Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01147744 | Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily | PHASE2 | COMPLETED | 700 | — | — | Jun 28, 2010 | Oct 6, 2011 | Oct 2, 2017 | 84 | United States, Bulgaria +4 |
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
| Arm | Type | Description |
|---|---|---|
| GSK2190915 10mg and placebo | EXPERIMENTAL | GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 30mg and placebo | EXPERIMENTAL | GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 100mg QD and placebo | EXPERIMENTAL | GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 300mg QD and placebo | EXPERIMENTAL | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Fluticasone propionate 100mcg and placebo | ACTIVE_COMPARATOR | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening |
| Montelukast 10mg and placebo | ACTIVE_COMPARATOR | Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Placebo Comparator | PLACEBO_COMPARATOR | Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS |
| Name | Type | Description |
|---|---|---|
| Fluticasone Propionate 100mcg via ACCUHALER/DISKUS | DRUG | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS |
| GSK2190915 100mg | DRUG | GSK2190915 100mg (1 x 100mg) once daily in the morning |
| GSK2190915 10mg | DRUG | GSK2190915 10mg (1 x 10mg) once daily in the morning |
| GSK2190915 300mg | DRUG | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning |
| GSK2190915 30mg | DRUG | GSK2190915 30mg (1 x 30mg) once daily in the morning |
| Montelukast 10mg | DRUG | Montelukast 10mg (1 x 10mg capsule) once daily in the evening |
| Placebo GSK2190915 one tablet | DRUG | Placebo tablet, one tablet once daily in the morning |
| Placebo montelukast | DRUG | Placebo capsule once daily in the evening |
| Placebo fluticasone propionate via ACCUHALER/DISKUS | DRUG | Inhaled placebo twice daily via ACCUHALER/DISKUS |
| Placebo GSK2190915 two tablets | DRUG | Placebo tablet, two tablets once daily in the morning |
Inclusion Criteria: * Type of Subject: Outpatient * Age: ≥12 years of age * Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) * Asthma Diagnosis: As defined by NIH * Severity of Disease: FEV1 50-85% predict...