Clinical trial Recruiting at 2 sites Interventional Ages 18 and up

Comparing new nasal interface with standard cannula for COPD patients

Official title: Asymmetric (DUET) Versus Conventional Nasal High Flow Interface for Management of Hypercapnic Patients With Mild to Moderate Acute Exacerbation of COPD: A Randomized, Crossover Clinical Trial

Run by Larissa University Hospital · NCT05829083 · Data updated 2026-11-12

This study is testing a new type of nasal breathing device against a standard one to see which helps people with COPD feel better during a flare-up.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorLarissa University Hospital
Academic / other
Locations2 sites (Athens and 1 other locations)
StatusRecruiting
StartedJuly 18, 2023
Main results expectedDecember 1, 2025
Study endsDecember 1, 2025
Registry record updatedSeptember 10, 2025
Trial IDNCT05829083 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients presenting with acute exacerbation of COPD and mild-to-moderate acute hypercapnic respiratory failure.

Probably not a fit

Patients with severe facial deformities, imminent intubation needs, or severe hemodynamic instability are unlikely to benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of a new asymmetric nasal high flow interface against a conventional high flow nasal cannula in patients experiencing acute exacerbation of COPD. Participants will wear each type of cannula for three hours, with a 30-minute break in between, while various clinical parameters and arterial blood samples are collected. The study will assess differences in carbon dioxide levels, respiratory rate, dyspnea, and the need for advanced oxygen therapy. The research is conducted at two hospitals in Greece, following a randomized crossover design.

Why it matters

Potential benefit: If successful, this study could lead to improved management of COPD exacerbations, reducing carbon dioxide levels and enhancing patient comfort.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving respiratory outcomes in COPD patients.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* acute exacerbation of COPD (defined as any worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to change in medication)
* mild-to-moderate acute hypercapnic respiratory failure (defined as 7.35\>pH\>7.25 and arterial CO2 tension (PaCO2) \>45 mmHg)

Exclusion Criteria:

* acute on chronic hypercapnic respiratory failure
* severe facial deformity, facial burns, fixed upper airway obstruction
* indication for imminent intubation and invasive mechanical ventilation (i.e. respiratory or cardiac arrest, diminished consciousness (Glasgow coma score \<8)
* psychomotor agitation inadequately controlled by sedation
* massive aspiration
* persistent inability to remove respiratory secretions
* severe haemodynamic instability unresponsive to fluids and vasoactive drugs
* severe ventricular or supraventricular arrhythmias
* life threatening hypoxaemia

Where it's running

  • Sotiria General Hospital
    Athens, Greece
    Recruiting
  • University Hospital of Larissa
    Larissa, Greece
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.