SEAL Trial
Research type
Research Study
Full title
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
IRAS ID
1003856
Contact name
Kaweh Shakery
Contact email
Sponsor organisation
Bayer AG
Eudract number
2019-001078-27
Clinicaltrials.gov Identifier
Research 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.
Summary of study results:
https://clinicaltrials.bayer.com/study/19999/
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0486
Date of REC Opinion
16 Aug 2021
REC opinion
Further Information Favourable Opinion