This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results 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) (NCT01624974), a randomized phase 2 study. The primary outcome is Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01624974 |
| Phase | Phase 2 |
| Condition | Asthma |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Double |
| Enrollment | 107 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
Adults with persistent asthma who remained uncontrolled while being maintained on montelukast. The primary-outcome analysis included randomized participants who received at least one dose of study treatment in a crossover period, had at least one outcome measurement, and had a pre-dose baseline measurement.
Intervention
MK-1029 150 mg once daily, taken with montelukast 10 mg once daily, during a 4-week treatment period.
Comparator
Placebo once daily with montelukast 10 mg once daily during the other 4-week treatment period. Participants crossed over between the active-treatment and placebo combinations.
Primary question
Did the change from baseline in pre-bronchodilator FEV1 at Week 4 differ between MK-1029 plus montelukast and placebo plus montelukast?
The trial focused on a lung-function measure in adults whose asthma was not controlled with montelukast. Both treatment conditions included montelukast, so the comparison concerns adding MK-1029 rather than comparing montelukast with no treatment. Participants received each assigned study-drug condition in separate treatment periods, with a wash-out period between them.
The registry identifies superiority over placebo as the primary hypothesis. The posted estimate for the difference in least-squares mean change was 0.047 liters, favoring the MK-1029 combination numerically. Its 95% confidence interval ranged from -0.039 to 0.134 liters, and the reported p-value was 0.282. The interval includes zero, so the estimated difference is compatible with no difference as well as with effects in either direction within the interval. The result does not establish superiority in this analysis.
3. Trial Design
The registry describes a randomized, double-blind, placebo-controlled, multicenter crossover study, marked as phase 2, in adults with persistent asthma who remained uncontrolled while maintained on montelukast. Enrollment was 107, and the study status is completed. The recorded start date is 2012-08-09, and primary completion is recorded as 2014-05-05.
Participants followed one of two treatment sequences. In one sequence, MK-1029 150 mg once daily with montelukast 10 mg once daily was given in Period III, followed by placebo with montelukast in Period V. In the other sequence, placebo with montelukast was given first and MK-1029 with montelukast second. Each of these treatment periods lasted 4 weeks. Period IV, between the treatment periods, was a 4-week wash-out period during which participants received single-blind placebo once daily and open-label montelukast 10 mg once daily.
The crossover structure means that participants were assigned to a sequence and experienced both study-drug conditions, rather than remaining in only one parallel treatment group. The within-participant structure can allow each participant's measurements under the two conditions to inform the comparison. The analysis also has to account for the period in which a measurement was made and for repeated measurements over time.
The primary efficacy period was the last week of each treatment period. Baseline was defined separately before each treatment period: before Period III and before Period V. The registry's primary-outcome population required receipt of at least one dose in a crossover period, at least one measurement for the outcome analysis, and a pre-dose baseline measurement. Details such as the randomization procedure, concealment process, and any further protocol features are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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.
Period III of Treatment (4 Weeks)
| Stage | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| STARTED | 54 | 53 |
| COMPLETED | 47 | 45 |
| NOT COMPLETED | 7 | 8 |
Reasons for not completing this period:
| Reason | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| Lack of Efficacy | 0 | 2 |
| Non-Compliance with Protocol | 1 | 2 |
| Physician Decision | 5 | 3 |
| Protocol Violation | 1 | 0 |
| Adverse Event | 0 | 1 |
Period IV Washout (4 Weeks)
| Stage | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| STARTED | 47 | 45 |
| COMPLETED | 44 | 42 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| Lack of Efficacy | 1 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Adverse Event | 2 | 0 |
| Non-Compliance with Study Drug | 0 | 1 |
Period V of Treatment (4 Weeks)
| Stage | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| STARTED | 44 | 42 |
| COMPLETED | 39 | 42 |
| NOT COMPLETED | 5 | 0 |
Reasons for not completing this period:
| Reason | MK-1029 + ML → Placebo + ML | Placebo + ML → MK-1029 + ML |
|---|---|---|
| Lack of Efficacy | 1 | 0 |
| Physician Decision | 3 | 0 |
| Adverse Event | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | MK-1029 150 mg + ML → Placebo + ML | Placebo + ML → MK-1029 150 mg + ML | Total |
|---|---|---|---|---|
| Participants analysed | 54 | 53 | 107 | |
| Age, Continuous | Years | 41.6 (SD 11.2) | 39.1 (SD 13.5) | 40.4 (SD 12.4) |
| Sex: Female, Male: Female | Participants | 35 | 38 | 73 |
| Sex: Female, Male: Male | Participants | 19 | 15 | 34 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 34 | 30 | 64 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 | 23 | 43 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 4 | 2 | 6 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 19 | 22 | 41 |
| Race (NIH/OMB): More than one race | Participants | 29 | 28 | 57 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Forced Expiratory Volume in One Second (FEV1) | Liters | 2.333 (SD 0.637) | 2.243 (SD 0.600) | 2.289 (SD 0.618) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4, measured over The week before the first dose in Period III or V (Baseline) and the last week of Period III or V.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Liters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in forced expiratory volume in one second, or FEV1, at Week 4. FEV1 is the volume of air a person can forcefully exhale during the first second of an exhalation. The registry reports the measure in liters and specifies that pre-bronchodilator FEV1 was used to assess response to treatment for asthma.
