NCT04417036

This Study Collects Information on the Safety of Inhaled Pegylated Adrenomedullin (PEG-ADM), How the Drug is Tolerated and How it Affects Patients Suffering From a Type of Lung Failure That Cause Fluid to Build up in the Lungs Making Breathing Difficult (ARDS)

Safety and Efficacy of Inhaled Pegylated Adrenomedullin (PEG-ADM) in Patients Suffering From Acute Respiratory Distress Syndrome (ARDS): a Double-blind, Randomized, Placebo-controlled, Multicenter Phase 2a/b Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is composed of two parts. In part A of the study two active doses of inhaled pegylated adrenomedullin (PEG-ADM) will be compared regarding safety and efficacy to a substance that has no therapeutic effect (placebo) in order to find an optimal and safe of the study drug. In part B of the study the highest dose that is considered safe and has demonstrated efficacy will be taken forward to collect information how well patients suffering from Acute Respiratory Distress Syndrome (ARDS) respond to treatment with inhaled pegylated adrenomedullin (PEG-ADM) compared to treatment with placebo. ARDS is a type of lung failure that cause fluid to build up in the lungs making breathing difficult or impossible.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	BAY1097761 Active Dose 1	Participants will receive a lower dose ADM by inhalation
OTHER	Placebo to BAY1097761	Participants will receive Placebo to BAY1097761 by inhalation
DRUG	BAY1097761 Active Dose 2	Participants will receive a higher dose ADM by inhalation

Timeline

• Start date: 2020-07-07
• Primary completion: 2022-12-28
• Completion: 2022-12-28
• First posted: 2020-06-04
• Last updated: 2023-04-18

Locations

22 sites across 7 countries: Austria, Czechia, France, Germany, Italy, Spain, United Kingdom