The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: montelukast sodium; Drug: beclomethasone; Drug: Placebo inhaler; Drug: placebo tablet

• Study Type: Interventional
• Enrollment (Actual): 642
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
• Patient was a nonsmoker
• Patient was in good general health (except for asthma)

Exclusion Criteria:

• Patient was hospitalized
• Patient was female who was less than 8 weeks postpartum or breast feeding
• Patient planned to move or vacation away during the study
• Patient had major surgery within 4 weeks the past 4 weeks
• Patient has donated blood or participated in a clinical trial within the past 4 weeks
• Patient was a regular user or recent abuser of alcohol or illicit drugs
• Patient was 40% over or under normal weight for height

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Montelukast + Beclomethasone	Drug: montelukast sodium; 10 mg tablet taken once daily at bedtime for 16 weeks; Other Names: MK0476; Drug: beclomethasone; 200 ug inhaled, taken twice daily for 16 weeks
Experimental: 2; Montelukast + Placebo inhaler	Drug: montelukast sodium; 10 mg tablet taken once daily at bedtime for 16 weeks; Other Names: MK0476; Drug: Placebo inhaler; placebo inhaler taken twice daily for 16 weeks
Experimental: 3; Placebo tablet + Beclomethasone	Drug: beclomethasone; 200 ug inhaled, taken twice daily for 16 weeks; Drug: placebo tablet; placebo tablet taken once daily at bedtime for 16 weeks
Placebo Comparator: 4; Placebo tablet + Placebo inhaler	Drug: Placebo inhaler; placebo inhaler taken twice daily for 16 weeks; Drug: placebo tablet; placebo tablet taken once daily at bedtime for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma	Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups	Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma	The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use	Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma	Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only	Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042.

Study record dates

Study Major Dates

• Study Start: March 1, 1995
• Primary Completion (Actual): April 1, 1996
• Study Completion (Actual): May 1, 1996

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• 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; Anti-Inflammatory Agents; Glucocorticoids; Hormones; 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; Beclomethasone
• Other Study ID Numbers: 0476-029; 2009_596