Functional Respiratory Imaging Study (DARWiIN)

Фаза 3 Завершено NCT04876677

Кратко

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

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

Открыть в BENITIONS Открыть на ClinicalTrials.gov

Другие исследования по этому заболеванию

• 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

Все исследования