Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation
Phase 2
Completed
- Conditions
- PGD Primary Graft Dysfunction
- Interventions
- Drug: saline solution
- Registration Number
- NCT02095626
- Lead Sponsor
- Apeptico Forschung und Entwicklung GmbH
- Brief Summary
The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AP301 AP-301 Treatment group Saline solution saline solution -
- Primary Outcome Measures
Name Time Method P/F ratio 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 Outcome Measures
Name Time Method EVLW 7 days or until extubation Measurement of extravascular lung water
Trial Locations
- Locations (1)
Division of Thoracic Surgery MedUni Vienna
🇦🇹Vienna, Austria