Phase 2
Completed N=142
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
Source: ClinicalTrials.gov NCT02720081 ↗Enrolled (actual)
142
Serious AEs
0.7%
Results posted
Aug 2018
Primary outcomePrimary: Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) — 2.264; 2.234 Liter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) |
2.264; 2.234 | — |
| PRIMARY Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 |
0.152; 0.046 | 0.023 sig |
| SECONDARY Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 |
16.970; 21.746 | 0.352 |
| SECONDARY Percentage of Participants Who Experienced an Adverse Event (AE) |
25.7; 26.1 | — |
| SECONDARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
0.0; 4.3 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 |
61.16; 67.96; -0.83; 0.44 | — |
| SECONDARY Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 |
22.33; 19.35; -0.99; 0.34 | — |
| SECONDARY Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 |
23.53; 20.64; -0.09; 0.76 | — |
| SECONDARY Change From Baseline in Bilirubin at Week 6 |
0.62; 0.54; -0.00; -0.01 | — |
| SECONDARY Change From Baseline in Eosinophil (Percent [%]) at Week 6 |
4.40; 3.58; 0.11; 0.51 | — |
| SECONDARY Change From Baseline in Neutrophil (%) at Week 6 |
59.13; 57.86; -1.32; 0.12 | — |
| SECONDARY Change From Baseline in Platelet Count at Week 6 |
256.85; 258.44; -4.97; 2.65 | — |
| SECONDARY Change From Baseline in White Blood Cell Count at Week 6 |
6.76; 6.53; -0.08; 0.09 | — |
| SECONDARY Change From Baseline in Hematocrit (%) at Week 6 |
42.79; 42.64; -0.10; -0.33 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 2 |
118.89; 118.83; -1.61; -1.23 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 4 |
119.40; 118.82; -2.13; -1.99 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Week 6 |
119.40; 118.77; -0.34; -2.26 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 2 |
74.40; 74.45; -1.31; -0.97 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 4 |
74.60; 74.42; -1.56; -1.60 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Week 6 |
74.60; 74.29; -1.18; -0.95 | — |
| SECONDARY Change From Baseline in Heart Rate at Week 2 |
73.21; 74.20; -0.60; 0.45 | — |
| SECONDARY Change From Baseline in Heart Rate at Week 4 |
73.25; 73.96; -1.82; 1.40 | — |
| SECONDARY Change From Baseline in Heart Rate at Week 6 |
73.25; 73.80; -0.84; 1.06 | — |
| SECONDARY Change From Baseline in Respiratory Rate at Week 2 |
16.40; 17.23; -0.30; -1.17 | — |
| SECONDARY Change From Baseline in Respiratory Rate at Week 4 |
16.43; 17.18; -0.12; -0.97 | — |
| SECONDARY Change From Baseline in Respiratory Rate at Week 6 |
16.43; 17.20; -0.09; -1.17 | — |
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
Data sourced from ClinicalTrials.gov (NCT02720081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.