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

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:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	1475
Study Start Date:	August 2012
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	July 2016 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656395

Contacts

Contact: Toll Free Number

1-888-577-8839

Show 33 Study Locations

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01656395 History of Changes
Other Study ID Numbers:	1029-012, 2012-000643-27
Study First Received:	July 3, 2012
Last Updated:	May 16, 2013
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 May 19, 2013