Acute respiratory distress syndrome (ARDS) MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: BAY 1097761 lyophilisate for inhalation
Product Code: BAY 1097761
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: N/A
CAS Number: 1432735-93-7
Current Sponsor cod
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years of age at the time of inclusion into study. 2. Invasively mechanically ventilated ARDS patients (diagnosed according to Berlin definition of ARDS, including PEEP of =5 cm H²O, X-ray (or CT scan) indicative of ARDS: bilateral opacities not fully explained by cardiac failure, fluid overload, lobar/lung collapse, effusions or nodules). 3. Initial diagnosis of mild, moderate or severe ARDS prior to study inclusion, with acute onset of ARDS within 1 week after suspected trigger factor of a. Pneumonia b. Aspiration c. Sepsis d. Pancreatitis 4. Prior to randomization, hypoxemia with PaO²:FiO² =300 mmHg continuously observed for a period of =4 hours (with values of =2 arterial blood gas [ABG] analyses during that time, with the last value obtained timely (generally =3 hours) prior to randomization), under ventilation with minimum PEEP =8 cm H²O. 5. Time from first meeting the last diagnostic ARDS criterion (Berlin criteria) to randomization must be =48 hours. 6. For Study Part A: ARDS patients for whom measurements of extra-vascular lung water are regarded as medically indicated by the treating physician, and these measurements are planned as part of their clinical care, from Study Day 1 up to Study Day 7 (if then still intubated). 7. Male and non-pregnant female 8. Informed consent of capable patient or, in case of patient being incapable of giving informed consent, consent for study inclusion will be sought according to applicable laws and regulations. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 166
Exclusion criteria
Exclusion criteria: 1. Any value of a PaO²:FiO² ratio >300 mmHg within a time interval of 4 hours before randomization 2. Rescue therapy (e.g. inhalation of nitric oxide gas and/or inhalation of prostacyclin analogues, or ECMO/ECCO2R) already initiated at screening and/or Study Day 1 (prior to first dose of the study intervention) 3. Moribund participants not expected to survive 24 hours (clinical decision) 4. Expected duration of invasive mechanical ventilation less than 48 hours (clinical decision) 5. History of co-morbidities requiring long-term/home oxygen use (e.g. severe chronic obstructive pulmonary disease [COPD], pulmonary fibrosis) or non-invasive ventilation (except for sleep apnea management), or making weaning per se improbable (e.g. ALS, muscular dystrophy) 6. Smoke inhalation injury, extensive burns or trauma/head injury as concomitant condition 7. History of pneumectomy, lung lobectomy or lung transplant 8. Diffuse alveolar hemorrhage from vasculitis 9. Current lung malignancy (incl. lung metastasis), or other malignancy requiring chemotherapy or radiation within the last month 10. Chronic kidney disease with a history of renal replacement therapy (e.g. dialysis) 11. Chronic liver disease Child-Pugh Class C 12. Chronic heart failure NYHA IV 13. Known hypersensitivity to polyethylenglycol (PEG, Macrogol) 14. Participation in other interventional studies involving pharmacological interventions, or biological or cell therapy interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and efficacy of inhaled PEG-ADM in ARDS;Secondary Objective: Not applicable;Primary end point(s): Part B only: Ventilator-free survival (VFS, proportion of participants alive and off invasive mechanical ventilation) at study day 28;Timepoint(s) of evaluation of this end point: At study day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A only: 1. Clinical Utility Index (CUI) based on data from the first week of treatment (change vs. baseline), CUI is derived from o Extravascular lung water index (EVLWi) o Oxygenation index (OI) o Non-pulmonary Sequential Organ Failure Assessment (npSOFA) score 2.Ventilator-free survival (VFS, proportion of participants alive and off invasive mechanical ventilation) at study day 28 Part A and Part B: 3. All-cause mortality at study day 28, study day 60 and study day 90 4. Proportion of participants who still require invasive mechanical ventilation support at study day 28 and study day 60 5. Ventilator-free days (VFDs) within study day 28 and study day 60 6. Ventilator-free survival at study day 60 7. Integrated analysis on Ventilator-free survival at study day 28 and study day 60, involving all participants from Part A and Part B;Timepoint(s) of evaluation of this end point: 1. during the first week of the study 2. at study day 28 3. at study day 28, study day 60 and study day 90 4 at study day 28 and study day 60 5. within study day 28 and study day 60 6. at study day 60 7. at study day 28 and study day 60 | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Portugal, Romania, Russian Federation, Slovakia, Switzerland, United Kingdom, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed