NCT05854550 (BREATHE-1) is a NA clinical trial of Apreo Implant Group in Emphysema or COPD, sponsored by Apreo Health, Inc..

Who is sponsoring NCT05854550?

NCT05854550 is sponsored by Apreo Health, Inc..

What drugs are being tested in NCT05854550?

Interventions in NCT05854550: Apreo Implant Group.

What condition does NCT05854550 study?

NCT05854550 studies Emphysema or COPD.

Is NCT05854550 still recruiting?

NCT05854550 is currently completed. Last updated 31 March 2026.

Last reviewed 2026-03-31 · How we verify

NCT05854550: BREATHE-1

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

First in Human Study to Assess an Implant to Treat Severe Emphysema

Completed NA Last updated 31 March 2026

What this trial tests

NA trial testing Apreo Implant Group in Emphysema or COPD in 48 participants. Completed in 16 February 2026.

Timeline

5 May 2023

Primary endpoint
8 October 2024

16 February 2026

Quick facts

Lead sponsor	Apreo Health, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	5 May 2023
Primary completion	8 October 2024
Estimated completion	16 February 2026
Sites	2 locations across Australia

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. The main questions it aims 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

2 peer-reviewed publications 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
ERJ Advances: interventional bronchoscopy.
Garner JL, Shah PL, Herth F, Slebos DJ. · · 2024 · cited 3× · PMID 38991719 · DOI 10.1183/13993003.01946-2023

Verify or expand the search:

Other trials of Apreo Implant Group

Trials testing the same drug.

NCT05949645 — Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema · NA · active not recruiting

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
NCT05949645 — Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema · NA · active not 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
NCT05949645 — Study to Assess Safety, Feasibility, and Preliminary Efficacy of the Apreo Implant for Severe Emphysema · NA · active not recruiting

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 NCT05854550 (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/NCT05854550.

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