NCT01624974

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)

Completed Phase 2 Results posted Last updated 2 January 2019

What this trial tests

Phase 2 trial testing MK-1029 in Asthma in 107 participants. Completed in 5 May 2014.

Timeline

9 August 2012

Primary endpoint
5 May 2014

5 May 2014

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	107
Start date	9 August 2012
Primary completion	5 May 2014
Estimated completion	5 May 2014

Drugs / interventions tested

• MK-1029 — full drug profile →
• Placebo
• Montelukast (ML) — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4 Primary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

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 rand

Group	Value	95% CI
MK-1029 + ML	0.065	0.003 – 0.126
Placebo + ML	0.017	-0.044 – 0.078

Adverse Events During Treatment and Follow-up Primary · Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)

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.

Group	Value	95% CI
MK-1029 + ML	30
Placebo + ML	33

Discontinuation of Treatment Due to An Adverse Event Primary · Up to the last dose in Period III or Period V (up to 4 weeks)

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.

Group	Value	95% CI
MK-1029 + ML	2
Placebo + ML	2

Change From Baseline in Daytime Symptom Score (DSS) at Week 4 Secondary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

The change from baseline in DSS at Week 4 following treatment was assessed. Participants used an electronic diary (e-Diary) to enter their asthma symptom scores every evening. Participants scored daily symptoms (chest discomfort, wheezing, shortness of breath, and cough) by responding to 4 questions: 1) Symptom frequency (0 = None of the time, 6 = All of the time); 2) Bothersomeness (0 = Not bothered, 6 = Severely bothered); 3) Activity limitation (0 = Not limited, 6 = Totally limited); 4) Frequency of activity limitation (0 = None of the time, 6 = All of the time). The average of the 4 scores

Baseline

Group	Value	95% CI
MK-1029 + ML	1.93	± 0.91
Placebo + ML	1.98	± 0.90

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	-0.18	± 0.73
Placebo + ML	-0.08	± 0.64

Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4 Secondary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

The change from baseline in SABA use at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants used the e-Diary upon arising and before going to sleep to enter the total number of SABA puffs used for asthma relief. The number of SABA puffs recorded was the number of canister actuations (e. g., when SABA use was required and 3 puffs were inhaled, this was recorded as 3). Participants also recorded the number of nebulizer treatments (1 nebulized SABA use = 3 puffs). The average daily number of puffs for an individual participant was calculated over the week-long asse

Baseline

Group	Value	95% CI
MK-1029 + ML	3.203	± 2.502
Placebo + ML	3.597	± 2.018

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	-0.595	± 1.995
Placebo + ML	-0.561	± 1.768

Change From Baseline in Nocturnal Awakenings at Week 4 Secondary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

The change from baseline in nocturnal awakenings due to asthma at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. The participant scored nocturnal awakenings by answering the question, "Did you wake up with asthma symptoms in the middle of the night or upon awakening in the morning?" (No or Yes). Participants recorded in the e-Diary the number of nights per week in which they awakened with asthma, as determined by dividing the number of nights of awakening with asthma by the total number of nights and then multiplying by 7 (standardized to a 7-day period). The change fro

Baseline

Group	Value	95% CI
MK-1029 + ML	4.97	± 2.60
Placebo + ML	4.90	± 2.62

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	-1.13	± 2.16
Placebo + ML	-1.30	± 2.29

Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4 Secondary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

The change from baseline in AM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed in 97 participants. Participants performed triplicate AM PEF measurements in the morning upon rising. Participants entered all 3 measurements and the greatest AM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average AM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in AM PEF was evaluated using the LDA model with repeated measurement

Baseline

Group	Value	95% CI
MK-1029 + ML	336.57	± 117.02
Placebo + ML	333.07	± 110.65

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	7.14	± 41.86
Placebo + ML	-2.70	± 32.33

Change From Baseline in Evening (PM) PEF at Week 4 Secondary · Baseline (Week 0 and Week 8), Last week of the 4-week treatment period

The change from baseline in PM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants performed triplicate PM PEF measurements in the evening, immediately before study drug administration, at bedtime. Participants entered all 3 measurements and the greatest PM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average PM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in PM PEF was evaluated using the LDA mode

Baseline

Group	Value	95% CI
MK-1029 + ML	350.34	± 121.45
Placebo + ML	342.30	± 115.86

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	8.25	± 42.18
Placebo + ML	-4.68	± 34.47

Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4 Secondary · The week before the first dose in Period III or V (Baseline) and the last week of Period III or V

The change from baseline in the ACQ score at Week 4, after treatment, was assessed in 97 participants. Participants completed 6 items of the ACQ (i. e., ACQ-6) and provided the average of responses over the past week: 1) Frequency of nocturnal awakenings (0 = Never, 6 = Unable to sleep); 2) Symptom severity (0 = None, 6 = Very severe); 3) Activity limitations (0 = Not limited, 6 = Totally limited); 4) Breathlessness (0 = None, 6 = Very great deal); 5) Wheezing (0 = Not at all, 6 = All the time); 6) Daily SABA use (0 = None, 6 = More than 16 puffs on most days). The ACQ score ranges from 0 to 6

Baseline

Group	Value	95% CI
MK-1029 + ML	2.09	± 0.84
Placebo + ML	2.25	± 0.86

Change from Baseline at Week 4

Group	Value	95% CI
MK-1029 + ML	-0.49	± 0.86
Placebo + ML	-0.48	± 0.99

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 days after the last dose in Period III or Period V (up to 6 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MK 1029 + ML

Serious: 0/96 (0%)

Deaths: 0/96

Placebo + ML

Serious: 0/97 (0%)

Deaths: 0/97

Other adverse events (2 terms — click to expand)

Reaction	System	MK 1029 + ML	Placebo + ML
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT01624974 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.