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

Apeptico

Status and phase: Completed; Phase 2

Conditions: PGD Primary Graft Dysfunction

Treatments: Drug: AP-301; Drug: saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02095626

2013-000716-21 (EudraCT Number)

AP-301-III-001

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

AP301

Experimental group

Description:

Treatment group

Treatment:

Drug: AP-301

Saline solution

Placebo Comparator group

Treatment:

Drug: saline solution