Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Фаза 3
Завершено
NCT01917331
| Заболевание | Chronic Obstructive Pulmonary Disease |
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| Фаза | Фаза 3 |
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| Спонсор | Chiesi Farmaceutici S.p.A. |
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| Статус | Завершено |
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| Участники | 1,368 участн. |
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| Вмешательство | Beclometasone/Formoterol/Glycopyrrolate, Beclometasone/Formoterol |
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| Дата начала | 21.03.2014 |
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| Дата завершения | 14.01.2016 |
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| Публикация результатов | 3.06.2026 |
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Кратко
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.
1_Change From Baseline in Pre-dose Morning Forced Expiratory Volume in the 1st Second (FEV1) -- at Week 26
Baseline (Week 0), Week 26. · litre
| CHF 5993 pMDI | 0.082 litre |
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| CHF 1535 pMDI Foster® | 0.001 litre |
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| p-value | < 0.001 |
| Adjusted mean difference | 0.081 (95% CI 0.052–0.109) |
2_Change From Baseline in 2-hour Post-dose FEV1 -- at Week 26
Baseline (Week 0) to 2-hour post-dose at Week 26. · litre
| CHF 5993 pMDI | 0.261 litre |
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| CHF 1535 pMDI Foster® | 0.145 litre |
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| p-value | < 0.001 |
| Adjusted mean difference | 0.117 (95% CI 0.086–0.147) |
3_Transition Dyspnoea Index (TDI) Focal Score -- at Week 26
Baseline (Week 0), Week 26. · score on a scale
| CHF 5993 pMDI | 1.71 score on a scale |
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| CHF 1535 pMDI Foster® | 1.50 score on a scale |
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| p-value | = 0.160 |
| Adjusted mean difference | 0.21 (95% CI -0.08–0.51) |
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