Functional Respiratory Imaging Study (DARWiIN)

3期已完成 NCT04876677

适应症	Chronic Obstructive Pulmonary Disease
分期	3期
申办方	Chiesi Farmaceutici S.p.A.
状态	已完成
受试者人数	25 人
干预（药物）	Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB)
开始日期	2021年5月18日
完成日期	2022年1月3日
结果公布日	2026年4月9日

摘要

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
CHF5993 DPI 100/6/12.5 μg - PP Population	1.3550 ± 0.6014 liters

p-value	= 0.4521
Adjusted Mean Change	-3.81 (95% CI -13.44–6.89)

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
CHF5993 DPI 100/6/12.5 μg - PP Population	0.8492 ± 0.5947 cmH₂O·s

p-value	= 0.4871
Adjusted Mean Change	11.95 (95% CI -19.67–56.02)

在 BENITIONS 中查看查看 ClinicalTrials.gov 原文

同一适应症的其他试验

Feasibility, Safety and Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and — University of Tennessee Graduate School of Medicine
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster — Chiesi Farmaceutici S.p.A.
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®T — Chiesi Farmaceutici S.p.A.
Tiotropium/Salmeterol Inhalation Powder in COPD — Boehringer Ingelheim
Risk Factors, Costs, and Impacts of ED Boarding — University of Maryland, Baltimore
Inhaled Treprostinil in Participants With Pulmonary Hypertension Due to Chronic Obstructiv — United Therapeutics

全部试验

本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。

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