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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01499446 | A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma. | PHASE2 | COMPLETED | 669 | — | — | Sep 1, 2003 | Mar 1, 2004 | Sep 15, 2016 | 64 | Brazil, Bulgaria +11 |
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
| Arm | Type | Description |
|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | EXPERIMENTAL | - |
| GW685698X (fluticasone furoate) 100mcg Evening | EXPERIMENTAL | - |
| GW685698X (fluticasone furoate) 250mcg Evening | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GW685698X (fluticasone furoate) 100mcg Morning | DRUG | GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days |
| GW685698X (fluticasone furoate) 100mcg Evening | DRUG | GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days |
| GW685698X (fluticasone furoate) 250mcg Evening | DRUG | GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days |
| Placebo | DRUG | Placebo inhaled twice daily (morning and evening) for 28 days |
Inclusion Criteria: * Outpatients aged between 16- 65 years. * Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods * Documented clinical history of persistent asthma first...