NCT05949645 (BREATHE-2) is a NA clinical trial of Apreo Implant Group in Emphysema or COPD, sponsored by Apreo Health, Inc..

Who is sponsoring NCT05949645?

NCT05949645 is sponsored by Apreo Health, Inc..

What drugs are being tested in NCT05949645?

Interventions in NCT05949645: Apreo Implant Group.

What condition does NCT05949645 study?

NCT05949645 studies Emphysema or COPD.

Is NCT05949645 still recruiting?

NCT05949645 is currently active, enrolled. Last updated 31 March 2026.

Last reviewed 2026-03-31 · How we verify

NCT05949645: BREATHE-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema

Active, enrolled NA Last updated 31 March 2026

What this trial tests

NA trial testing Apreo Implant Group in Emphysema or COPD in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 August 2023

Primary endpoint
8 October 2024

1 June 2026

Quick facts

Lead sponsor	Apreo Health, Inc.
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 August 2023
Primary completion	8 October 2024
Estimated completion	1 June 2026
Sites	3 locations across Austria, Netherlands, United Kingdom

Drugs / interventions tested

Apreo Implant Group

Conditions studied

Emphysema or COPD — all drugs for Emphysema or COPD →

Sponsor

Apreo Health, Inc. — full company profile →

Who can join

Adults 35 to 80, any sex, with Emphysema or COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to test the feasibility of an implant for severe emphysema in up to 30 participants at up to 5 study centers located in Europe and the United Kingdom. The main questions this clinical trial aim to answer are: Is it safe? Does it work? Participants who meet eligibility criteria will have up to two procedures 30 days apart, in which up to 3 implants will be placed in each lung during the procedure(s). Participants will be asked to return for follow-up visits at 30 days, and 3, 6, and 12 months after the procedure(s).

Publications & conference data

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

Airway Scaffolds for Emphysema-related Hyperinflation: Six-Month Results from the BREATHE Trial.
Tana A, Valipour A, Ing A, Steinfort DP, et al · · 2025 · cited 4× · PMID 40387356 · DOI 10.1164/rccm.202502-0378oc

Verify or expand the search:

Other trials of Apreo Implant Group

Trials testing the same drug.

NCT05854550 — First in Human Study to Assess an Implant to Treat Severe Emphysema · NA · completed

Other recruiting trials for Emphysema or COPD

Currently open trials in the same condition.

NCT06035120 — An Evaluation of the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema · NA · recruiting
NCT06249529 — Airway Bypass - Safety and Feasibility Study · EARLY_PHASE1 · recruiting
NCT06163131 — The Effect of Treatment of Emphysema With Endobronchial Valves on the Diaphragm Mobility · recruiting
NCT06304207 — Telehealth and Onsite Maintenance Exercise in Chronic Lung Disease · NA · recruiting
NCT06068647 — Ultrasound and Respiratory Physiological Signals in Lung Diseases · NA · recruiting

Other Apreo Health, Inc. trials

Trials by the same sponsor.

NCT06891755 — Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3 · NA · recruiting
NCT05854550 — First in Human Study to Assess an Implant to Treat Severe Emphysema · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05949645 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Apreo Health, Inc.
Last refreshed: 31 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05949645.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing