Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03162055 | Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 1,119 | — | — | May 25, 2017 | May 4, 2018 | May 22, 2019 | 107 | United States, Bulgaria +5 |
To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.
To assess the effects of GFF relative to UV on lung function in PP analysis set population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
To assess the effects of GFF relative to UV on lung function in FAS population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | glycopyrronium/formoterol fumarate 7.2/4.8 μg per actuation, twice daily |
| Active comparator | ACTIVE_COMPARATOR | umeclidinium/vilanterol 62.5/ 25μg per inhalation, once daily |
| Name | Type | Description |
|---|---|---|
| Glycopyrronium/Formoterol Fumarate | DRUG | Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation |
| umeclidinium/vilanterol | DRUG | Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation |
Inclusion criteria: * Age 40-95 years at screening * Current or former smoker with a history of at least 10 pack-years of cigarette smoking * Current clinical diagnosis of COPD, with COPD symptoms \> 1 year prior to screening, as defined by GOLD criteria or other current guidelines * COPD Severity ...