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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06283966 | A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease | PHASE3 | RECRUITING | 5,000 | — | — | Feb 21, 2024 | Dec 3, 2027 | May 13, 2026 | 920 | United States, Argentina +35 |
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
| Arm | Type | Description |
|---|---|---|
| BGF arm | EXPERIMENTAL | BGF MDI 320/14.4/9.6 μg BID |
| GFF arm | EXPERIMENTAL | GFF MDI 14.4/9.6 μg BID |
| Name | Type | Description |
|---|---|---|
| BGF MDI 320/14.4/9.6 μg | DRUG | Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension |
| GFF MDI 14.4/9.6 μg | DRUG | Glycopyrronium and formoterol fumarate pressurized inhalation suspension |
Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% ...