Clinical trial NCT02720081: Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)
timeFrame: Before the first dose of study investigational product (Baseline)
measure: Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6
timeFrame: Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment
Secondary outcomes:
measure: Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6
timeFrame: Up to 4 weeks
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 8 weeks
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to 6 weeks
measure: Change From Baseline in Alkaline Phosphatase (ALP) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Alanine Aminotransferase (ALT) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Aspartate Aminotransferase (AST) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Bilirubin at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Eosinophil (Percent [%]) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Neutrophil (%) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Platelet Count at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in White Blood Cell Count at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Hematocrit (%) at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Systolic Blood Pressure at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Systolic Blood Pressure at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Systolic Blood Pressure at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Diastolic Blood Pressure at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Diastolic Blood Pressure at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Diastolic Blood Pressure at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Heart Rate at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Heart Rate at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Heart Rate at Week 6
timeFrame: Baseline and Week 6
measure: Change From Baseline in Respiratory Rate at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Respiratory Rate at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in Respiratory Rate at Week 6
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: