Phase 3 N=25 Treatment

Functional Respiratory Imaging Study (DARWiIN)

Chronic Obstructive Pulmonary Disease

Bottom Line

View on ClinicalTrials.gov: NCT04876677 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose — 1.4088; 1.3550 liters — p== 0.4521

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB) (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Chiesi Farmaceutici S.p.A.
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose	1.4088; 1.3550	= 0.4521
PRIMARY Trimmed Airway Volume (siRaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose	0.7160; 0.8492	= 0.4871
SECONDARY Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose	1.4088; 1.8706; 1.3550; 1.9805	<0.0001 sig
SECONDARY Untrimmed siVaw for Distal Region at Functional Residual Capacity (FRC) - Actual Value for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose	0.6321; 1.0204; 0.6982; 1.0442	0.0636
SECONDARY Trimmed siRaw Via Functional Respiratory Imaging (FRI) for Distal Region at Total Lung Capacity (TLC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose	0.7160; 0.3685; 0.8492; 0.3121	=0.0002 sig
SECONDARY Trimmed siRaw for Distal Region Using Functional Respiratory Imaging (FRI) at Functional Residual Capacity (FRC) - Actual Values for V2 Pre-dose, V2 Post-dose, V3 Pre-dose and V3 Post-dose	0.4981; 0.2200; 0.3625; 0.1889	0.0261 sig

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).

Eligibility Criteria

Inclusion Criteria

Patient's signed ICF obtained prior to any study-related procedure;
Male or female ≥40 years of age;
Current smokers or ex-smokers of at least 10 pack-years, calculated as (number of cigarettes/day * number of years)/20 (e-cigarettes smoking could not be used to calculate pack-year history);
Established diagnosis of COPD according to the 2020 GOLD Report, prior to the V1;
Post-BD FEV1/forced vital capacity (FVC) 450 ms and female patients with a QTcF >470 ms at V1 were not eligible;
Laboratory abnormalities: patients with clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease that could, in the judgement of the Investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study;
Alcohol/drug abuse: patients with a known or suspected history of alcohol and/or substance/drug abuse within 12 months prior to screening; or had a positive drug test at screening or V2;
Participation in investigational study: patients who had received any investigational drug within the 30 days or a more appropriate time as determined by the Investigator (e.g., approximately five half-lives of the investigational drug, whatever was longer);
Contra-indications to investigational medicinal products (IMPs), based on Investigator judgement;
Hypersensitivity: history of hypersensitivity to any of the study medications components or a history of other allergy that in the opinion of the Investigator contraindicated the patient's participation;
Patients mentally or legally incapacitated or patients accommodated in an establishment as a result of an official or judicial order;
Documented Coronavirus disease 2019 (COVID-19) diagnosis or its complications which had not resolved within 14 days prior to screening;
Positive molecular COVID-19 test within the last 72 h before the remaining of screening activities.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04876677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.