Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Triple FF/UMEC/VI · 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. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 52 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. Extension Population: all participants in the ITT Population who were enrolled into the subset of participants with extension to 52 weeks.
The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 24 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions
The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 52 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions.
| Arm | Type | Description |
|---|---|---|
| FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) | EXPERIMENTAL | Each subject will inhale once from their ELLIPTA DPI and once from the reservoir inhaler in the morning and once from the reservoir inhaler in the evening, for 24 weeks (or 52 weeks for subjects participating in the extension part of the study). Subjects will receive FF/UMEC/VI (100mcg/62.5mcg/25mcg) via the ELLIPTA DPI and placebo via reservoir inhaler. |
| Budesonide/formoterol (400 mcg/12 mcg) | EXPERIMENTAL | Each subject will inhale once from their ELLIPTA DPI and once from the reservoir inhaler in the morning and once from the reservoir inhaler in the evening, for 24 weeks (or 52 weeks for subjects participating in the extension part of the study). Subjects will receive Budesonide/formoterol (400mcg/12mcg) via reservoir inhaler and placebo via the ELLIPTA DPI. |
| Name | Type | Description |
|---|---|---|
| Triple FF/UMEC/VI | DRUG | The combination will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip). It will have 100 mcg of FF (blended with lactose) per blister, 62.5 mcg of UMEC (blended with lactose and magnesium stearate) per blister and 25 mcg of VI (blended with lactose) per blister. |
| Placebo to match FF/UMEC/VI | DRUG | The placebo (Lactose) will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip). |
| Budesonide/Formoterol | DRUG | The combination (400 mcg Budesonide/12 mcg Formoterol) will be provided as inhalation via TURBOHALER with 60 doses. |
| Placebo to match Budesonide/Formoterol combination | DRUG | The placebo (Lactose) will be provided as inhalation via TURBOHALER with 60 doses. |
| Albuterol/salbutamol | DRUG | Albuterol/salbutamol will be available as an inhalation via metered-dose inhaler (MDI) with a spacer and will be issued for reversibility testing at Visit 1 Albuterol/salbutamol MDI or NEBULES™ for as needed (prn) use throughout the study will be provided starting at Visit 1. |
Inclusion Criteria: * Informed Consent: A signed and dated written informed consent prior to study participation. * Type of subject: Outpatient. * Age: Subjects 40 years of age or older at Screening (Visit 1). * Gender: Male or female subjects. A female is eligible to enter and participate in the s...
Triple FF/UMEC/VI is an investigational fixed-dose combination of fluticasone furoate, umeclidinium, and vilanterol trifenatate being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is a small molecule therapy in Phase 3 clinical development, evaluated in a completed trial with 1,811 participants.
Triple FF/UMEC/VI combines three active components: fluticasone furoate, an inhaled corticosteroid; umeclidinium, a long-acting muscarinic antagonist; and vilanterol trifenatate, a long-acting beta2-adrenergic agonist. Together they target inflammation, bronchoconstriction, and airway relaxation in COPD.
Triple FF/UMEC/VI is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The drug is currently in Phase 3 clinical development for chronic obstructive pulmonary disease.
Triple FF/UMEC/VI is in Phase 3 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 3 trial in chronic obstructive pulmonary disease. The trial enrolled 1,811 participants and was randomized, double-blind, and controlled.
Triple FF/UMEC/VI has one completed Phase 3 trial, NCT02345161, which compared the fixed-dose triple combination of fluticasone furoate, umeclidinium, and vilanterol trifenatate with budesonide/formoterol in subjects with COPD. The trial enrolled 1,811 participants across multiple countries.
Yes, Triple FF/UMEC/VI is the same as the fixed-dose triple combination of fluticasone furoate, umeclidinium, and vilanterol trifenatate. The abbreviation FF/UMEC/VI refers to these three active ingredients combined in a single inhaler for COPD treatment.