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OpenTrials
Completed

NCT Number: NCT02095626

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

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

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Key information

Conditions

PGD Primary Graft Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Division of Thoracic Surgery MedUni Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AP-301

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

Drug

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

Primary outcomes

  1. P/F ratio

    Time frame: 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 outcomes

  1. EVLW

    Time frame: 7 days or until extubation

    Measurement of extravascular lung water

Sponsors and collaborators

Lead sponsor

Apeptico Forschung und Entwicklung GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.