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Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)

NCT02720081 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2018-09-27

Study results available
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Summary

The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone. Participants will have a specific genetic marker for clinical efficacy of MK-1029. The primary hypothesis is that when added to montelukast, treatment with MK-1029 is superior to placebo, as demonstrated by an increase in forced expiratory volume in one second (FEV1), measured as the average change from baseline at the end of Week 4 and Week 6 of treatment.

Conditions

Interventions

DRUG

MK-1029 150 mg

150 mg tablet administered orally, once a day (QD), at bedtime

DRUG

MK-1029 Matching-image Placebo

Matching-image placebo tablet administered orally, QD, at bedtime

DRUG

Montelukast 10 mg

10 mg tablet administered orally, QD, at bedtime

DRUG

Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2017-08-16
Completion
2017-09-06

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Entities

Diseases
Companies

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 NCT02720081 on ClinicalTrials.gov