Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as UMEC
UMEC/VI · 6 trials · 2 indications
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the 2 assessments made 30 and 5 minutes (min) pre-dose (PD) on Day 1. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after dosing on Day 84 (at Week 12 + 1 day). Analysis was performed using mixed model repeated measures (RM) with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1), center group, day, day by BL interaction and day by trt interaction, where day was nominal.
The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
FEV1 is a measure of lung function and is 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 post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.
FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.
For both single dose and repeat dose
For both single dose and repeat dose
For both single dose and repeat dose
For both single dose and repeat dose
For both single dose and repeat dose
For both single dose and repeat dose
For single dose
For single dose
For both single dose and repeat dose
For repeat dose
For repeat dose
For repeat dose
For repeat dose
For repeat dose
The PK parameters and plasma concentrations: area under the concentration time-curve (AUC) from time zero to infinity (AUC(0-inf)) or AUC from time zero to last time of quantifiable concentration AUC(0-t') and maximum observed plasma concentration (Cmax) will be derived for each treatment group following single inhaled doses (four inhalations) of FF/UMEC/VI, UMEC/VI and FF/VI using the following treatment ratios: FF:FF/UMEC/VI versus FF/VI, UMEC:FF/UMEC/VI versus UMEC/VI, VI: FF/UMEC/VI versus UMEC/VI and VI: FF/UMEC/VI versus FF/VI.
| Arm | Type | Description |
|---|---|---|
| UMEC/VI arm | EXPERIMENTAL | Participants will be instructed to self-administer one dose each morning of UMEC/VI Inhalation Powder 62.5/25 mcg once daily via ELLIPTA DPI, placebo once daily via HANDIHALER inhaler and placebo once daily via BREEZHALER inhaler |
| Tiotropium + Indacaterol arm | PLACEBO_COMPARATOR | Participants will be instructed to self-administer one dose each morning of Tiotropium bromide 18 mcg once daily via HANDIHALER inhaler, Indacaterol 150 mcg once daily via BREEZHALER inhaler and placebo once daily via ELLIPTA DPI |
| Umeclidinium/Vilanterol 62.5/25 mcg once daily | EXPERIMENTAL | The subjects will receive UMEC/VI 62.5/25 mcg, administered as one inhalation once-daily in the morning via a dry powder inhaler (DPI) |
| Placebo once daily | PLACEBO_COMPARATOR | The subjects will receive placebo, administered as one inhalation once-daily in the morning via a DPI |
| UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm | EXPERIMENTAL | Subjects will receive one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning via the NDPI and one inhalation of placebo in the morning and evening via ACCUHALER/DISKUS inhaler |
| FSC via ACCUHALER/DISKUS + placebo NDPI arm | ACTIVE_COMPARATOR | Subjects will receive one inhalation of FSC 250/50 mcg in the morning and evening via ACCUHALER/DISKUS inhaler and one inhalation of placebo administered once-daily in the morning via NDPI |
| Placebo | PLACEBO_COMPARATOR | Subjects will be administered placebo once daily via the ELLIPTA® dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. ELLIPTA is a registered trademark of the GSK group of companies. |
| UMEC 62.5 mcg | EXPERIMENTAL | Subjects will be administered UMEC 62.5 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. |
| UMEC 31.25 mcg | EXPERIMENTAL | Subjects will be administered UMEC 31.25 mcg once daily via the ELLIPTA dry powder inhaler (DPI) for 24 weeks. Subjects will also receive FF 100 mcg once daily, in the morning for 24 weeks. |
| UMEC/VI 125/25 mcg | EXPERIMENTAL | Combination in high dose |
| UMEC/VI 62.5/25 mcg | EXPERIMENTAL | Combination in low dose |
| UMEC 125 mcg | EXPERIMENTAL | LAMA mono in high dose |
| VI 25 mcg | EXPERIMENTAL | LABA mono |
| UMEC/VI+FF | EXPERIMENTAL | UMEC (500 µg)/VI(100 µg) (blended together) and FF (400 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. |
| UMEC+VI | EXPERIMENTAL | UMEC (500 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. |
| FF+VI | EXPERIMENTAL | FF (400 µg) and VI (100 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. |
| FF+UMEC | EXPERIMENTAL | FF (400 µg) and UMEC (500 µg) will be administered as single dose (4 inhalations); as dry powder in NDPI device once in 7 days in one of the 4 Treatment Periods of the study. |
| Name | Type | Description |
|---|---|---|
| UMEC/VI | DRUG | ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains Umeclidinium bromide (unit dose strengths 62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate 0.6% weight/weight (w/w) of total drug product and second strip contains Vilanterol (unit dose strengths 25 mcg per blister) blended with lactose monohydrate and magnesium stearate 1.0% w/w of total drug product |
| UMEC/VI matching placebo | DRUG | ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains lactose monohydrate and magnesium stearate 0.6% w/w of total drug product and second strip contains lactose monohydrate and magnesium stearate 1.0% w/w of total drug product |
