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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Montelukast (ML); Drug: MK-1029

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624974

MK-1029-011 (Other Identifier)

1029-011

2012-000642-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of MK-1029 on lung function in the treatment of adults who have persistent asthma that is uncontrolled with the use of montelukast (ML). Participants will use randomized study drug (either MK-1029 or placebo) for two separate 4-week treatment periods. All participants will also use ML during the treatment periods. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

107 participants in 2 patient groups

MK-1029/Placebo

Experimental group

Description:

Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.

Treatment:

Drug: Placebo

Drug: Montelukast (ML)

Drug: MK-1029

Placebo/MK-1029

Experimental group

Description:

Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.

Treatment:

Drug: Placebo

Drug: Montelukast (ML)

Drug: MK-1029