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

Phase 2CompletedNCT02095626

Apeptico Forschung und Entwicklung GmbH20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PGD Primary Graft Dysfunction

Interventions

AP-301DRUG

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

saline solutionDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Thoracic Surgery MedUni Vienna

Vienna, Austria

Outcomes

Primary Outcomes

P/F ratio

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

Time frame: 7 days

Secondary Outcomes

EVLW

Measurement of extravascular lung water

Time frame: 7 days or until extubation

Data from ClinicalTrials.gov

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