Trial · NCT02720081
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
NCT02720081, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2018-08-28
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015). Trials, record NCT02720081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02720081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
- NCT number
- NCT02720081
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 142 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Asthma
- Interventions
- MK-1029 150 mg, MK-1029 Matching-image Placebo, Montelukast 10 mg, Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
- First posted
- 2016-03-25
- Last updated
- 2018-09-27
- Other registries' IDs
- eudract:2015-005054-36
- Results first posted
- 2018-08-28
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before the first dose of study investigational product (Baseline) | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. |
| Primary | Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6 | Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment | FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6. |
| Secondary | Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | Up to 4 weeks | A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake "all night"; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing. |
| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to 8 weeks | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 6 weeks | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Bilirubin at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
| Secondary | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline and Week 6 | Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | Before the first dose of study investigational product (Baseline) | Analysis population consists of randomized participants who received at least 1 dose of study drug. | Liter | MEAN |
| SECONDARY | Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | Up to 4 weeks | Analysis population consists of randomized participants who received at least 1 dose of study drug and had at least 80% of days with a complete diary during Weeks 3 to 6 (a diary is considered complete if none of the 6 components used to determine asthma worsening are missing). | Percentage of days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Experienced an Adverse Event (AE) | Up to 8 weeks | Analysis population included all randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 6 weeks | Analysis population included all randomized participants who received at least 1 dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALP. | IU/L | MEAN |
| SECONDARY | Change From Baseline in Alanine Aminotransferase (ALT) at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALT. | IU/L | MEAN |
| SECONDARY | Change From Baseline in Aspartate Aminotransferase (AST) at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, AST. | IU/L | MEAN |
| SECONDARY | Change From Baseline in Bilirubin at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, bilirubin. | mg/dL | MEAN |
| SECONDARY | Change From Baseline in Eosinophil (Percent [%]) at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, eosinophil (%). | Percent of White Blood Cells | MEAN |
| SECONDARY | Change From Baseline in Neutrophil (%) at Week 6 | Baseline and Week 6 | Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, neutrophil (%). | Percent of White Blood Cells | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | MK-1029 150 mg + Montelukast 10 mg | 2.264 | Standard Deviation 0.566 | Liter | |
| Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1) | MK-1029 Placebo + Montelukast 10 mg | 2.234 | Standard Deviation 0.612 | Liter | |
| Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | MK-1029 150 mg + Montelukast 10 mg | 16.970 | 95% Confidence Interval 10.115 to 23.826 | Percentage of days | |
| Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6 | MK-1029 Placebo + Montelukast 10 mg | 21.746 | 95% Confidence Interval 14.291 to 29.201 | Percentage of days | |
| Percentage of Participants Who Experienced an Adverse Event (AE) | MK-1029 150 mg + Montelukast 10 mg | 25.7 | Percentage of participants | ||
| Percentage of Participants Who Experienced an Adverse Event (AE) | MK-1029 Placebo + Montelukast 10 mg | 26.1 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an AE | MK-1029 150 mg + Montelukast 10 mg | 0.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an AE | MK-1029 Placebo + Montelukast 10 mg | 4.3 | Percentage of participants | ||
| Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | MK-1029 150 mg + Montelukast 10 mg | Baseline | 61.16 | Standard Deviation 19.05 | IU/L |
| Change From Baseline in Alkaline Phosphatase (ALP) at Week 6 | MK-1029 Placebo + Montelukast 10 mg | Baseline | 67.96 | Standard Deviation 21.17 | IU/L |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-1029 150 mg + Montelukast 10 mg | 72 | |
| Overall Study | STARTED | MK-1029 Placebo + Montelukast 10 mg | 70 | |
| Overall Study | Treated | MK-1029 150 mg + Montelukast 10 mg | 70 | |
| Overall Study | Treated | MK-1029 Placebo + Montelukast 10 mg | 69 | |
| Overall Study | COMPLETED | MK-1029 150 mg + Montelukast 10 mg | 68 | |
| Overall Study | COMPLETED | MK-1029 Placebo + Montelukast 10 mg | 66 | |
| Overall Study | NOT COMPLETED | MK-1029 150 mg + Montelukast 10 mg | 4 | |
| Overall Study | NOT COMPLETED | MK-1029 Placebo + Montelukast 10 mg | 4 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | MK-1029 150 mg + Montelukast 10 mg | 1 | 70 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | MK-1029 Placebo + Montelukast 10 mg | 4 | 69 | 5 |
| other | Viral upper respiratory tract infection | Infections and infestations | MK-1029 150 mg + Montelukast 10 mg | 4 | 70 | 4 |
| other | Viral upper respiratory tract infection | Infections and infestations | MK-1029 Placebo + Montelukast 10 mg | 0 | 69 | 0 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | MK-1029 150 mg + Montelukast 10 mg | 2 | 70 | 2 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | MK-1029 Placebo + Montelukast 10 mg | 8 | 69 | 8 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | MK-1029 150 mg + Montelukast 10 mg | 0 | 70 | 0 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | MK-1029 Placebo + Montelukast 10 mg | 1 | 69 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-1029 150 mg + Montelukast 10 mg | 0 | 70 |
| Total, all-cause mortality | MK-1029 Placebo + Montelukast 10 mg | 0 | 69 |
| Total, other adverse events | MK-1029 150 mg + Montelukast 10 mg | 6 | 70 |
| Total, other adverse events | MK-1029 Placebo + Montelukast 10 mg | 9 | 69 |
| Total, serious adverse events | MK-1029 150 mg + Montelukast 10 mg | 0 | 70 |
| Total, serious adverse events | MK-1029 Placebo + Montelukast 10 mg | 1 | 69 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MK-1029 150 mg + Montelukast 10 mg vs MK-1029 Placebo + Montelukast 10 mg: deaths from any cause | Trial comparisons |
| MK-1029 150 mg + Montelukast 10 mg vs MK-1029 Placebo + Montelukast 10 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02720081
GET https://conductscience.org/api/trials/v1/NCT02720081/registered?page=2