Phase 3
Completed N=25
Functional Respiratory Imaging Study (DARWiIN)
Source: ClinicalTrials.gov NCT04876677 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
4citations · ~1 / year
The effect of inhaled extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide on distal and central airway indices, assessed using Functional Respiratory Imaging in COPD (DARWiIN).
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).
Linked Publications
-
The effect of inhaled extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide on distal and central airway indices, assessed using Functional Respiratory Imaging in COPD (DARWiIN).
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 |
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.
Data sourced from ClinicalTrials.gov (NCT04876677) and the linked publication. 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. Informational only — not medical advice.