A Dose-Ranging Study of MK-1029 in Adults With Persistent Asthma (MK-1029-012 AM2)



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:5/5/2014
Start Date:August 2012
End Date:July 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma

The purpose of this adaptive-design study is to evaluate the dose-related effectiveness and
safety of MK-1029, alone or in combination with montelukast, compared to placebo and to
montelukast alone, in the treatment of persistent asthma in adults.


Inclusion Criteria:

- not pregnant or breastfeeding, and not planning to become pregnant during the study

- history of symptoms of persistent asthma for at least one year

- current use of acceptable asthma treatments and willingness to taper or discontinue
these treatments; acceptable asthma treatments:

- use of inhaled SABAs (e.g., albuterol/salbutamol) only "as-needed" with no use
of asthma controller medications; OR

- use of stable doses of low- or medium-dose inhaled corticosteroids (ICS), alone,
or in combination with either a long-acting beta-agonist (LABA) or other asthma
controller medications (including leukotriene receptor antagonists) and can
tolerate tapering or discontinuation

- no history of smoking OR no smoking within <1 year with a smoking history of ≤10
pack-years

- ability to maintain a constant day/night, awake/sleep cycle

- agreement to not change habitual consumption of beverages or food containing caffeine
throughout the study

- Body Mass Index (BMI) of 15 to 40 kg/m^2

Exclusion Criteria:

- myocardial infarction, congestive heart failure, or uncontrolled cardiac arrhythmia
within past ≤3 months

- hospitalization within past ≤4 weeks

- major surgical procedure within past ≤4 weeks

- participation in a clinical study involving an investigational drug within past ≤4
weeks

- current regular use or recent (within past ≤5 years) past abuse of alcohol (>14
drinks/week) or illicit drugs

- donation of a unit of blood within past ≤2 weeks or intention to donate a unit of
blood during the study

- evidence of another clinically significant, active pulmonary disorder such as chronic
obstructive pulmonary disease (COPD)

- emergency room treatment for asthma within past ≤4 weeks or hospitalization for
asthma within past ≤8 weeks

- respiratory tract infection requiring antibiotic treatment within past ≤8 weeks

- evidence of active, clinically significant sinus disease within past ≤1 week

- history of a clinically significant psychiatric disorder, other than stable
depression, within past ≤12 weeks

- history of HIV

- hypersensitivity or intolerance to inhaled beta-agonists, leukotriene antagonists,
leukotriene synthesis inhibitors, or any of their ingredients, including lactose and
galactose

- clinically unstable disease of the ophthalmologic, neurological, hepatic, renal,
connective tissue, genitourinary, gastrointestinal, cardiovascular or hematologic
systems

- current cancer or history (within past ≤5 years) of cancer (except for successfully
treated basal and squamous cell carcinomas of the skin); if cancer-free for >5 years,
study participation may be allowed

- evidence of uncontrolled hypertension
We found this trial at
12
sites
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