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)

NCT01624974 | Completed Phase 2 Results

• 3 other identifiers: 1029-0112012-000642-35MK-1029-011
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. The primary hypothesis is that MK-1029 is superior to placebo in change from baseline in forced expiratory volume in one second (FEV1) at the end of the 4-week treatment period.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4

  The change from baseline in FEV1 at Week 4 following treatment with MK-1029 + ML or placebo + ML was assessed. The pre-bronchodilator FEV1 was evaluated to assess the response to treatment for asthma. The primary efficacy evaluation period was the last week of each treatment period: Period III (Initial Therapy, Week 4) and Period V (Crossover Therapy, Week 4). The change from baseline in FEV1 was evaluated using a longitudinal data analysis (LDA) model with repeated measurements of FEV1, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. Baseline FEV1 is defined as the measurement taken before dosing in each treatment period (i. e., at Visit 3 \[Week 0\], prior to Period III and at Visit 6 \[Week 8\], prior to Period V). The Baseline Characteristics section shows FEV1 values at baseline.

  The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

• Adverse Events During Treatment and Follow-up

  The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants with at least one AE was assessed. The number of participants in any treatment group with at least one AE was assessed.

  Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)

• Discontinuation of Treatment Due to An Adverse Event

  The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.

  Up to the last dose in Period III or Period V (up to 4 weeks)

Secondary Outcomes (6)

• Change From Baseline in Daytime Symptom Score (DSS) at Week 4

  The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

• Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4

  The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

• Change From Baseline in Nocturnal Awakenings at Week 4

  The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

• Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4

  The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

• Change From Baseline in Evening (PM) PEF at Week 4

  Baseline (Week 0 and Week 8), Last week of the 4-week treatment period

Study Arms (2)

MK-1029/Placebo

EXPERIMENTAL

Participants received 4 weeks treatment with MK-1029 150 mg once daily (QD) + ML 10 mg QD in Period III and Placebo QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.

Drug: MK-1029; Drug: Placebo; Drug: Montelukast (ML)

Placebo/MK-1029

EXPERIMENTAL

Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III and MK-1029 150 mg QD + ML 10 mg QD in Period V. Period IV was a 4-week wash-out period during which participants received single-blind Placebo QD and open-label ML 10 mg QD.

Drug: MK-1029; Drug: Placebo; Drug: Montelukast (ML)

Interventions

MK-1029 DRUG

MK-1029 150 mg tablets taken QD

MK-1029/Placebo; Placebo/MK-1029

Placebo DRUG

Placebo tablets (matching the MK-1029 150 mg tablets) QD

MK-1029/Placebo; Placebo/MK-1029

Montelukast (ML) DRUG

ML 10 mg tablets QD

MK-1029/Placebo; Placebo/MK-1029

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: August 9, 2012
• Primary Completion: May 5, 2014
• Study Completion: May 5, 2014
• Last Updated: January 2, 2019
• Results First Posted: November 23, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share