Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FP 100 · 1 trial · 1 indication
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
| Arm | Type | Description |
|---|---|---|
| FP 100mcg BID plus GSK2190915 100mg QD (AM) | EXPERIMENTAL | FP 100mcg BID plus GSK2190915 100mg QD (AM) |
| FP 100mcg BID plus GSK2190915 300mg QD (AM) | EXPERIMENTAL | FP 100mcg BID plus GSK2190915 300mg QD (AM) |
| FP 100mcg BID plus montelukast 10mg QD (PM) | ACTIVE_COMPARATOR | FP 100mcg BID plus montelukast 10mg QD (PM) |
| FP 100mcg BID plus placebo BID | ACTIVE_COMPARATOR | FP 100mcg BID plus placebo BID |
| FP/SAL 100/50mcg BID plus placebo BID | ACTIVE_COMPARATOR | FP/SAL 100/50mcg BID plus placebo BID |
| Name | Type | Description |
|---|---|---|
| FP 100 | DRUG | FP 100mcg BID |
| GSK2190915 100 | DRUG | GSK2190915 100mg QD (AM) |
| GSK2190915 300 | DRUG | GSK2190915 300mg QD (AM) |
| montelukast | DRUG | montelukast 10mg QD (PM) |
| placebo | DRUG | placebo BID |
| FP/SAL 100/50 | DRUG | FP/SAL 100/50mcg BID |
Inclusion Criteria: * Age: 12 years of age or older * Non-, former or current smokers with a documented smoking history of ≤ 10 pack years * Asthma diagnosis as defined by the National Institutes of Health * Best FEV1 of 50% to \<80% of the predicted normal value * Post-albuterol FEV1/FVC ratio of ...
FP 100 is an investigational small molecule being developed for the treatment of asthma. It is intended for use in patients 12 years of age and older. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
FP 100 is a small molecule developed by GSK plc. The specific molecular target of FP 100 has not been disclosed in available information. The drug is being studied for its potential to improve asthma control when added to low-dose inhaled corticosteroid therapy.
FP 100 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and efficacy of FP 100 in patients with asthma.
FP 100 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of asthma in patients aged 12 years and older.
FP 100 has been studied in one completed Phase 2 clinical trial, identified as NCT01156792. This randomized, double-blind, active-controlled study evaluated the safety and efficacy of adding FP 100 to low-dose inhaled corticosteroid treatment in asthma patients aged 12 years and older. The trial enrolled 162 participants in the United States.
FP 100 is also known as GSK2190915. In clinical trial NCT01156792, the drug is referred to as GSK2190915. This compound is being developed by GSK plc for the treatment of asthma and is currently in Phase 2 clinical development.