Acute Pulmonary oedema
Conditions
Interventions
Product Name: AP301
Pharmaceutical Form: Powder for nebuliser solution
CAS Number: 8000019-76-3
Current Sponsor code: AP301
Other descriptive name: human tumour necrosis factor alpha-derived peptide C
Sponsors
Apeptico Forschung und Entwicklung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age = 18 - intubated and mechanically ventilated male and female patients of the Intensive Care Units of the Department of Anesthesia, General Intensive Care and Pain Control - meets the criteria of ALI (as defined by the American-European Consensus Conference on ALI/ ARDS): - Onset of ALI within 48 hours - Bilateral infiltrates seen on frontal chest radiograph - PCWP = 18 mm Hg or no clinical evidence of left atrial hypertension - paO2/ FiO2 ratio = 300 mm Hg - EVLW in PiCCO® at screening = 8 ml/PBW - Meeting criteria for extensive hemodynamic monitoring according to investigators discretion - Informed consent: - For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Medical Issues • History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product • Brainstem death at screening • Current evidence of septic shock as defined by the Surviving Sepsis Campaign (Presence of acute organ dysfunction secondary to infection plus hypotension with systolic blood pressure 80 mg Prednisolone /d; > 300 mg hydrocortisone / d), cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks • BMI 35 • Pregnancy / lactation or intention to fall pregnant during the time course of the study • Women of childbearing potential who are not using adequate contraception General Issues • Participation in other interventional drug trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of orally inhaled AP301 on alveolar liquid clearance in ALI patients with the purpose to assess the treatment associated changes of extravascular lung water (EVLW) within 7 days of treatment.;Secondary Objective: To assess: • the treatment associated changes of oxygenation as measured by the PaO2 / FiO2 ratio until day 7 of therapy, • the ventilatory plateau pressure and other ventilation parameters (Tidal volume, positive endexpiratory pressure, PIP, FiO2, respiratory rate, mean airway pressure and peak airway pressure) until day 7 of therapy, • the Murray lung injury score (a composite variable that includes components of oxygenation, compliance, positive end-expiratory pressure, and the appearance of the chest radiograph), • the duration of stay at ICU in the first 28 days, • the duration of controlled ventilation period until extubation, • number of days free from ventilatory support [for > 48 h] in the first 28 days • the survival status at day 28, • the local and systemic safety and tolerability and to identify possible dose related adverse events. ;Primary end point(s): Primary Endpoint is EVWL (measured with PiCCO® technique) between day 0 and day 7 of treatment.;Timepoint(s) of evaluation of this end point: from baseline to day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Oxygenation index (PaO2 / FiO2 ratio) until day 7 of treatment • Ventilator plateau pressure until day 7 of treatment • Murray Lung Injury Score until day 7 of treatment • Ventilation parameters / lung function: tidal volume (Vt), positive endexpiratory pressure (PEEP), PIP, respiratory rate, FiO2 , meak airway pressure, peak airway pressure until day 7 of treatment • Duration of stay at ICU in the first 28 days • Duration of controlled ventilation period until extubation • Number of days free from ventilation support (for > 48 h) in the first 28 days • Survival status at day 28 • the local and systemic safety and tolerability and to identify possible dose related adverse events;Timepoint(s) of evaluation of this end point: baseline to day 7 respectively day 28 (+7) | — |
Countries
Austria
Outcome results
None listed