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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02720081
• Date of registration: 22/03/2016
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
• Scientific title: A Phase-II, Randomized, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Safety of MK-1029 in Adult Subjects With Persistent Asthma That is Uncontrolled While Receiving Montelukast.
• Date of first enrolment: May 11, 2016
• Target sample size: 142
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02720081
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Guatemala, Japan, Malaysia, Poland, South Africa

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Known sensitivity to or has not had previous exposure to aspirin or non-steroidal
anti-inflammatory drugs



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation

Drug: MK-1029 Matching-image Placebo

Drug: MK-1029 150 mg

Drug: Montelukast 10 mg

Primary Outcome(s)

Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 [Time Frame: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment]

Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) [Time Frame: Before the first dose of study investigational product (Baseline)]

Secondary Outcome(s)

Change From Baseline in Hematocrit (%) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Respiratory Rate at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Systolic Blood Pressure at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Heart Rate at Week 2 [Time Frame: Baseline and Week 2]

Change From Baseline in Neutrophil (%) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Platelet Count at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Diastolic Blood Pressure at Week 2 [Time Frame: Baseline and Week 2]

Change From Baseline in Systolic Blood Pressure at Week 4 [Time Frame: Baseline and Week 4]

Change From Baseline in White Blood Cell Count at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Diastolic Blood Pressure at Week 4 [Time Frame: Baseline and Week 4]

Change From Baseline in Heart Rate at Week 4 [Time Frame: Baseline and Week 4]

Percentage of Participants Who Experienced an Adverse Event (AE) [Time Frame: Up to 8 weeks]

Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 [Time Frame: Baseline and Week 6]

Percentage of Participants Who Discontinued Study Drug Due to an AE [Time Frame: Up to 6 weeks]

Change From Baseline in Bilirubin at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Diastolic Blood Pressure at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Systolic Blood Pressure at Week 2 [Time Frame: Baseline and Week 2]

Change From Baseline in Eosinophil (Percent [%]) at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Heart Rate at Week 6 [Time Frame: Baseline and Week 6]

Change From Baseline in Respiratory Rate at Week 2 [Time Frame: Baseline and Week 2]

Change From Baseline in Respiratory Rate at Week 4 [Time Frame: Baseline and Week 4]

Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 [Time Frame: Up to 4 weeks]

Secondary ID(s)

163313

1029-015

2015-005054-36

MK-1029-015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02720081