Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2269557 DPI · 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. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose).
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose). The analysis was performed on the PP Population which comprised of all participants in the ITT Population not identified as major protocol violators.
| Arm | Type | Description |
|---|---|---|
| GSK2269557 and Placebo | EXPERIMENTAL | Each subject will complete two treatment periods: GSK2269557 1000 mcg in one treatment period, and matching placebo in the other treatment period. Each treatment will be administered once daily for 28 days (+/- 2 days) via the DISKUS DPI. The treatment periods will be separated by a washout of at least 4 weeks. |
| Name | Type | Description |
|---|---|---|
| GSK2269557 DPI | DRUG | GSK2269557 will be supplied as a lactose blend in a DISKUS DPI with a unit dose strength of 500 mcg. 2 inhalations will be taken every morning before breakfast. |
| Placebo DPI | DRUG | Placebo will be lactose in a DISKUS DPI. 2 inhalations will be taken every morning before breakfast. |
Inclusion Criteria: * Between 18 and 70 years of age inclusive, at the time of signing the informed consent. * Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with an intermittent short acting beta 2 agonist (SA...
GSK2269557 DPI is an investigational small molecule being developed for the treatment of chronic obstructive pulmonary disease. It is administered as a dry powder inhaler. The drug is currently in clinical development and has not been approved for any use.
The specific molecular target of GSK2269557 DPI has not been disclosed in available information. It is a small molecule developed by GSK plc for respiratory conditions, but its mechanism of action is not publicly detailed.
GSK2269557 DPI is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's efficacy and safety.
GSK2269557 DPI is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
GSK2269557 DPI has one completed clinical trial registered under NCT02567708. This Phase 2 study investigated the efficacy, safety, and tolerability of repeat doses of inhaled GSK2269557 in adults with persistent, uncontrolled asthma. The trial enrolled 50 participants in Germany.
No alternative names for GSK2269557 DPI have been disclosed. The drug is identified solely by its development code GSK2269557 and is not known to be marketed under any other name.