Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
400 microgrammes GSK961081 · 1 trial · 1 indication
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...
GSK961081 is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease (COPD). It is currently in Phase 2 clinical development and has been studied in a completed clinical trial involving 45 patients with COPD.
The specific molecular target of GSK961081 has not been disclosed. It is being studied for its interaction with inhaled beta-agonist and anti-muscarinic drugs, which are commonly used in COPD treatment, but its precise mechanism of action is not publicly detailed.
GSK961081 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol TBPH. The company is focused on respiratory therapies and is advancing GSK961081 through clinical development for COPD.
GSK961081 is in Phase 2 clinical development. It has completed one Phase 2 trial, and there are no active trials currently listed for this drug. It remains an investigational agent and has not been approved by regulatory authorities.
GSK961081 has been studied in one completed Phase 2 clinical trial with the identifier NCT00674817. This trial investigated the interaction of GSK961081 with inhaled beta-agonist and anti-muscarinic drugs in 45 patients with chronic obstructive pulmonary disease.
Yes, GSK961081 is also referred to as 400 microgrammes GSK961081, which specifies the dosage strength used in clinical studies. The drug is being developed by Theravance Biopharma for the treatment of chronic obstructive pulmonary disease.