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

Phase 2

Completed

• Conditions: PGD Primary Graft Dysfunction
• Interventions: Drug: AP-301; Drug: saline solution

• Registration Number: NCT02095626
• Lead Sponsor: Apeptico Forschung und Entwicklung GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AP301	AP-301	Treatment group
Saline solution	saline solution	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
EVLW	7 days or until extubation	Measurement of extravascular lung water

Trial Locations

Locations (1)

Division of Thoracic Surgery MedUni Vienna; 🇦🇹 Vienna, Austria