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GW815SF Salmeterol/Fluticasone propionate · 1 trial · 1 indication
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
| Name | Type | Description |
|---|---|---|
| GW815SF Salmeterol/Fluticasone propionate(HFA MDI) | DRUG | - |
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 Salmeterol/Fluticasone propionate is used for the treatment of bronchial asthma. It is a combination product being developed by GSK plc for this respiratory condition. The drug is currently in Phase 3 clinical development and is intended for pediatric patients with bronchial asthma.
GW815SF Salmeterol/Fluticasone propionate is a combination of two active ingredients: salmeterol, a long-acting beta-agonist, and fluticasone propionate, an inhaled corticosteroid. These components work together to provide bronchodilation and reduce airway inflammation in patients with bronchial asthma.
GW815SF Salmeterol/Fluticasone propionate 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 this combination therapy for the treatment of bronchial asthma.
GW815SF Salmeterol/Fluticasone propionate is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. A Phase 3 clinical trial has been completed to assess its safety and efficacy in pediatric patients with bronchial asthma.
GW815SF Salmeterol/Fluticasone propionate has one completed clinical trial, identified as NCT00449046. This was a Phase 3, long-term (24-week) study conducted in Japan, enrolling 40 pediatric patients aged 5 years and older with bronchial asthma. The trial was uncontrolled and not randomized or double-blinded.
GW815SF Salmeterol/Fluticasone propionate is a specific formulation of the combination of salmeterol and fluticasone propionate, delivered via a hydrofluoroalkane (HFA) metered-dose inhaler. It is being studied for pediatric use in Japan and is distinct from other marketed combination products of these two drugs.