Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
not pregnant or breastfeeding and does not plan to become pregnant for the duration of the study;
symptoms of persistent asthma for at least one year;
current use of asthma treatments: 1) "as-needed" inhaled SABAs (albuterol/salbutamol) and no asthma controller for at least 4 weeks prior to Screening Visit OR 2) stable dose of ICS, combination ICS/LABA and/or oral asthma controller(s) for at least 4 weeks prior to Screening Visit and able to tolerate discontinuing all controllers while receiving ML;
no history of smoking OR no smoking for at least 1 year, with a smoking history of no more than 10 pack-years;
able to maintain a constant day/night, awake/sleep cycle;
agrees to not change habitual consumption of beverages or foods containing caffeine throughout the study;
Body Mass Index (BMI) of 15 kg/m\^2 to 40 kg/m\^2.
You may not be if
history of myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia within 3 months prior to Screening Visit;
hospitalized or hospitalization within 4 weeks prior to Screening Visit;
intention of moving or anticipation of missing any study visits;
any major surgical procedure(s) within 4 weeks prior to Screening Visit;
participation in a clinical trial involving an investigational drug within 4 weeks prior to Screening Visit;
current regular use or a recent past abuse (within past 5 years) of alcohol (\>14 drinks/week) or illicit drugs;
donation of a unit of blood within 2 weeks prior to Screening Visit or intention of donating a unit of blood during the study;
evidence of another active pulmonary disorder such as bronchiectasis or COPD;
treatment in an emergency room for asthma within 4 weeks prior to Screening Visit or hospitalization for asthma within 2 months prior to Screening Visit;
respiratory tract infection which required treatment with antibiotics within 2 months prior to Screening Visit;
evidence of active sinus disease within 1 week prior to Screening Visit;
history of a psychiatric disorder, other than stable depression, within 3 months prior to Screening Visit;
history of human immunodeficiency virus (HIV);
hypersensitivity or intolerance to inhaled beta-agonists and/or leukotriene inhibitors or any of their ingredients, including lactose and galactose;
unstable disease of the ophthalmologic, neurological, hepatic, renal, connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic systems;
cancer (except for successfully treated basal and squamous cell carcinomas of the skin) or history of cancer within 5 years prior to Screening Visit;
uncontrolled hypertension.
Clareo Health | Study to Evaluate the Effectiveness and Safety of MK-1029 in the Treatment of Persistent Asthma That is Not Controlled With Montelukast (ML) in Adults (MK-1029-011)
