NCT04876677

Functional Respiratory Imaging Study (DARWiIN)

Open Label, Prospective Study to Evaluate the Effect of Step-up From Non-extra Fine Inhaled Corticosteroids/Long Acting Beta2 Agonist (ICS/LABA) Dry Powder Inhaler (DPI) to Extra Fine Triple Therapy With CHF5993 DPI on Airway Geometry and Lung Ventilation Using Functional Respiratory Imaging (FRI) in Subjects With Advanced Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The study was an open-label, single-arm, prospective study of a duration of approximately 14 weeks per patient, aimed at evaluating the effect of step-up from non-extra fine ICS/LABA DPI to extra fine triple therapy with CHF5993 DPI on airway geometry and lung ventilation using Functional Respiratory Imaging (FRI) in subjects with advanced COPD. All parameters assessed in this trial were evaluated at the following visits: * Visit 1: Baseline Visit (Run-In Start): Screening and initiation of SERETIDE™ DISKUS™ DPI. * Visit 2 (Transition to CHF5993 DPI): End of the 6-week run-in period. * Visit 3 (End of Treatment): Completion of the 6-week CHF5993 DPI treatment phase. The screening visit (V1) was followed by a 6-week run-in phase where participants were stabilized on SERETIDE™ DISKUS™ DPI 500/50μg, one inhalation twice daily (b.i.d.). This regimen provided a total daily dose of 1 mg of fluticasone propionate (FP) and 100 µg of salmeterol (SLM). At the screening visit (V1), patients received specific training on the proper use of the inhalation technique using In-Check Dial for both SERETIDE™ DISKUS™ and CHF5993 NEXThaler®. More precisely, to familiarize participants with the technique and ensure repeatable inhalations one assessment was set up for DISKUS™ resistance and the other for NEXThaler® resistance. At the end of the run-in period (V2), patients transitioned to a 6-week treatment phase with CHF5993 DPI (until V3). A follow-up call was conducted 2 weeks ± 2 days after V3 for males and women of non-childbearing potential, FRI, spirometry, and plethysmography were used to evaluate airway geometry, lung ventilation, and lung function.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB)	Treatment period: two inhalations b.i.d. of CHF5993 DPI 100/6/12.5 µg, for a total daily dose of BDP/FF/GB 400/24/50 µg. All the eligible patients were treated

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2021-05-06
• Last updated: 2026-04-09
• Results posted: 2026-04-09

Locations

8 sites across 2 countries: Belgium, Hungary