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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Interventions

  • Drug: 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
  • 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

Arms, Groups and Cohorts

  • Experimental: AP301
    • Treatment group
  • Placebo Comparator: Saline solution

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • EVLW
    • Time Frame: 7 days or until extubation
    • Measurement of extravascular lung water

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Apeptico Forschung und Entwicklung GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Walter Klepetko, Univ.Prof.Dr.med.univ., Principal Investigator, Medical University of Vienna

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