Baseline was the measurement taken before dosing in the relevant treatment period: before Period III for the initial treatment and before Period V for the crossover treatment. Change was assessed in the last week of each 4-week treatment period. Defining a separate baseline for each period allows the analysis to compare change from the participant's starting measurement for that treatment period.
FEV1 is a continuous measure of lung function. A change score describes how the measurement differs from its corresponding baseline; the least-squares means are model-based estimates rather than simple raw averages. The primary comparison is the difference between those estimated changes under MK-1029 plus montelukast and placebo plus montelukast.
Using a lung-function endpoint makes the primary question about a measured physiological outcome. It does not, by itself, summarize every aspect of asthma control or the participant's experience. The registry also lists secondary outcomes involving daytime symptoms, short-acting beta agonist use, nocturnal awakenings, morning and evening peak expiratory flow, and asthma control questionnaire score. Those outcomes address other dimensions, but the primary efficacy conclusion is based on the FEV1 comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a least-squares mean change in FEV1 of 0.065 liters for MK-1029 plus montelukast, with a 95% confidence interval from 0.003 to 0.126. For placebo plus montelukast, the reported change was 0.017 liters, with a 95% confidence interval from -0.044 to 0.078. The sponsor's LDA comparison is a difference in least-squares means of 0.047 liters, with a 95% confidence interval from -0.039 to 0.134 and p = 0.282.
The point estimate is positive: the model-estimated change was greater in the MK-1029 condition than in the placebo condition. But the interval around the difference includes zero. It also extends to values on either side of zero, so the estimate is not precise enough to distinguish a positive difference from no difference or a negative difference at the conventional two-sided 0.05 significance level. The p-value of 0.282 likewise does not meet that threshold. Taken together, the reported comparison does not establish the prespecified superiority hypothesis.
The confidence interval communicates uncertainty in the estimated difference. It is not a range in which every value is equally likely, and it does not indicate that the true difference has a 95% probability of lying within the particular interval. In general, a 95% confidence interval is produced by a procedure that, under its assumptions and repeated use, would contain the target value in 95% of such intervals. Its breadth leaves appreciable uncertainty about the size and direction of the treatment contrast.
The individual condition estimates should not be confused with the randomized treatment comparison. Their confidence intervals describe estimated change within each treatment condition; the primary inferential question concerns the difference between conditions. The model-based difference is reported directly by the registry as 0.047 liters. It is therefore the appropriate statistic to use for the superiority question, rather than drawing a conclusion by looking only at whether either condition's separate interval includes zero.
The reported outcome analysis included 93 participants in the MK-1029 plus montelukast condition and 97 in the placebo plus montelukast condition. These are analysis counts for the crossover outcome estimates, not separate parallel groups of participants. The registry defines the analysis population by treatment receipt and availability of outcome and baseline measurements. Interpretation therefore applies to the analyzed observations under that definition, and not automatically to every randomized participant.
The finding is a statistical result for this endpoint and analysis. It does not establish whether the observed point estimate is important to patients, and the registry record does not state a threshold for clinical importance. Nor does a non-significant result prove equivalence or show that the treatment conditions have exactly the same effect. The data leave uncertainty; they do not support a claim of established superiority in this primary comparison.
9. Statistical Methods Explained
The primary outcome was analyzed with a longitudinal data analysis (LDA) model using repeated FEV1 measurements. The registry states that treatment, visit, the treatment-by-visit interaction, and period were included as fixed effects, with participant as a random effect. The reported primary comparison is the difference in least-squares means, with a 95% confidence interval and a p-value.
