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Functional Respiratory Imaging Study (DARWiIN)

NCT04876677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-09

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, MD, PhD · Medlmprove BV, Kontich, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-01-03
Completion
2022-01-03

Countries

  • Belgium
  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04876677 on ClinicalTrials.gov