Functional Respiratory Imaging Study (DARWiIN)
Phase 3
Completed
NCT04876677
| Condition | Chronic Obstructive Pulmonary Disease |
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| Phase | Phase 3 |
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| Sponsor | Chiesi Farmaceutici S.p.A. |
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| Status | Completed |
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| Enrollment | 25 participants |
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| Interventions | Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB) |
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| Start date | May 18, 2021 |
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| Completion date | Jan 3, 2022 |
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| Results posted | Apr 9, 2026 |
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Summary
The objective of this clinical study was to evaluate the tolerability, safety, and efficacy of stepping up from fluticasone propionate (FP)/salmeterol (SLM) dry-powder inhaler (DPI) (SERETIDE™ DISKUS™) to extrafine beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) DPI (CHF5993) and to assess its effect on airway geometry and lung ventilation in subjects with advanced Chronic Obstructive Pulmonary Disease (COPD). Primary Objectives: * Untrimmed siVaw for distal region at TLC - actual value for V2 pre-dose and V3 pre-dose * Trimmed siRaw for distal region at TLC - actual value for V2 pre-dose and V3 pre-dose Secondary Objectives: * Untrimmed siVaw for distal region at TLC and FRC - actual value for V2 pre-dose, V2 post-dose, V3 pre-dose and V3 post-dose * Trimmed siRaw for distal region at TLC and FRC - actual value for V2 pre-dose, V2 post-dose, V3 pre-dose and V3 post-dose * Safety assessment through the evaluation of treatment-emergent adverse events (TEAEs).
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days) · liters
| CHF5993 DPI 100/6/12.5 μg - PP Population | 1.4088 ± 0.6647 liters |
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| CHF5993 DPI 100/6/12.5 μg - PP Population | 1.3550 ± 0.6014 liters |
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| p-value | = 0.4521 |
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| Adjusted Mean Change | -3.81 (95% CI -13.44–6.89) |
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Trimmed Airway Volume (siRaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
V2 pre-dose (i.e. baseline, assessed at week 6 ± 2 days), V3 pre-dose (assessed at week 12 ± 2 days) · cmH₂O·s
| CHF5993 DPI 100/6/12.5 μg - PP Population | 0.7160 ± 0.4034 cmH₂O·s |
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| CHF5993 DPI 100/6/12.5 μg - PP Population | 0.8492 ± 0.5947 cmH₂O·s |
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| p-value | = 0.4871 |
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| Adjusted Mean Change | 11.95 (95% CI -19.67–56.02) |
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Open in BENITIONS
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