Asthma in the Elderly: The Effect of Montelukast

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635334
• Other study ID #: SSRF2015-01
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2015
• Last updated: October 4, 2016
• Start date: November 2015
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast 10 mg orally

Other:
• Placebo

Locations

Country	Name	City	State
United States	Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.	Bryn Mawr	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of montelukast on asthma symptoms assessed by daily symptom scores.		8 weeks	No
Primary	Effect of montelukast on the Asthma Control Test.		8 weeks	No
Primary	Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.		8 weeks	No
Primary	Effect of montelukast on lung capacity assessed by spirometry (FEV1).		8 weeks	No
Secondary	Effect of montelukast on peripheral blood eosinophils counts.		8 weeks	No
Secondary	Effect of montelukast on total serum IgE.		8 weeks	No