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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06075095 | A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD | PHASE3 | COMPLETED | 297 | — | — | Jan 11, 2024 | Aug 12, 2025 | Aug 27, 2025 | 87 | United States, Argentina +12 |
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 1: BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA |
| Treatment Sequence 2 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 2: BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg |
| Treatment Sequence 3 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 3: BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA |
| Treatment Sequence 4 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 4: BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg |
| Treatment Sequence 5 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 5: Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg |
| Treatment Sequence 6 | EXPERIMENTAL | Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions in the following sequence. Sequence 6: Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg |
| Name | Type | Description |
|---|---|---|
| BGF MDI HFO 320/14.4/9.6μg | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) |
| BGF MDI HFA 320/14.4/9.6 μg | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart): |
| Placebo MDI HFA | DRUG | Study interventions will be administered orally via MDI as 2 inhalations BID (every morning and evening, approximately 12 hours apart) |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Age 1. Participants must be 40 to 80 years inclusive at the time of signing the ICF. Type of Participant and Disease Characteristics 2. Participants who have a documented history...