This study collects information on the safety of inhaled pegylated adrenomedullin (PEG-ADM), how the drug is tolerated and how it effects patients suffering from a type of lung failure that cause fluid to build up in the lungs making breathing difficult (ARDS)

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS); MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-001078-27-AT
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-21
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 466

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

Medical Conditions
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. Diagnosis of COVID-19 pneumonia within 6 weeks prior to study inclusion. History of SARS-CoV-2 infection (positive test based on nucleic acid amplification technology or positive antigen test) without COVID-19 pneumonia does not exclude patients (see also Section 8.2.6)
Prior/Concurrent Clinical Study Experience
15. Plan to participate or past participation (within 30 days prior to Study Day 1) in other interventional studies involving pharmacological interventions, or biological or cell therapy interventions.
Participation in other interventional studies that study modifications of supportive care regimens or similar objectives may be possible if the intervention in question would be regarded not to endanger outcome assessments or supportive care recommendations described in this protocol. Investigator and sponsor assess the implications of such a study; if no mutual agreement is reached, the patient is to be excluded.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified