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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 being developed for the treatment of bronchial asthma. It is an inhaled combination product studied in pediatric patients aged 5 years and older. The development program is in Phase 3 and the single listed trial has been completed.
GW815SF Salmeterol/Fluticasone propionate is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this inhaled asthma therapy.
GW815SF Salmeterol/Fluticasone propionate is in Phase 3 development. The program includes one completed Phase 3 trial, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA.
GW815SF Salmeterol/Fluticasone propionate has been studied in one Phase 3 trial, NCT00449046. The trial was a 24-week long-term study in pediatric patients with bronchial asthma, conducted in Japan, and it has been completed. It enrolled 40 patients aged 5 years and older.