Why use a repeated-measures model?
General statistical explanation: repeated measurements from the same participant tend to be related rather than independent. A model that recognizes this relationship can use the pattern of measurements over time while accounting for participant-level variation. Treating every recorded measurement as if it came from a different person would ignore that structure and could misstate uncertainty.
In this crossover trial, the model also includes period. Period III and Period V correspond to different treatment periods, and a participant's baseline was measured before each of them. Including period allows the analysis to account for systematic differences associated with the treatment period. Treatment-by-visit interaction allows the estimated treatment contrast to vary by visit, rather than requiring a single identical contrast at every measurement time. These are general interpretations of the model terms; further implementation details are not reported in the registry record.
What are least-squares means?
General statistical explanation: least-squares means are model-adjusted estimates of an outcome for specified treatment conditions. They are calculated from the fitted model, with its included terms, rather than being simple arithmetic means of all observed values. The reported difference of 0.047 liters is the model's estimated contrast between the treatment conditions. Because it comes from the fitted LDA model, it is not necessarily identical to a subtraction of the two displayed condition estimates after rounding.
A confidence interval describes uncertainty around that estimated contrast. Here the 95% interval runs from -0.039 to 0.134 liters. Since zero lies within that interval, the results are compatible with no difference under the model and its assumptions. The interval also permits a range of positive or negative differences. A point estimate alone would obscure that uncertainty.
How should the p-value be read?
General statistical explanation: a p-value measures how unusual results at least as incompatible with a specified null hypothesis would be, if that hypothesis and the statistical model were correct. It is not the probability that the null hypothesis is true, nor a measure of the probability that the result arose by chance. The reported p-value is 0.282. The registry's superiority comparison therefore does not meet the conventional two-sided 0.05 threshold described in the planning assumptions.
The model's repeated-measure structure is relevant to precision because it uses measurements from the crossover periods and accounts for participant-level variation. The amount of information gained from repeated observations depends on their pattern and correlation, as well as on missingness and other model assumptions. The registry record does not report enough detail to independently assess all such features, including the covariance structure, estimation procedure, or diagnostics.
Why can over-dispersion matter?
General statistical explanation: over-dispersion arises when variability in observed data is greater than a model's assumptions allow. It is especially discussed for count outcomes, where underestimated variability can make confidence intervals too narrow and p-values too small. The primary endpoint is continuous FEV1, and the registry describes an LDA model; it does not report an over-dispersion assessment. The broader lesson is that uncertainty estimates depend on whether a model represents the data adequately, but no additional model check can be inferred from the posted record.
The registry identifies the population used for this outcome: randomized participants who received at least one dose of study treatment in a crossover period, had at least one measurement for outcome analysis, and had a pre-dose baseline. That rule is part of how the reported estimates should be understood. The record does not give a full account of how missing measurements were handled in the model, whether assumptions about missingness were assessed, or whether sensitivity analyses were performed. Those details affect how far the model-based inference can be generalized beyond the observed analysis data.
Finally, a superiority test addresses whether the data provide evidence for a difference in the specified direction under the chosen analysis. It is not an equivalence test or a non-inferiority test. No equivalence margin or non-inferiority margin is reported in the registry record, and the fact that the confidence interval includes zero does not establish equivalence.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| LDA model | Difference in Least Squares (LS) Means 0.047 | -0.039 to 0.134 | 0.282 |
The registry's primary comparison is the sponsor's reported LDA analysis: a difference in least-squares means of 0.047 liters, a 95% confidence interval from -0.039 to 0.134, and p = 0.282. This is the inferential result to use when describing the study's primary outcome. The registry does not report a separate recalculated two-arm comparison for this continuous endpoint; the record indicates that values were missing or not estimable for that kind of recalculation.
The condition estimates are also posted: 0.065 liters for MK-1029 plus montelukast and 0.017 liters for placebo plus montelukast. They are not a substitute for the fitted crossover comparison. In particular, a difference formed from displayed, rounded condition estimates would be an unadjusted calculation and would not reproduce the LDA model's treatment contrast. The registry's reported contrast incorporates its stated model terms and should take precedence over any simple reconstruction.