| Tiotropium | DRUG | Tiotropium (as bromide monohydrate) inhalation capsules 18 mcg per dose will be supplied along with HANDIHALER inhalers manufactured by Boehringer Ingelheim |
| Tiotropium matching placebo | DRUG | Tiotropium matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with HANDIHALER inhalers |
| Indacaterol | DRUG | Indacaterol inhalation capsules 150 mcg per dose will be supplied by GSK along with BREEZHALER inhalers manufactured by Novartis |
| Indacaterol matching placebo | DRUG | Indacaterol matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with BREEZHALER inhalers manufactured by Novartis |
| Albuterol/salbutamol Metered Dose Inhaler (MDI) | DRUG | Albuterol/salbutamol MDI or nebules for as needed use will be issued throughout the study. Albuterol/salbutamol will be sourced from local commercial stock. If not available locally, GSK will source centrally |
| Placebo | DRUG | Dry white powder delivered via DPI (2 strips with 30 blisters each, both containing lactose with magnesium stearate), administered as one inhalation of placebo |
| UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI | DRUG | The drug is administered via NDPI as one inhalation once daily in the morning. NDPI has two strips, each containing 30 blisters of medication. The first strip has UMEC blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 62.5 mcg per blister and the second strip has VI blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 25 mcg per blister. |
| FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS | DRUG | The drug is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains a single strip with 60 blisters of medication. The strip has 250 mcg of fluticasone propionate and 50 mcg of salmeterol per blister in the form of dry white powder. |
| Placebo DISKUS | DRUG | Placebo is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains 1 strip with 60 blisters of placebo in the form of dry white powder. |
| Placebo NDPI | DRUG | Placebo is administered via NDPI as one inhalation once daily in the morning. The inhaler contains 2 strips with 30 blisters of placebo per strip in the form of dry white powder. |
| UMEC | DRUG | UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate. |
| Fluticasone Furoate | DRUG | FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate. |
| Albuterol/salbutamol | DRUG | Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study. |
| UMEC/VI 125/25 mcg | DRUG | Combination in high dose |
| UMEC/VI 62.5/25 mcg | DRUG | Combination in low dose |
| UMEC 125 mcg | DRUG | LAMA mono in high dose |
| UMEC 62.5 mcg | DRUG | LAMA mono in low dose |
| VI 25 mcg | DRUG | LABA mono |
| UMEC /VI | DRUG | Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA). UMEC/VI (blended together) will be available as dry powder in the dose of 125 µg /25 µg per inhalation. |
| VI | DRUG | Vilanterol is a long-acting beta2 agonist (LABA). VI will be available as dry powder in the dose of 25 µg per inhalation. |
| FF | DRUG | Fluticasone Furoate is a novel inhaled corticosteroid (ICS). FF will be available as dry powder in the dose of 100 µg per inhalation. |
Inclusion Criteria: * Type of subject: Outpatient * Informed Consent: A signed and dated written informed consent prior to study participation. * Participants 40 years of age or older at Visit 1. * Gender: Male or female participants. A female is eligible to enter and participate in the study if sh...
UMEC/VI is an investigational inhaled fixed-dose combination studied for asthma and chronic obstructive pulmonary disease (COPD). Clinical trials have evaluated it in adults with COPD and in adults with asthma. It combines umeclidinium and vilanterol and is being developed by GSK plc.
UMEC/VI is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials of the combination, including Phase 1, Phase 2 and Phase 3 studies in COPD and a Phase 2b study in asthma.
UMEC/VI has been studied across Phase 1, Phase 2 and Phase 3 clinical trials, with five completed trials and no active trials. It is an investigational product and is not described as approved. The completed studies enrolled a total of 2,229 participants.
Completed trials include NCT03012061, a Phase 2b study of umeclidinium versus placebo in asthma; NCT02257385, a Phase 3 comparison with indacaterol plus tiotropium in COPD; NCT02152605, a Phase 3b COPD efficacy study; and NCT01899638, a Phase 1 pharmacokinetic study in healthy Chinese participants.
UMEC/VI is a fixed-dose combination of umeclidinium and vilanterol, while UMEC refers to umeclidinium alone. UMEC/VI is also written as UMEC /VI, UMEC 500 mcg, UMEC/VI 125/25 mcg, UMEC/VI 125, and UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI.
UMEC/VI combines umeclidinium, a long-acting muscarinic antagonist, with vilanterol, a long-acting beta2-adrenergic agonist. These two components target muscarinic receptors and beta2-adrenergic receptors respectively to produce bronchodilation in the airways.