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

INTERVENTION: Product Name: AP301 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: AP301 Current Sponsor code: AP301 Other descriptive name: AP301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use CONDITION: Primary Graft Dysfunction (PGD) after lung transplantation Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To assess the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) according to ISHLT (International Society for Heart and Lung Transplantation) criteria in patients after primary LuTX in comparison to placebo.; Secondary Objectives; ; Primary end point(s): The primary efficacy variable will be 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 Objective: To assess:; • recipient mortality at 30 days after transplantation (%),; • duration of intubation ; • requirement of mechanical ventilation,; • length of ICU stay,; • incidence of acute rejections,; • freedom of chronic lung allograft dysfunction (CLAD),; • graft survival within 30 days,; • local and systemic safety and tolerability of AP301. Timepoint(s) of evaluation of this end point: 72 hours after diagnosis of PGD SECONDARY OUTCOME: Secondary end point(s): 1. Oxygenation index until day 7 of treatment or until extubation.; 2. EVWL (measured with PiCCO® technique) until day 7 of treatment; 3. Changes in ?pO2 during treatment; 4. recipient mortality at 30 days after transplantation (%),; 5. duration of intubation ; 6. requirement of mechanical ventilation,; 7. length of ICU stay,; 8. incidence of acute rejections,; 9. freedom of chronic lung allograft dysfunction (CLAD); 10. graft survival within 30 days; 11. overall survival within 30 days; Timepoint(s) of evaluation of this end point: up to 7 days after diagnosis 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range