair

Montelukast 10 mg daily for 8 weeks; Placebo daily for 8 weeks

Placebo OTHER

Montelukast 10 mg daily for 8 weeks; Placebo daily for 8 weeks

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.: lead

Study Sites (1)

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

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michele Columbo, M.D.

  Rohr and Columbo Asthma, Allergy, and Immunology Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 18, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)