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Completed

NCT Number: NCT02720081

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1029 150 mg

Drug

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

MK-1029 Matching-image Placebo

Drug

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

Montelukast 10 mg

Drug

10 mg tablet administered orally, QD, at bedtime

Other names: SINGULAIR®, Montelukast sodium

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

Primary outcomes

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

    Time frame: Before the first dose of study investigational product (Baseline)

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

  2. 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

    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.

Secondary outcomes

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

    Time frame: Up to 4 weeks

    A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake "all night"; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing.

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    Time frame: Up to 8 weeks

    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

  3. Percentage of Participants Who Discontinued Study Drug Due to an AE

    Time frame: Up to 6 weeks

    An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

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

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

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

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  6. Change From Baseline in Aspartate Aminotransferase (AST) at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  7. Change From Baseline in Bilirubin at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  8. Change From Baseline in Eosinophil (Percent [%]) at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  9. Change From Baseline in Neutrophil (%) at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  10. Change From Baseline in Platelet Count at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  11. Change From Baseline in White Blood Cell Count at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  12. Change From Baseline in Hematocrit (%) at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.

  13. Change From Baseline in Systolic Blood Pressure at Week 2

    Time frame: Baseline and Week 2

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  14. Change From Baseline in Systolic Blood Pressure at Week 4

    Time frame: Baseline and Week 4

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  15. Change From Baseline in Systolic Blood Pressure at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  16. Change From Baseline in Diastolic Blood Pressure at Week 2

    Time frame: Baseline and Week 2

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  17. Change From Baseline in Diastolic Blood Pressure at Week 4

    Time frame: Baseline and Week 4

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  18. Change From Baseline in Diastolic Blood Pressure at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  19. Change From Baseline in Heart Rate at Week 2

    Time frame: Baseline and Week 2

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  20. Change From Baseline in Heart Rate at Week 4

    Time frame: Baseline and Week 4

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  21. Change From Baseline in Heart Rate at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  22. Change From Baseline in Respiratory Rate at Week 2

    Time frame: Baseline and Week 2

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  23. Change From Baseline in Respiratory Rate at Week 4

    Time frame: Baseline and Week 4

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

  24. Change From Baseline in Respiratory Rate at Week 6

    Time frame: Baseline and Week 6

    Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 25, 2016
Registry last updated
Sep 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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