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

NCT00911547 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 642

Last updated 2022-02-03

Study results available
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Summary

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

Conditions

Interventions

DRUG

montelukast sodium

10 mg tablet taken once daily at bedtime for 16 weeks

DRUG

beclomethasone

200 ug inhaled, taken twice daily for 16 weeks

DRUG

Placebo inhaler

placebo inhaler taken twice daily for 16 weeks

DRUG

placebo tablet

placebo tablet taken once daily at bedtime for 16 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-03-31
Primary Completion
1996-04-30
Completion
1996-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911547 on ClinicalTrials.gov