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

NCT00911547 | Completed Phase 3 Results

• 2 other identifiers: 0476-0292009_596
• Study Type: interventional
• Target: 642
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Keywords

chronic asthma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use

  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

  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

  Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Study Arms (4)

1

EXPERIMENTAL

Montelukast + Beclomethasone

Drug: montelukast sodium; Drug: beclomethasone

2

EXPERIMENTAL

Montelukast + Placebo inhaler

Drug: montelukast sodium; Drug: Placebo inhaler

3

EXPERIMENTAL

Placebo tablet + Beclomethasone

Drug: beclomethasone; Drug: placebo tablet

4

PLACEBO COMPARATOR

Placebo tablet + Placebo inhaler

Drug: Placebo inhaler; Drug: placebo tablet

Interventions

montelukast sodium DRUG

10 mg tablet taken once daily at bedtime for 16 weeks

Also known as: MK0476

1; 2

beclomethasone DRUG

200 ug inhaled, taken twice daily for 16 weeks

1; 3

Placebo inhaler DRUG

placebo inhaler taken twice daily for 16 weeks

2; 4

placebo tablet DRUG

placebo tablet taken once daily at bedtime for 16 weeks

3; 4

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 10588598 RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Limitations and Caveats

Efficacy over 16 weeks of treatment for Beclo and MK+Beclo groups, and last 10 weeks for Placebo and MK groups to minimize confounding effect of beclo in 1st 4 weeks of treatment and to allow beclo washout.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 2, 2009
• Study Start: March 1, 1995
• Primary Completion: April 1, 1996
• Study Completion: May 1, 1996
• Last Updated: February 3, 2022
• Results First Posted: June 9, 2010

Record last verified: 2022-02