Influence of the Vitabreath on exercise tolerance in COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Respiratory

• Registration Number: ISRCTN13097622
• Lead Sponsor: Philips

Brief Summary

2019 results in https://pubmed.ncbi.nlm.nih.gov/30650617/ (added 26/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-28
• Study Completion: 2018-04-30
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Male or female aged 40 years or older
2. Current or previous smoking history, 10 or more pack years
3. Spirometry confirmed stable COPD (GOLD stages II-IV) under optimal medical therapy
4. Exhibit substantial exercise-induced dynamic hyperinflation (?IC baseline > 0,2 L)

Exclusion Criteria

1. Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator
2. Moderate or severe COPD exacerbation within 6 weeks
3. Unstable cardiac arrhythmia
4. Unstable ischaemic heart disease, including myocardial infarction within 6 weeks
5. Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy
6. Uncontrolled hypertension
7. Uncontrolled hypotension (SBP<85mmHg)
8. Uncontrolled diabetes
9. Intolerance of the VitaBreath device

Study & Design

• Study Type: Interventional
• Study Design: Not specified