The discrepancy flag is false, so there is no indicated conflict between a sponsor result and a recalculated value. No independent recalculated estimate is available for comparison in this record. Accordingly, interpretation rests on the reported model estimate and its uncertainty, without implying that an independent analysis verified it.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists six secondary outcomes: change from baseline in daytime symptom score, short-acting beta agonist use, nocturnal awakenings, morning peak expiratory flow, evening peak expiratory flow, and asthma control questionnaire score, each at Week 4. It also records nine outcome measures and one analysis. The primary endpoint is the FEV1 change comparison; the secondary outcomes address other measures of symptoms, medication use, airflow, and asthma control.
Testing several outcomes can increase the chance of obtaining at least one statistically notable result even when no treatment effect exists. General statistical explanation: multiplicity procedures control or otherwise address this issue by adjusting the inferential threshold, defining a testing sequence, or limiting which comparisons are confirmatory. Whether such an approach was planned or used for the primary and secondary outcomes is not reported in the registry record. The record also does not report the results for the secondary outcomes in the registry record for this analysis, so no conclusions about those outcomes can be drawn.
The primary analysis population was not simply defined as every randomized participant. It included randomized participants who received at least one dose in a crossover period, had at least one outcome measurement, and had a pre-dose baseline measurement. This makes clear which general group the primary estimate represents, while also excluding participants who did not meet those analysis requirements.
The registry describes the model and the outcome population, but further missing-data details are not reported in the registry record. In particular, it does not state how incomplete repeated measurements were handled, what assumptions were made about why data might be missing, or whether sensitivity analyses examined alternative assumptions. The record also does not report interim analyses, a detailed statistical analysis plan, or a sample-size justification. These absences limit assessment of how the planned testing strategy and missing-data procedures relate to the reported estimate; they do not establish that any particular procedure was or was not used.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| MK 1029 + ML | 0 | 96 | 0.0% |
| Placebo + ML | 0 | 97 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MK 1029 + ML | 0 of 96 |
| Placebo + ML | 0 of 97 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| MK 1029 + ML | 14 of 96 |
| Placebo + ML | 14 of 97 |
Most frequent non-serious adverse event terms
| Event term | Organ system | MK 1029 + ML | Placebo + ML |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 8 of 96 | 8 of 97 |
| Asthma | Respiratory, thoracic and mediastinal disorders | 7 of 96 | 9 of 97 |
The posted serious adverse event figures show 0 serious adverse events among 96 participants at risk in the MK 1029 plus montelukast group, and 0 among 97 participants at risk in the placebo plus montelukast group. The registry lists no serious adverse event terms. Deaths are recorded as 0 in each group.
These are the serious adverse event counts recorded for the groups and risk sets shown in the registry. A zero count means that no serious adverse events were recorded in those groups during the reported safety assessment; it does not establish that the risk is absent. With no events recorded, these figures alone cannot describe the full range of possible event rates or rule out uncommon harms.
The registry also reports other adverse events affecting 14 participants at risk in the MK 1029 plus montelukast group and 14 in the placebo plus montelukast group. These are separate from the serious adverse event counts and should not be read as serious-event counts. The record does not provide the terms for serious adverse events because none are listed, and the registry entries do not include detailed descriptions of the other adverse events.
Because this is a crossover study with two treatment conditions, the posted safety group counts should be read as the registry records them, not as independent parallel-arm groups. The figures are descriptive; they do not by themselves establish a comparative safety difference or provide a complete assessment of safety.
13. What the Result Does, and Does Not, Mean
The primary result estimates the difference in change in pre-bronchodilator FEV1 between MK-1029 plus montelukast and placebo plus montelukast at the end of the 4-week treatment periods. The model-estimated difference was 0.047 liters. The 95% confidence interval, from -0.039 to 0.134 liters, includes zero, and the p-value was 0.282. The registry's primary analysis therefore does not establish superiority of the MK-1029 combination for this endpoint.
That conclusion is narrower than saying the treatments are the same. A result that does not establish superiority is not proof of no effect, and the confidence interval allows for effects in either direction. The record does not report an equivalence or non-inferiority framework, so the finding cannot be interpreted as demonstrating that the treatment conditions are equivalent or acceptably similar.
The result also does not settle whether a difference of a particular size would matter clinically. The registry does not state a threshold for a clinically meaningful change in FEV1. The statistical estimate and its interval describe the evidence and its precision under the reported analysis; they do not determine the importance of a change for an individual or for clinical decisions.
The finding pertains to adults with persistent asthma uncontrolled while maintained on montelukast, under the study's crossover treatment conditions. Both conditions included montelukast, and MK-1029 or placebo was administered during separate treatment periods. The result does not answer questions about other populations, other treatment regimens, outcomes not reported in the available record, or effects beyond the study's treatment periods.
