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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03836677 | A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD | PHASE3 | COMPLETED | 23 | — | — | Feb 26, 2019 | Nov 11, 2019 | Feb 11, 2021 | 4 | Belgium, Netherlands |
Specific image-based airway volume (SiVaw) measured in mL/L. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
Specific image-based airway resistance (siRaw) measured in kPa∙s. Average across lobes, adjusted for lobe volume. Reported as ratio to baseline.
| Arm | Type | Description |
|---|---|---|
| BGF-GFF | EXPERIMENTAL | Subject first treated with Budesonide/Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Glycopyrronium/Formoterol Fumarate |
| GFF-BGF | EXPERIMENTAL | Subject first treated with Glycopyrronium/Formoterol Fumarate followed by a washout period then treated with Budesonide/Glycopyrronium/Formoterol Fumarate |
| Name | Type | Description |
|---|---|---|
| BGF | COMBINATION_PRODUCT | Treatment with Budesonide/Glycopyrronium/FormoterolFumarate |
| GFF | COMBINATION_PRODUCT | Treatment with Glycopyrronium/Formoterol Fumarate |
Inclusion Criteria: Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed consent form at Visit 1. * COPD Diagnosis: Subjects with an established clinical history of COPD * Screening clinical laboratory tests must be acceptable to the Investigator. * Screening...