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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01624974
First received: June 19, 2012
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: MK-1029
Drug: placebo
Drug: montelukast (ML)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change in Forced Expiratory Volume in one second (FEV1) [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Daytime Symptom Score [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]
  • Change in Use of Short-Acting Beta-Agonists (SABAs) [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]
  • Change in Number of Nocturnal Awakenings [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]
  • Change in AM Peak Expiratory Flow (PEF) [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]
  • Change in PM Peak Expiratory Flow (PEF) [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]
  • Change in Asthma Control Questionnaire (ACQ) Score [ Time Frame: before first dose and after last dose of study drug during a 4-week treatment period ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: August 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1029/placebo
Participants assigned to receive MK-1029 during the first treatment period and placebo during the second treatment period.
Drug: MK-1029
MK-1029 150 mg tablets taken once daily (QD)
Drug: placebo
placebo tablets (matching the MK-1029 150 mg tablets) QD
Drug: montelukast (ML)
ML 10 mg tablets QD
Experimental: placebo/MK-1029
Participants assigned to receive placebo during the first treatment period and MK-1029 during the second treatment period.
Drug: MK-1029
MK-1029 150 mg tablets taken once daily (QD)
Drug: placebo
placebo tablets (matching the MK-1029 150 mg tablets) QD
Drug: montelukast (ML)
ML 10 mg tablets QD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01624974     History of Changes
Other Study ID Numbers: 1029-011, 2012-000642-35
Study First Received: June 19, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014