BREATHE-3
Research type
Research Study
Full title
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung (BREATHE-3)
IRAS ID
354379
Contact name
Leland Keyt
Contact email
Sponsor organisation
Apreo Health, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Emphysema is a lung disease that results from damage to the walls of the alveoli of the lungs. A blockage (obstruction) may develop, which traps air inside the lungs. This multi-centre study is being carried out to assess the safety and efficacy of the Apreo BREATHE System when used to support native airways and regional release of trapped air in the treatment of adult Chronic obstructive pulmonary disease (COPD) patients with emphysema suffering from shortness of breath (dyspnea) due to pulmonary hyperinflation despite optimal medical management.
Up to 250 participants will be recruited at up to 25 sites across the USA and Europe (approximately 20 United States centres and approximately 5 European centres).
This is a prospective, randomised, two arm, parallel group, concurrently controlled, open-label, multi- centre clinical trial following subjects to 3 years.
Each site will participate in a Roll-In phase prior to participation in the randomised phase of the study. Each site will enrol up to 2 subjects in this phase. Efficacy results from the Roll-In cohort will be evaluated separately from the randomised cohort. Safety results may be pooled with the randomized cohort. Up to 50 subjects may be enrolled into the Roll-In cohort.
In the Randomised cohort, subjects will be randomised to either a Treatment or Control group in a 2:1 ratio.
REC name
West of Scotland REC 4
REC reference
25/WS/0172
Date of REC Opinion
16 Jan 2026
REC opinion
Further Information Favourable Opinion