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Be Part of Research - Trial Details - 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)
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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)

Stopped

Open to: ALL

Age: 18.0 - N/A

Cardiff London

Medical Conditions

Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2020 Dec 2022

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Participants will receive a lower dose ADM by inhalation

Intervention Arm Group : Part A - Active Drug Dose 1;Part B - Active Drug Dose;

Intervention Type : OTHER
Intervention Description : Participants will receive Placebo to BAY1097761 by inhalation

Intervention Arm Group : Part A - Placebo;Part B - Placebo;

Intervention Type : DRUG
Intervention Description : Participants will receive a higher dose ADM by inhalation

Intervention Arm Group : Part A - Active Drug Dose 2;Part B - Active Drug Dose;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital of Wales
    Cardiff
    CF14 4XW
  • Guy'S Hospital
    London
    SE1 9RT


The study is sponsored by Bayer



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Read full details for Trial ID: NCT04417036
Last updated 13 April 2023

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