NCT03068026

Influence of the VitaBreath on Exercise Tolerance in COPD

Completed NA Last updated 5 March 2021

What this trial tests

NA trial testing VitaBreath in Chronic Obstructive Pulmonary Disease in 24 participants. Completed in 30 September 2018.

Timeline

6 June 2017

Primary endpoint
18 June 2018

30 September 2018

Quick facts

Lead sponsor	North Tyneside General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	6 June 2017
Primary completion	18 June 2018
Estimated completion	30 September 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• VitaBreath
• Pursed Lip Breathing technique

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

North Tyneside General Hospital

Who can join

Adults 40 to 80, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation".

Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements.

Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.

Publications & conference data

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

1. Intermittent Use of Portable NIV Increases Exercise Tolerance in COPD: A Randomised, Cross-Over Trial.
   Vogiatzis I, Chynkiamis N, Armstrong M, Lane ND, et al · · 2019 · cited 10× · PMID 30650617 · DOI 10.3390/jcm8010094