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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