| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02720081 | Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015) | PHASE2 | COMPLETED | 142 | — | — | May 11, 2016 | Sep 6, 2017 | Sep 27, 2018 | - | — |
| 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) | PHASE2 | COMPLETED | 107 | — | — | Aug 9, 2012 | May 5, 2014 | Jan 2, 2019 | - | — |
| NCT01370317 | Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma | PHASE1 | COMPLETED | 27 | — | — | Jun 1, 2011 | Dec 27, 2011 | Jan 25, 2019 | 5 | United States, Australia +2 |
| NCT01343407 | A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003) | PHASE1 | COMPLETED | 16 | — | — | Apr 19, 2011 | Jan 9, 2012 | Mar 1, 2019 | - | — |
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.
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.
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 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.
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.
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L\*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.
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 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.
| Arm | Type | Description |
|---|---|---|
| MK-1029 150 mg + Montelukast 10 mg | EXPERIMENTAL | Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 150 mg + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. |
| MK-1029 Placebo + Montelukast 10 mg | PLACEBO_COMPARATOR | Participants receive single-blind MK-1029 Matching-image Placebo + open-label Montelukast 10 mg for a 2 to 4 week run-in period while discontinuing or tapering off asthma controller medications. Participants receive double-blind MK-1029 Matching-image Placebo + Montelukast 10 mg for 6 weeks in the treatment period. Participants can use rescue medication during both periods as needed. |
| 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. |
| 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. |
| MK-1029 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| MK-1029 60 mg | EXPERIMENTAL | Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design |
| MK-1029 500 mg | EXPERIMENTAL | Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design |
| Name | Type | Description |
|---|---|---|
| MK-1029 150 mg | DRUG | 150 mg tablet administered orally, once a day (QD), at bedtime |
| MK-1029 Matching-image Placebo | DRUG | Matching-image placebo tablet administered orally, QD, at bedtime |
| Montelukast 10 mg | DRUG | 10 mg tablet administered orally, QD, at bedtime |
| Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation | DRUG | 1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication |
| MK-1029 | DRUG | MK-1029 150 mg tablets taken QD |
| Placebo | DRUG | Placebo tablets (matching the MK-1029 150 mg tablets) QD |
| Montelukast (ML) | DRUG | ML 10 mg tablets QD |
| Placebo for MK-1029 | DRUG | Five (5) X 100 mg capsules, orally, once daily for 28 days |
| MK-1029 10 mg | DRUG | Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design |
| MK-1029 100 mg | DRUG | Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design |
| Placebo for MK-1029 10 mg | DRUG | Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design." |
| Placebo for MK-1029 100 mg | DRUG | Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design |
Inclusion Criteria: * Symptoms of persistent asthma for at least one year * History of asthma treatments including "as-needed" inhaled short-acting beta-agonists (albuterol/salbutamol); stable doses of inhaled corticosteroids (ICS), combination ICS/long-acting (inhaled) Beta2-adrenergic agonist (LA...