Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

Pilot Study to Investigate the Clinical Effect of Orally Inhaled AP301 on Treatment of Primary Graft Dysfunction (PGD) in Mechanically Ventilated Patients After Primary Lung Transplantation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02095626

Enrollment

Registered

2014-03-26

Start date

2013-06-30

Completion date

2015-03-31

Last updated

2019-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PGD Primary Graft Dysfunction

Keywords

Peptide

Brief summary

The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

Interventions

DRUGAP-301

orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days

DRUGsaline solution

placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Being a male or female recipient on the AKH's waiting list for primary single or double LuTX * PGD score ≥ 1 within 72 hours after LuTX * Informed consent is available

Exclusion criteria

* History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product * Postoperative ECMO support * Paediatric /adolescent recipients (\< 18 years) * Lobar transplantation * Retransplantation * Combined solid organ transplants * Participation in other drug trials

Design outcomes

Primary

Measure	Time frame	Description
P/F ratio	7 days	The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient

Secondary

Measure	Time frame	Description
EVLW	7 days or until extubation	Measurement of extravascular lung water

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026