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 AM2)
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 1/1/2014 |
Start Date: | August 2012 |
End Date: | May 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Crossover Study of MK-1029 in Adult Subjects With Persistent Asthma Who Remain Uncontrolled While Being Maintained on Montelukast
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.
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.
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.
We found this trial at
12
sites
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