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

NCT02720081 | Completed Phase 2 Results

• 4 other identifiers: 1029-0152015-005054-36MK-1029-015163313
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief 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

Asthma

Outcome Measures

Primary Outcomes (2)

• Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)

  FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.

  Before the first dose of study investigational product (Baseline)

• Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6

  FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6.

  Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment

Secondary Outcomes (24)

• Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6

  Up to 4 weeks

• Percentage of Participants Who Experienced an Adverse Event (AE)

  Up to 8 weeks

• Percentage of Participants Who Discontinued Study Drug Due to an AE

  Up to 6 weeks

• Change From Baseline in Alkaline Phosphatase (ALP) at Week 6

  Baseline and Week 6

• Change From Baseline in Alanine Aminotransferase (ALT) at Week 6

  Baseline and Week 6

Study Arms (2)

MK-1029 150 mg + Montelukast 10 mg

EXPERIMENTAL

Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

Drug: MK-1029 150 mg; Drug: Montelukast 10 mg; Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

MK-1029 Placebo + Montelukast 10 mg

PLACEBO COMPARATOR

Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed.

Drug: MK-1029 Matching-image Placebo; Drug: Montelukast 10 mg; Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Interventions

MK-1029 150 mg DRUG

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

MK-1029 150 mg + Montelukast 10 mg

MK-1029 Matching-image Placebo DRUG

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

MK-1029 Placebo + Montelukast 10 mg

Montelukast 10 mg DRUG

10 mg tablet administered orally, QD, at bedtime

Also known as: SINGULAIR®, Montelukast sodium

MK-1029 150 mg + Montelukast 10 mg; MK-1029 Placebo + Montelukast 10 mg

Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation DRUG

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

MK-1029 150 mg + Montelukast 10 mg; MK-1029 Placebo + Montelukast 10 mg

Eligibility Criteria

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

You may qualify if:

• Symptoms of persistent asthma for at least one year
• History of asthma treatments including "as-needed" inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LABA) and/or oral asthma controller(s)
• Must be able to discontinue or taper asthma controlling medications while receiving Montelukast
• No history of smoking or no smoking for at least 1 year, with a smoking history of no more than 10 pack-years
• Body Mass Index (BMI) of 15 kg/m\^2 to 40 kg/m\^2.
• Females must not be pregnant (negative serum human chorionic gonadotropin test) or breastfeeding and must not plan to become pregnant for the duration of the study, including the post-treatment follow-up period
• Women and male participants of reproductive potential must agree to use adequate contraception for the duration of the study

You may not qualify if:

• Evidence of another active pulmonary disorder such as bronchiectasis or chronic obstructive pulmonary disease (COPD)
• Unable to perform acceptable, repeatable spirometry
• History of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months of screening visit
• Major surgical procedure(s) within 4 weeks of screening visit
• Blood donation within 2 weeks of screening visit
• Treatment in an emergency room for asthma (within 4 weeks) or hospitalization for asthma or respiratory condition within 2 months of screening visit
• Evidence of active sinus disease within 2 weeks of screening visit
• Upper respiratory infection (viral or bacterial) within 1 month of screening visit
• History of a psychiatric disorder within 3 months of screening visit
• History of human immunodeficiency virus (HIV)
• Unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems
• History of cancer (except for successfully treated basal and squamous cell carcinomas of the skin) within 5 years of screening visit
• Uncontrolled hypertension
• Participation in a clinical trial involving an investigational drug within 4 weeks of screening visit
• Hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors or any of their ingredients, including lactose and galactose

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

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 Director

  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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 25, 2016
• Study Start: May 11, 2016
• Primary Completion: August 16, 2017
• Study Completion: September 6, 2017
• Last Updated: September 27, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share