The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Study Overview

• Status: Completed
• Conditions: Chronic Asthma
• Intervention / Treatment: Drug: Comparator: montelukast; Drug: Comparator: placebo

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Exclusion Criteria:

• A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
• A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; montelukast Placebo	Drug: Comparator: montelukast; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; Other Names: SINGULAIR®, PROAIR® HFA; Drug: Comparator: placebo; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Experimental: 2; montelukast	Drug: Comparator: montelukast; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; Other Names: SINGULAIR®, PROAIR® HFA
Experimental: 3; montelukast	Drug: Comparator: montelukast; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; Other Names: SINGULAIR®, PROAIR® HFA
Experimental: 4; montelukast	Drug: Comparator: montelukast; 5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.; Other Names: SINGULAIR®, PROAIR® HFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FEV1 Over 4 Hours	FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.	0 (=baseline) to 4 hours after treatment with montelukast

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration	FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.	4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast	Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.	0 (baseline) and 8 hours after treatment with montelukast
Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast	Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.	0 (baseline) and 24 hours after treatment with montelukast

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimated): August 21, 2008

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Chronic asthma
• 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: 0476-388; MK0476-388; 2008_542

Plan for Individual participant data (IPD)

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

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php