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Fluticasone Propionate/ salmeterol · 2 trials · 1 indication
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours post-dose on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis of covariance (ANCOVA) was conducted with covariates for country, smoking status, reversibility, and Baseline FEV1.
Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.
| Arm | Type | Description |
|---|---|---|
| Fluticasone Furoate / GW642444 (vilanterol) | EXPERIMENTAL | Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) |
| Fluticasone Propionate / salmeterol | ACTIVE_COMPARATOR | Inhaled Corticosteroid (ICS)/ Long acting Beta Agonist (LABA) |
| Name | Type | Description |
|---|---|---|
| Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg | DRUG | inhalation powder |
| Fluticasone Propionate 250mcg / salmeterol 50mcg | DRUG | inhalation powder |
| Double-dummy placebo | DRUG | inhalation powder |
| Salbutamol as needed | DRUG | inhalation powder |
| Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg | DRUG | inhalation powder |
| Fluticasone Propionate 250mcg/ salmeterol 50mcg | DRUG | inhalation powder |
Inclusion Criteria: * Signed and dated written informed consent * Male or females ≥ 40 years of age * Established clinical history of COPD by ATS/ERS definition * Females are eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum p...
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.