Trial Outcomes & Findings for 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) (NCT NCT01624974)
NCT ID: NCT01624974
Last Updated: 2019-01-02
Results Overview
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.
COMPLETED
PHASE2
107 participants
The week before the first dose in Period III or V (Baseline) and the last week of Period III or V
2019-01-02
Participant Flow
Period I (443 participants) was a Pre-study screening period. Period II (186 participants) was a Run-in period in which participants received open-label montelukast (ML) 10 mg and matching single-blind placebo once daily (QD). Whereas 443 participants were screened, 107 eligible participants were enrolled and randomized to treatment in Period III.
Participant milestones
| Measure |
MK-1029 + ML → Placebo + ML
Participants received 4 weeks of MK-1029 150 mg QD + ML 10 mg QD in Period III and Placebo + 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.
|
Placebo + ML → MK-1029 + ML
Participants received 4 weeks of 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.
|
|---|---|---|
|
Period III of Treatment (4 Weeks)
STARTED
|
54
|
53
|
|
Period III of Treatment (4 Weeks)
COMPLETED
|
47
|
45
|
|
Period III of Treatment (4 Weeks)
NOT COMPLETED
|
7
|
8
|
|
Period IV Washout (4 Weeks)
STARTED
|
47
|
45
|
|
Period IV Washout (4 Weeks)
COMPLETED
|
44
|
42
|
|
Period IV Washout (4 Weeks)
NOT COMPLETED
|
3
|
3
|
|
Period V of Treatment (4 Weeks)
STARTED
|
44
|
42
|
|
Period V of Treatment (4 Weeks)
COMPLETED
|
39
|
42
|
|
Period V of Treatment (4 Weeks)
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
MK-1029 + ML → Placebo + ML
Participants received 4 weeks of MK-1029 150 mg QD + ML 10 mg QD in Period III and Placebo + 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.
|
Placebo + ML → MK-1029 + ML
Participants received 4 weeks of 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.
|
|---|---|---|
|
Period III of Treatment (4 Weeks)
Lack of Efficacy
|
0
|
2
|
|
Period III of Treatment (4 Weeks)
Non-Compliance with Protocol
|
1
|
2
|
|
Period III of Treatment (4 Weeks)
Physician Decision
|
5
|
3
|
|
Period III of Treatment (4 Weeks)
Protocol Violation
|
1
|
0
|
|
Period III of Treatment (4 Weeks)
Adverse Event
|
0
|
1
|
|
Period IV Washout (4 Weeks)
Lack of Efficacy
|
1
|
1
|
|
Period IV Washout (4 Weeks)
Withdrawal by Subject
|
0
|
1
|
|
Period IV Washout (4 Weeks)
Adverse Event
|
2
|
0
|
|
Period IV Washout (4 Weeks)
Non-Compliance with Study Drug
|
0
|
1
|
|
Period V of Treatment (4 Weeks)
Lack of Efficacy
|
1
|
0
|
|
Period V of Treatment (4 Weeks)
Physician Decision
|
3
|
0
|
|
Period V of Treatment (4 Weeks)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Baseline was predose on the first day of treatment Period III
Baseline characteristics by cohort
| Measure |
MK-1029 150 mg + ML → Placebo + ML
n=54 Participants
Participants received 4 weeks of MK-1029 150 mg QD + ML 10 mg QD in Period III and Placebo + 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
|
Placebo + ML → MK-1029 150 mg + ML
n=53 Participants
Participants received 4 weeks of 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
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 Years
STANDARD_DEVIATION 11.2 • n=39 Participants
|
39.1 Years
STANDARD_DEVIATION 13.5 • n=41 Participants
|
40.4 Years
STANDARD_DEVIATION 12.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
73 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
64 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
41 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Forced Expiratory Volume in One Second (FEV1)
|
2.333 Liters
STANDARD_DEVIATION 0.637 • n=39 Participants • Baseline was predose on the first day of treatment Period III
|
2.243 Liters
STANDARD_DEVIATION 0.600 • n=41 Participants • Baseline was predose on the first day of treatment Period III
|
2.289 Liters
STANDARD_DEVIATION 0.618 • n=35 Participants • Baseline was predose on the first day of treatment Period III
|
PRIMARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis, as well as a pre-dose baseline measurement.
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.
Outcome measures
| Measure |
MK-1029 + ML
n=93 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=97 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4
|
0.065 Liters
Interval 0.003 to 0.126
|
0.017 Liters
Interval -0.044 to 0.078
|
PRIMARY outcome
Timeframe: Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)Population: All randomized participants who received at least one dose of study treatment and had 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.
Outcome measures
| Measure |
MK-1029 + ML
n=96 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=97 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Adverse Events During Treatment and Follow-up
|
30 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Up to the last dose in Period III or Period V (up to 4 weeks)Population: All randomized participants who received at least one dose of study treatment and had follow-up.
