BENITIONSClinical Trial Intelligence

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Фаза 3 Завершено NCT01917331

ЗаболеваниеChronic Obstructive Pulmonary Disease
ФазаФаза 3
СпонсорChiesi Farmaceutici S.p.A.
СтатусЗавершено
Участники1,368 участн.
ВмешательствоBeclometasone/Formoterol/Glycopyrrolate, Beclometasone/Formoterol
Дата начала21.03.2014
Дата завершения14.01.2016
Публикация результатов3.06.2026

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 pMDI0.082 litre
CHF 1535 pMDI Foster®0.001 litre
p-value< 0.001
Adjusted mean difference0.081 (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 pMDI0.261 litre
CHF 1535 pMDI Foster®0.145 litre
p-value< 0.001
Adjusted mean difference0.117 (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 pMDI1.71 score on a scale
CHF 1535 pMDI Foster®1.50 score on a scale
p-value= 0.160
Adjusted mean difference0.21 (95% CI -0.08–0.51)

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