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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05573464 | A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease | PHASE3 | COMPLETED | 559 | — | — | Sep 27, 2022 | Mar 26, 2024 | Sep 19, 2025 | 91 | United States, Argentina +7 |
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD
To assess the safety and tolerability of BGF MDI HFO as compared to BGF MDI HFA in participants with moderate to very severe COPD. Adverse events of special interest in this study are respiratory events such as dysphonia, cough, dyspnea, wheezing, paradoxical bronchospasm, bronchospasm, and COPD exacerbations.
| Arm | Type | Description |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6μg | EXPERIMENTAL | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze) |
| BGF MDI HFA 320/14.4/9.6 μg | ACTIVE_COMPARATOR | Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA |
| Name | Type | Description |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6 μg | DRUG | Budesonide, Glycopyrronium, and Formoterol Fumarate |
| BGF MDI HFA 320/14.4/9.6 μg | DRUG | Budesonide, Glycopyrronium, and Formoterol Fumarate |
Inclusion Criteria: 1. Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF; 2. Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines; 3. Participants who have been regul...