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Fluticasone Propionate · 3 trials · 3 indications
The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.
An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
| Arm | Type | Description |
|---|---|---|
| Fluticasone propionate nasal spray | EXPERIMENTAL | Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning. |
| Placebo nasal spray | PLACEBO_COMPARATOR | Two sprays of placebo per nostril to be administered in morning. |
| fluticasone propionate (FP) | ACTIVE_COMPARATOR | 200 micrograms (mcg); an aqueous suspension of microfine FP |
| fluticasone furoate (FF) | ACTIVE_COMPARATOR | 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF |
| Name | Type | Description |
|---|---|---|
| Fluticasone propionate | DRUG | Nasal spray formulation (200 mcg/day) |
| Placebo | DRUG | Vehicle for Fluticasone propionate aqueous nasal spray |
| fluticasone propionate (FP) | DRUG | 200 micrograms (mcg); an aqueous suspension of microfine FP |
| fluticasone furoate (FF) | DRUG | 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF |
Inclusion Criteria: 1. Participants with good general health (in the opinion of the investigator) with no clinically significant and relevant abnormalities of medical history 2. Participants with diagnosis of seasonal allergic rhinitis 1. A clinical history (written or verbal confirmation) of a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
Fluticasone Propionate is used for respiratory conditions including Allergic Rhinitis, Chronic Obstructive Pulmonary Disease (COPD), Asthma, and Perennial Allergic Rhinitis. It is a small molecule being developed by GSK plc for the Respiratory therapeutic area.
Fluticasone Propionate is developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials for this small molecule in respiratory indications such as allergic rhinitis and COPD.
Fluticasone Propionate is in Phase 3 clinical development. It is an investigational drug, not yet approved, with completed Phase 3 trials in COPD and allergic rhinitis. All nine trials listed are completed, with no active trials currently ongoing.
Fluticasone Propionate has completed trials including NCT01323621 and NCT01323634, both Phase 3 studies comparing it with fluticasone furoate/vilanterol in COPD patients. NCT01817790 assessed its effect on ocular allergy symptoms in allergic rhinitis. NCT00348361 explored biomarkers in allergic rhinitis.
Fluticasone Propionate is a corticosteroid that works by reducing inflammation in the airways. It is used to treat respiratory conditions like asthma, COPD, and allergic rhinitis by decreasing the inflammatory response that causes symptoms.