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 |
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.
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
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials