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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00674817 | An Investigation Of The Interaction Of GSK961081 With Inhaled Beta-Agonist And Anti-Muscarinic Drugs. | PHASE2 | COMPLETED | 45 | — | — | Apr 1, 2008 | Oct 19, 2008 | Oct 20, 2021 | 4 | New Zealand, Thailand +1 |
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second as measured by spirometry. Adjusted mean has been presented as least square (LS) mean.
| Arm | Type | Description |
|---|---|---|
| 400 microgrammes GSK961081 and salbutamol | EXPERIMENTAL | 400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing. |
| 1200 microgrammes GSK961081 and salbutamol | EXPERIMENTAL | 1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (3x 200 microgrammes at 20 min intervals, administered via spacer) of salbutamol at 1h, 12h and 24h of dosing. |
| 400 microgrammes GSK961081 and ipratropium bromide | EXPERIMENTAL | 400 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing. |
| 1200 microgrammes of GSK961081 and ipratropium bromide | EXPERIMENTAL | 1200 microgrammes of GSK961081 single-dose (via DISKUS MDPI) followed by cumulative doses (20 microgrammes, 20 microgrammes and 40 microgrammes at 20 min intervals, administered via spacer) of ipratropium bromide at 1h, 12h and 24h of dosing. |
| 400 microgrammes of GSK961081 and placebo | PLACEBO_COMPARATOR | 400 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing. |
| 1200 microgrammes of GSK961081 and placebo | PLACEBO_COMPARATOR | 1200 microgrammes of GSK961081 single-dose (via DISKUS Metered Dry Powder Inhaler/ MDPI) followed by cumulative doses (3 doses at 20 min intervals, administered via spacer) of placebo at 1h, 12h and 24h of dosing. |
| Name | Type | Description |
|---|---|---|
| 400 microgrammes GSK961081 | DRUG | Inhaled GSK961081 administered via Dry Powder Inhaler. |
| 1200 microgrammes GSK961081 | DRUG | Inhaled GSK961081 adminisntered via dry powder inhaler. |
Inclusion Criteria: * Subject is male or female (of non-child bearing potential) ≥ 40 years of age and ≤ 75 years of age. * Non- child bearing potential is defined as physiologically incapable of becoming pregnant, including females who are post-menopausal (more than 2 years without menses with app...