Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW815SF HFA MDI · 1 trial · 1 indication
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \[Weeks 1-4/Weeks 7-10\]).
| Arm | Type | Description |
|---|---|---|
| SLM+FP First | ACTIVE_COMPARATOR | SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period). |
| SFC First | ACTIVE_COMPARATOR | SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period). |
| SFC | EXPERIMENTAL | SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period). |
| Name | Type | Description |
|---|---|---|
| GW815SF HFA MDI | DRUG | salmeterol and fluticasone propionate combination |
| salmeterol and fluticasone propionate | DRUG | salmeterol + fluticasone propionate |
Inclusion criteria: * Inclusion Criteria for Entry in Run-in Period A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study: * Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing po...
GW815SF HFA MDI is an investigational small molecule being developed for the treatment of bronchial asthma. It is administered as a metered dose inhaler with hydrofluoroalkane propellant. The drug is currently in Phase 3 clinical development for this respiratory condition.
GW815SF HFA MDI is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with bronchial asthma.
GW815SF HFA MDI is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being studied for the treatment of bronchial asthma.
GW815SF HFA MDI has one completed Phase 3 clinical trial registered under NCT00448435. This trial, titled "Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma," enrolled 51 participants in Japan. The study included patients aged 5 years and older with bronchial asthma.
GW815SF HFA MDI is a small molecule delivered via a metered dose inhaler. The specific molecular target of the drug has not been disclosed in available information. It is being studied for its ability to manage symptoms of bronchial asthma in pediatric patients.