Nasal high-flow therapy for COPD exacerbations

Is this trial a fit for you?

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

What this trial studies

This study investigates the efficacy of nasal high-flow therapy (nHFT) in enhancing recovery from COPD exacerbations in hospitalized patients. It is a multicenter, randomized controlled trial comparing nHFT to standard care, aiming to include 136 patients. The study will also explore the underlying mechanisms of nHFT through neuromechanical and anatomical investigations. By understanding how nHFT works, the study seeks to optimize its application for COPD patients experiencing exacerbations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients have to fulfil all of the following inclusion criteria:

* History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking.
* Being admitted to the hospital with a COPD exacerbation
* Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34
* At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
* Written informed consent is obtained

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* No lung function data available
* The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
* Inability to comply with the tests
* The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).

Where it's running

• Rijnstate Hospital
  Arnhem, Netherlands Recruiting
• Albert Schweizer ziekenhuis
  Dordrecht, Netherlands Recruiting
• University Medical Center Groningen
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Marieke L Duiverman, MD PhD
• Email: m.l.duiverman@umcg.nl
• Phone: 0031-50-3613200

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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.