Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FSC · 2 trials · 2 indications
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | Placebo administered BID by multi-dose inhaler followed by FSC (250/50 mcg) administered BID by capsule-based inhaler. |
| Regimen B | EXPERIMENTAL | FSC (250/50 mcg) administered BID by multi-dose inhaler followed by placebo administered BID by capsule-based inhaler. |
| Sequence 1 | EXPERIMENTAL | Subjects in this Arm will receive Regimen A followed by Regimen B. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler |
| Sequence 2 | EXPERIMENTAL | Subjects in this Arm will receive Regimen B followed by Regimen A. Regimen B: FSC (250/50 mcg) administered BID by Multi-Dose Inhaler followed by Placebo administered BID by Capsule-Based Inhaler. Regimen A: Placebo administered BID by Multi-Dose Inhaler followed by FSC (250/50 mcg) administered BID by Capsule-Based Inhaler |
| Name | Type | Description |
|---|---|---|
| FSC | DRUG | Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods |
| Placebo | DRUG | Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods |
Inclusion Criteria: * Male or female \>=40 and \<=80 years of age at the time of signing the informed consent. * A female subject is eligible to participate if she is of: Non-childbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal...
FSC is a combination dry powder of fluticasone propionate and salmeterol being developed for asthma and chronic obstructive pulmonary disease (COPD). It is administered twice daily through an inhaler. In clinical trials, it has been studied in adults and adolescents with asthma and in adults with COPD.
FSC combines fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta-agonist. The fluticasone component reduces airway inflammation, while the salmeterol component relaxes airway muscles to improve breathing. This dual mechanism addresses both inflammation and bronchoconstriction in respiratory diseases.
FSC is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the efficacy, safety, and tolerability of FSC in patients with asthma and COPD.
FSC is in Phase 3 clinical development. Two Phase 3 trials have been completed: one in asthma with 124 participants and one in COPD with 665 participants. Both trials were randomized, double-blind, and controlled, but FSC is still investigational and not yet approved by regulatory authorities.
FSC has been studied in two completed Phase 3 trials. NCT01978119 evaluated FSC 250/50 mcg twice daily in 124 adults and adolescents with asthma in Russia and Ukraine. NCT01978145 evaluated the same dose in 665 adults with COPD in Argentina, Mexico, Russia, and Ukraine.
Yes, FSC is the acronym for the fixed-dose combination of fluticasone propionate and salmeterol. The drug is referred to as FSC in clinical trial documentation, and the individual components are fluticasone propionate, a corticosteroid, and salmeterol, a long-acting beta-agonist.