Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FF/LEV · 2 trials · 1 indication
The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale \[0=none, 1=mild, 2=moderate, 3=severe\]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.
Concentrations of FF and LEV will be determined in plasma samples
From the plasma concentration-time data, area under the plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of FF and LEV were determined
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Each Subject will be assigned to a sequence of three treatments (e.g ABC, BCD, ACD): A=Two, 50 microliter (mcqL) sprays per nostril of FF, total dose 100 microgram (mcg); B=Two, 50 mcqL sprays per nostril of levocabastine, total dose 200 mcg; C=Two, 50 mcql sprays per nostril of FF/levocabastine FDC, total daily dose 100 mcg FF and 200 mcg levocabastine; D=Two, 50 mcql sprays per nostril of placebo. There will be a wash out period of 14-28 days between two treatment periods |
| Name | Type | Description |
|---|---|---|
| FF/levocabastine | DRUG | FF/levocabastine (25mcg/50 mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. |
| FF | DRUG | FF (25mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. |
| levocabastine | DRUG | levocabastine (50mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. |
| Placebo | DRUG | Placebo will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. |
| FF/LEV FDC | DRUG | Intranasal aqueous microsuspension containing 25.0 microgram (µg) of FF and 50 µg of LEV as a fixed dose combination. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state |
| LEV | DRUG | Intranasal aqueous microsuspension containing 50 µg of LEV. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state |
Inclusion Criteria: * Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities. * Subjects have a TNSS score of \>=6 during the screening allergen challenge chamber. * ...
FF, also known as FF/UMEC/VI, is an investigational small molecule being developed for respiratory conditions including allergic rhinitis (perennial and seasonal), asthma, and chronic obstructive pulmonary disease (COPD). It is currently in Phase 3 clinical development.
FF is a combination product containing fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI). Fluticasone furoate is a corticosteroid, umeclidinium is an antimuscarinic, and vilanterol is a beta-2 agonist. Together they target inflammation and bronchoconstriction in respiratory diseases.
FF is developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is being studied for respiratory indications including asthma, COPD, and allergic rhinitis.
FF is currently in Phase 3 clinical development. It has completed 13 trials and has 1 active trial, with a total of 14 clinical trials conducted involving 11,862 participants.
FF has been studied in multiple trials including NCT01266980, NCT01894386, NCT02164539, and NCT02837380. These trials have evaluated the drug in healthy subjects and patients with COPD, across various countries including the United States, China, and European nations.
Yes, FF is also known as FF/UMEC/VI. This name reflects its three active components: fluticasone furoate (FF), umeclidinium (UMEC), and vilanterol (VI). The drug is being developed for respiratory conditions.