Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP/SAL 250 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fluticasone propionate/salmeterol combination | EXPERIMENTAL | study drug |
| Fluticasone propionate | EXPERIMENTAL | study drug |
| Placebo | EXPERIMENTAL | placebo |
| FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) | EXPERIMENTAL | FP/SAL 250/50mcg BID plus GSK2190915 300mg QD (AM) |
| FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) | ACTIVE_COMPARATOR | FP/SAL 250/50mcg BID plus montelukast 10mg QD (PM) |
| FP/SAL 250/50mcg BID plus placebo BID | PLACEBO_COMPARATOR | P/SAL 250/50mcg BID plus placebo BID |
| Name | Type | Description |
|---|---|---|
| FP 100mcg | DRUG | Once-daily dosing |
| FSC 100/50mcg | DRUG | Once-daily dosing |
| Placebo | DRUG | Once-daily dosing |
| FP/SAL 250/50mcg BID | DRUG | FP/SAL 250/50mcg BID |
| GSK2190915 200mg QD (AM) | DRUG | GSK2190915 200mg QD (AM) |
| GSK2190915 100mg QD (AM) | DRUG | GSK2190915 100mg QD (AM) |
| Montelukast 10mg QD (PM) | DRUG | Montelukast 10mg QD (PM) |
| Placebo tablets (2) (AM) | DRUG | Placebo tablets (2) (AM) |
| Placebo capsule (PM) | DRUG | Placebo capsule (PM) |
Inclusion Criteria: * Out-patients * Asthma diagnosis * Reversibility * Short-acting beta-agonist or asthma controlled medication use Exclusion Criteria: * Life-threatening asthma * Specified asthma medications * Chickenpox * Drug allergy * Respiratory infections * Tobacco use * Clinical laborato...
FP/SAL 250 is an investigational small molecule being developed for the treatment of asthma. It is a combination product studied in patients with asthma, including a pediatric population aged 4 years and older. The drug is in clinical development and has not been approved by regulatory authorities.
FP/SAL 250 is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with asthma.
FP/SAL 250 is in Phase 3 clinical development for asthma. It has completed two clinical trials, including a Phase 3 study and a Phase 2 study. The drug remains investigational and is not yet approved for commercial use.
FP/SAL 250 has been studied in two completed clinical trials. NCT00920959 was a Phase 3 pediatric study of once-daily Advair in asthma, enrolling 908 participants. NCT01248975 was a Phase 2 study adding GSK2190915 to mid-dose inhaled corticosteroid/long-acting beta agonist combination treatment for asthma, enrolling 145 female participants.
FP/SAL 250 is a combination product that includes fluticasone propionate and salmeterol, the same active ingredients as Advair. The Phase 3 trial NCT00920959 was titled 'Advair Pediatric Once-Daily,' indicating the drug is related to or identical to Advair in composition.