Secondary measures were registered, including symptom scores, short-acting beta agonist use, nocturnal awakenings, peak expiratory flow, and asthma control questionnaire score. Their existence does not alter the primary endpoint result. Without the corresponding outcome results and multiplicity details, they cannot be used to make claims about broader benefit or lack of benefit.
14. Why This Trial Matters Statistically
The study illustrates why a crossover trial's treatment comparison is more than a comparison of two displayed condition means. The same participant can contribute measurements under both treatment conditions, while the order and period of treatment also matter. The registry's LDA model includes treatment, visit, treatment-by-visit interaction, period, and participant as a random effect, reflecting this repeated and period-specific structure.
It also shows the importance of reporting an effect estimate together with uncertainty. The difference in least-squares means is 0.047 liters, but its 95% confidence interval extends from -0.039 to 0.134. The point estimate alone might appear to favor one condition; the interval makes clear that the data are compatible with a range that includes no difference. The p-value of 0.282 adds a test statistic interpretation, but it does not replace the estimate or its interval.
The distinction between a treatment-condition estimate and a treatment contrast is especially useful for readers of crossover studies. The primary question concerns the modeled difference between conditions, not whether each separate condition estimate is distinguishable from zero. The reported model contrast is the relevant result for the superiority hypothesis.
The record also illustrates how transparency about analysis populations and missing data matters. The primary outcome population is defined by treatment receipt and availability of outcome and baseline measurements. The record states the model but does not report further missing-data assumptions or sensitivity analyses. Those details are important to judging how robust an estimate may be when repeated measurements are incomplete.
Finally, the safety counts and the efficacy result answer different questions. The absence of recorded serious adverse events in the listed risk sets is descriptive and cannot establish absence of risk. A careful statistical reading keeps the endpoint, model, uncertainty, analysis population, and safety summaries in their proper scope.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary estimate comes from a crossover study with treatment periods separated by a wash-out period. The registry describes the sequence and wash-out conditions, but further information about possible carryover assessment or how carryover was handled is not reported in the registry record. Period is included in the LDA model, but that alone does not establish how other potential sequence-related issues were evaluated.
The posted outcome analysis uses a defined subset: randomized participants who received at least one dose in a crossover period and had both an outcome measurement and a pre-dose baseline measurement. The record does not give a full account of the number or reasons for participants who were not included in that analysis, or of the handling of missing repeated measurements. The assumptions needed to interpret the model in the presence of missing data are not reported in the registry record.
Although the model terms are specified, other implementation details are not. The registry record does not report the covariance structure, diagnostics, sensitivity analyses, or a fuller statistical analysis plan. These omissions limit independent assessment of the model's fit and the robustness of the estimated difference.
The result is based on the primary endpoint, while the record also lists six secondary outcomes. Multiplicity procedures for interpreting multiple outcomes are not reported in the registry record. The record also does not report a clinically meaningful threshold for FEV1 change, so statistical uncertainty cannot be translated into a judgment about clinical importance.
The study's reported treatment periods lasted 4 weeks. The posted primary comparison therefore describes change at the end of those periods, not longer-term outcomes. The safety information consists of event counts and risk sets, without detailed event descriptions for the other adverse events. These features bound the conclusions that can be drawn from the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: 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.
- Registry record last updated 2019-01-02; status last verified 2018-12.
- Results first posted 2018-11-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT01624974 is a completed randomized, double-blind, placebo-controlled, multicenter crossover study of MK-1029 in adults with persistent asthma uncontrolled on montelukast. Enrollment was 107. Participants received MK-1029 150 mg once daily with montelukast 10 mg once daily and placebo with montelukast in separate 4-week treatment periods, with a 4-week wash-out period between them.
The primary endpoint was change from baseline in pre-bronchodilator FEV1 at Week 4. The LDA model estimated a difference in least-squares means of 0.047 liters for MK-1029 plus montelukast versus placebo plus montelukast, with a 95% confidence interval from -0.039 to 0.134 and p = 0.282. The reported analysis does not establish superiority for the primary endpoint.
The registry also lists secondary symptom, medication-use, peak-flow, and asthma-control outcomes. Serious adverse events and deaths are recorded as 0 in both safety groups. Further details about missing-data procedures, multiplicity, and some model implementation features are not reported in the registry record.