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.
Outcome measures
| Measure |
MK-1029 + ML
n=96 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=97 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Discontinuation of Treatment Due to An Adverse Event
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.
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 for overall DSS ranges from 0 to 6 where a higher average indicates greater symptom severity. The average overall DSS was calculated over the week-long assessment periods. The change from baseline in DSS was evaluated using the LDA model with repeated measurements of DSS, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=91 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=97 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Daytime Symptom Score (DSS) at Week 4
Baseline
|
1.93 Score on a scale
Standard Deviation 0.91
|
1.98 Score on a scale
Standard Deviation 0.90
|
|
Change From Baseline in Daytime Symptom Score (DSS) at Week 4
Change from Baseline at Week 4
|
-0.18 Score on a scale
Standard Deviation 0.73
|
-0.08 Score on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 98 measurements from 97 participants.
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 assessment periods. The change from baseline in SABA use was evaluated using the LDA model with repeated measurements of SABA use, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=94 SABA Use Measurements
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=98 SABA Use Measurements
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
Baseline
|
3.203 Number of puffs
Standard Deviation 2.502
|
3.597 Number of puffs
Standard Deviation 2.018
|
|
Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4
Change from Baseline at Week 4
|
-0.595 Number of puffs
Standard Deviation 1.995
|
-0.561 Number of puffs
Standard Deviation 1.768
|
SECONDARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.
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 from baseline in nocturnal awakenings was evaluated using the LDA model with repeated measurements of nocturnal awakenings, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=69 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=74 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Nocturnal Awakenings at Week 4
Baseline
|
4.97 Number of nocturnal awakenings
Standard Deviation 2.60
|
4.90 Number of nocturnal awakenings
Standard Deviation 2.62
|
|
Change From Baseline in Nocturnal Awakenings at Week 4
Change from Baseline at Week 4
|
-1.13 Number of nocturnal awakenings
Standard Deviation 2.16
|
-1.30 Number of nocturnal awakenings
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 98 measurements from 97 participants.
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 measurements of AM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=93 AM PEF Measurements
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=98 AM PEF Measurements
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
Baseline
|
336.57 Liters/min
Standard Deviation 117.02
|
333.07 Liters/min
Standard Deviation 110.65
|
|
Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4
Change from Baseline at Week 4
|
7.14 Liters/min
Standard Deviation 41.86
|
-2.70 Liters/min
Standard Deviation 32.33
|
SECONDARY outcome
Timeframe: Baseline (Week 0 and Week 8), Last week of the 4-week treatment periodPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.
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 model with repeated measurements of PM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=91 Participants
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=96 Participants
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Evening (PM) PEF at Week 4
Baseline
|
350.34 Liters/min
Standard Deviation 121.45
|
342.30 Liters/min
Standard Deviation 115.86
|
|
Change From Baseline in Evening (PM) PEF at Week 4
Change from Baseline at Week 4
|
8.25 Liters/min
Standard Deviation 42.18
|
-4.68 Liters/min
Standard Deviation 34.47
|
SECONDARY outcome
Timeframe: The week before the first dose in Period III or V (Baseline) and the last week of Period III or VPopulation: All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 99 measurements from 97 participants.
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 where a lower score indicates greater performance. The investigator reviewed the participant-completed ACQ-6 to ensure its completeness. The change from baseline in the ACQ score was evaluated using the LDA model with repeated measurements of the ACQ score, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.
Outcome measures
| Measure |
MK-1029 + ML
n=97 ACQ Measurements
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or V. Period IV was a 4-week washout period during which participants received single-blind Placebo QD and open-label ML 10 mg QD
|
Placebo + ML
n=99 ACQ Measurements
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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
|
|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
Baseline
|
2.09 Score on a scale
Standard Deviation 0.84
|
2.25 Score on a scale
Standard Deviation 0.86
|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4
Change from Baseline at Week 4
|
-0.49 Score on a scale
Standard Deviation 0.86
|
-0.48 Score on a scale
Standard Deviation 0.99
|
Adverse Events
MK 1029 + ML
Placebo + ML
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MK 1029 + ML
n=96 participants at risk
Participants received 4 weeks treatment with MK-1029 150 mg QD + ML 10 mg QD in Period III or 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.
|
Placebo + ML
n=97 participants at risk
Participants received 4 weeks treatment with Placebo QD + ML 10 mg QD in Period III or 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.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.3%
8/96 • Number of events 9 • Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
|
8.2%
8/97 • Number of events 8 • Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
7.3%
7/96 • Number of events 7 • Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
|
9.3%
9/97 • Number of events 10 • Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee This study is intended for publication, even if terminated prematurely. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER