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

NCT ID: NCT02095626

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-03-31

Brief Summary

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

Conditions

PGD Primary Graft Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AP301

Treatment group

Group Type: EXPERIMENTAL

AP-301

Intervention Type: DRUG

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 solution

Group Type: PLACEBO_COMPARATOR

saline solution

Intervention Type: DRUG

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

Interventions

AP-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

Intervention Type: DRUG

saline solution

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apeptico Forschung und Entwicklung GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter Klepetko, Univ.Prof.Dr.med.univ.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Division of Thoracic Surgery MedUni Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

2013-000716-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AP-301-III-001

Identifier Type: -

Identifier Source: org_study_id