NCT03322787: HFO

Effect of Exercise Training Under HFO Device on Endurance Tolerance in Patients With COPD and CRF: a Randomized Controlled Study.

Completed NA Last updated 29 May 2019

What this trial tests

NA trial testing HFO in COPD in 171 participants. Completed in 31 March 2019.

Timeline

6 November 2017

Primary endpoint
8 December 2018

31 March 2019

Quick facts

Lead sponsor	Istituti Clinici Scientifici Maugeri SpA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	screening
Enrollment	171
Start date	6 November 2017
Primary completion	8 December 2018
Estimated completion	31 March 2019
Sites	1 location across Italy

Drugs / interventions tested

• HFO

Conditions studied

• COPD — all drugs for COPD →

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Who can join

18 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current literature clearly shows the benefit of pulmonary rehabilitation in symptomatic COPD (Trooster,2005). However, these patients are frequently unable to sustain a work-load sufficiently high to obtain a full benefit on exercise tolerance (Trooster,2005). Especially in patients with Chronic Respiratory Failure (CRF), the development of hypoxia (O'Donnel,2001) and the increase of dead space (Elbehairy,2015) during effort explain the out-of-proportion increase in ventilation leading to an early achievement of the ventilatory reserve. Recent studies on heated and humidified high flow oxygen (HFO) delivered through nasal cannula, show several positive effects on breathing pattern and ventilatory efficiency, mostly in critical care setting and at rest (Spoletini,2015). Some recent physiological studies have evidenced that high flows of humidified oxygen improve exercise performance in patients with COPD and severe oxygen dependency, in part by enhancing oxygenation (Chatila,2004). Recently, a pilot study by our group showed that HFO may improve the exercise performance in severe COPD patients with ventilatory limitation. This effect is associated to an improvement of oxygen saturation (SatO2) and perceived symptoms at iso-time (Cirio,2016). No clinical studies are available about the use of HFO during exercise training. The investigators hypothesize that, in severe COPD patients with CRF and exercise limitation , the use of HFO could improve the efficiency of ventilation, leading to an increase in the patient's exercise performance and outcome.

Primary aim will be to evaluate in patients COPD with CRF the difference in the endurance tolerance improvement (expressed in minutes) after an high intensity training program, at iso-FiO2, using HFO with respect to usual oxygen administration by " Venturi Mask" .

Secondary objectives will be to study effectiveness of HFO with respect to "Venturi Mask" in terms of improvement of meters of 6 Minute Walking Test, dyspnea at rest, peripheral and respiratory muscle strength,blood gases, motor and respiratory disability,quality of life,impact of the disease and patients satisfaction.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Evidence of Nasal High-Flow Therapy in Chronic Obstructive Pulmonary Disease Patients.
   Elshof J, Duiverman ML. · · 2020 · cited 23× · PMID 31991408 · DOI 10.1159/000505583