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 inhaled small molecule developed by GSK plc. It is a PIK3CD inhibitor that has been studied in a Phase 2 clinical trial in adults with persistent, uncontrolled asthma. The drug is delivered as a dry powder inhalation and is not approved for any indication.
GSK2269557 DPI has been studied for the treatment of persistent, uncontrolled asthma in adults. It is an investigational therapy and has not been approved for any use. The only completed trial enrolled 50 adults with this condition.
GSK2269557 DPI targets PIK3CD, also known as phosphoinositide 3-kinase delta. It acts as an inhibitor of this target. By inhibiting PIK3CD, the drug is designed to modulate inflammatory pathways relevant to respiratory disease.
GSK2269557 DPI is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this inhaled PIK3CD inhibitor.
GSK2269557 DPI is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.
GSK2269557 DPI has been evaluated in one completed Phase 2 trial, NCT02567708, titled "A Study to Investigate the Efficacy, Safety, and Tolerability of Repeat Doses of Inhaled GSK2269557 in Adults With Persistent, Uncontrolled Asthma." The trial enrolled 50 participants in Germany and was randomized and double-blind.