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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04078126 | Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing. | PHASE3 | COMPLETED | 35 | — | — | Sep 10, 2019 | Dec 30, 2020 | Mar 18, 2022 | 4 | Germany |
Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose.
| Arm | Type | Description |
|---|---|---|
| Budesonide and formoterol fumarate (MDI BFF) | EXPERIMENTAL | Subject treated with MDI BFF followed by washout period |
| Symbicort Turbuhaler | ACTIVE_COMPARATOR | Subject treated with Symbicort followed by washout period |
| Name | Type | Description |
|---|---|---|
| BFF | COMBINATION_PRODUCT | Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler) |
| Symbicort Turbuhaler | COMBINATION_PRODUCT | Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler) |
Key Inclusion Criteria: 1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) 3. Require COPD maintenance therapy: all subjects mu...