Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

3상 완료 NCT03197818

대상 질환	COPD
임상 단계	3상
스폰서	Chiesi Farmaceutici S.p.A.
상태	완료
참여자 수	708 명
중재(약물)	CHF 5993 100/6/12.5 µg, 160 µg budesonide + 4.5 µg formoterol fumarate
시작일	2016년 12월 14일
완료일	2020년 5월 26일
결과 공개일	2026년 5월 27일

요약

Primary Objective • To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in the first second of a forced vital capacity manoeuvre \[FEV1\] and 2-hour post-dose morning FEV1 at Week 24). Secondary Objectives Key secondary objective: • To demonstrate the superiority of CHF 5993 pMDI over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24) in the subgroup of Chinese population. Other secondary objectives: * To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures; * To collect data in order to assess the impact of study treatments on health economic outcomes; * To assess the safety and the tolerability of the study treatments.

Change From Baseline in Pre-dose Forced Expiratory Volume Within the First Second (FEV1) at Week 24

Week 24 (Visit 6) · Liters

CHF 5993 100/6/12.5 µg - ITT Population	0.030 Liters
Symbicort Turbuhaler 160/4.5 µg - ITT Population	-0.032 Liters

p-value	< 0.001
adjusted mean difference	0.062 (95% CI 0.038–0.085)

Change From Baseline in 2-hour Post-dose FEV1 at Week 24

Week 24 (Visit 6) · Liters

CHF 5993 100/6/12.5 µg - ITT Population	0.185 Liters
Symbicort Turbuhaler 160/4.5 µg - ITT Population	0.072 Liters

p-value	< 0.001
adjusted mean difference	0.113 (95% CI 0.087–0.140)

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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전체 임상

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