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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Asthma

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02720081
MK-1029-015 (Other Identifier)
1029-015
2015-005054-36 (EudraCT Number)
163313 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

142 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

142 participants in 2 patient groups, including a placebo group

MK-1029 150 mg + Montelukast 10 mg
Experimental group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
Drug: Montelukast 10 mg
Drug: Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
Drug: MK-1029 Matching-image Placebo

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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