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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01656395
First received: July 3, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: MK-1029 10 mg
Drug: MK-1029 30 mg
Drug: MK-1029 150 mg
Drug: Montelukast 10 mg
Drug: Placebo
Drug: MK-1029 1 mg or 3 mg
Drug: Montelukast 10 mg + MK-1029
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects With Persistent Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Average Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience Adverse Events (AEs) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Discontinue Due to AEs [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of Days with Asthma Exacerbations [ Time Frame: Last 6 weeks of treatment ] [ Designated as safety issue: No ]
  • Average Change from Baseline in Daytime Symptom Score [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Average Change from Baseline in Use of Short-Acting Beta-Agonists (SABAs) [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Average Change from Baseline in Number of Nocturnal Awakenings [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Average Change from Baseline in Morning (AM) Peak Expiratory Flow (PEF) [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Average Change from Baseline in Night (PM) Peak Expiratory Flow (PEF) [ Time Frame: Baseline and last six weeks of treatment ] [ Designated as safety issue: No ]
  • Change from Baseline in Asthma Quality of Life Questionnaire with Standardised Activities [AQLQ(S)] Overall and Domain Scores [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants with a ≥0.5 Decrease in AQLQ(S) Overall and Domain Scores from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Asthma Control Questionnaire (ACQ) Score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants with a ≥0.5 decrease in ACQ Score from Baseline [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants with Asthma Attacks [ Time Frame: 12 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 557
Study Start Date: August 2012
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1029 10 mg Drug: MK-1029 10 mg
Parts I-II: Participants will receive MK-1029 10 mg tablets taken once daily (QD)
Experimental: MK-1029 30 mg Drug: MK-1029 30 mg
Parts I-II: Participants will receive MK-1029 30 mg tablets QD
Experimental: MK-1029 60 mg Drug: MK-1029 30 mg
Parts I-II: Participants will receive MK-1029 30 mg tablets QD
Experimental: MK-1029 150 mg Drug: MK-1029 150 mg
Parts I-II: Participants will receive MK-1029 150 mg tablets QD
Active Comparator: Montelukast 10 mg Drug: Montelukast 10 mg
Parts I-II: Participants will receive Montelukast 10 mg tablets QD
Other Name: SINGULAIR®
Placebo Comparator: Placebo Drug: Placebo
Parts I-II: Participants will receive Placebo tablets QD
Experimental: MK-1029 1 mg or 3 mg Drug: MK-1029 1 mg or 3 mg
Part II: Participants will receive either MK-1029 1 mg or 3 mg tablets (dose to be determined based on results of interim analysis from Part I) QD.
Experimental: Montelukast 10 mg + MK-1029 Drug: Montelukast 10 mg + MK-1029
Part II: Participants will receive Montelukast 10 mg tablets QD and MK-1029 tablets (dose to be determined based on results of interim analysis from Part I) QD
Other Name: SINGULAIR®

  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 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
  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: NCT01656395     History of Changes
Other Study ID Numbers: 1029-012, 2012-000643-27
Study First Received: July 3, 2012
Last Updated: August 21, 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
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014