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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Delia Dorrian
+44 (0)7531 220103
ddorrian02@qub.ac.uk


Prof Danny McAuley
+44 (0)2890 976466
d.f.mcauley@qub.ac.uk


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Be Part of Research - Trial Details - Investigating potential treatments for human lung injury in healthy volunteers
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Investigating potential treatments for human lung injury in healthy volunteers

Recruiting

Open to: All Genders

Age: Adult

Belfast

Medical Conditions

Acute Respiratory Distress Syndrome (ARDS)

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.


ARDS is a very serious condition that affects people who are in the hospital's intensive care unit. It happens when someone has another illness like an infection in their body. In ARDS, the immune system, which usually helps protect our bodies, causes an exaggerated inflammatory response and harms the lungs instead. This causes the lungs to become damaged and filled with fluid making it hard to breathe and get enough oxygen. Inflammation is a normal process which occurs in response to illness or injury. Normally it allows immune cells to target specific areas, but when this is dysregulated it causes harm to normal tissue.
When someone gets ARDS, there's a 40% chance they could die from it. There isn't a specific medicine to treat ARDS. Severe COVID-19, which has some similarities to ARDS, responded to treatment with a drug called baricitinib, and we want to explore how it could be used to treat people with ARDS. To do this we want to test how the drug works in the lungs of healthy people.

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:

01 Oct 2024 01 Nov 2025

Some of the volunteers will get the baricitinib and others won't get any medicine. To see how the medicine affects the lungs, the volunteers will breathe in a special particle called lipopolysaccharide (LPS) which causes an inflammatory response which is similar to that which we see in ARDS but to a small degree and for a shorter period. The amount of LPS that we give is similar to that which people would be exposed to if they smoked 5 cigarettes.

We will do a test using a small camera called a bronchoscope. It's a thin tube with a camera at the end that goes into the lungs through the mouth. This lets the scientists look at the lungs and take samples. We will compare the responses in the lungs between the group that got the baricitinib medicine and the group that did not. By doing this, we hope to find out if baricitinib can help reduce the inflammatory response in the lungs of people with ARDS. If it works well, it could be used as a treatment for ARDS in the future.


Healthy non-smoking adults aged 18-45 years old

You can take part if:



You may not be able to take part if:


1. Age <18 years 2. Age >45 years 3. BMI >30 kg/m²4. On concomitant medications including over-the-counter medications excluding hormonal contraception and paracetamol 5. Previous adverse reactions to LPS, lignocaine or sedative agents6. Pregnant or breast-feeding 7. Participation in a clinical trial of an investigational medicinal product within 30 days 8. Consent declined9. History of asthma or other respiratory conditions 10. Smoking or e-cigarette use 11. Marijuana use or other inhaled products (with or without nicotine) in the last 3 months 12. Alcohol abuse, as defined by the Alcohol Use Disorders Identification Test (AUDIT) 13. Subjects with history of prior conventional cigarette (> 100 cigarettes lifetime and smoking within 6 months) or electronic cigarette use.14. Live vaccine with in preceeding 4 weeks15. Abnormal blood count, renal function or liver function tests identified at screening16. History of shingles17. History of Hepatitis B/C18. Allergy to Baricitinib


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

  • Mater Hospital
    45-54 Crumlin Rd
    Belfast
    BT14 6AB

Participants will be compensated for taking part in the study, but will otherwise not directly benefit from treatment administered. Outcomes from this study will however be used to help inform future clinical trials for patients who have acute respiratory distress syndrome.
Baricitinib is a reversible well tolerated JAK 1 and 2 inhibitor. It is commonly used in treating rheumatoid arthritis. Previous healthy volunteer studies have demonstrated that plasma concentration peaks within 1.5 hours post-dose and subsequently declines in a bi-exponential fashion, with minimal systemic accumulation over repeated dosing.
In healthy volunteer studies where baricitinib has been given for a short duration no serious infections or adverse effects were noted.
In chronic treatment studies in rheumatoid arthritis patients baricitinib has been associated with an increased risk of upper respiratory tract infection, increase in blood cholesterol count, abnormal liver blood tests, anaemia, low white cell counts, high platelets, risk of pneumonia, urinary tract infections and gastroenteritis. There is also a risk of reactivation of tuberculosis (TB), hepatitis B and C, and varicella zoster. This can occur in 1 in 100. Uncommon side effects with chronic use include risk of deep vein thrombosis, pulmonary embolism and diverticulitis (1 in 1000 risk). It has been associated with an increased risk of non-melanoma skin cancers in those receiving chronic treatment.
These adverse effects have not been demonstrated to occur in COVID-19 patients treated with baricitinib for up to 10 days.
Participants will be screened: for medical history, clinical examination and safety bloods to exclude those at increased risk of complications from participating in the study. Baricitinib is only being used for 3 days. This is to allow the drug to reach a steady state without prolonged exposure to the drug. Baricitinib is cleared with minimal systemic accumulation and is expected to be cleared within 48 hours of the last dose.
Inhaled LPS challenge is a safe healthy volunteer model of ARDS. The dose of LPS administered is equivalent to that obtained from 5-6 cigarettes. It causes a short-lived reaction which lasts for up to 24 hours and is associated with a mild flu-like illness which can be treated with paracetamol. This procedure will be carried out using a calibrated dosimeter by experienced staff in an appropriate clinical setting.
Bronchoscopy and broncho-alveolar lavage is a safe procedure which is carried out under conscious sedation and local anaesthetic. This procedure will be carried out in a suitable clinical area with experienced clinical staff under the supervision of an experienced respiratory physician. This procedure is normally well tolerated but some can experience a flu-like illness in the 24 hours post-procedure.

Prof Danny McAuley
+44 (0)2890 976466
d.f.mcauley@qub.ac.uk


Dr Delia Dorrian
+44 (0)7531 220103
ddorrian02@qub.ac.uk



The study is sponsored by Belfast Health and Social Care Trust and funded by Belfast Health and Social Care Trust, Belfast Trust Charitable Funds.



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Read full details for Trial ID: ISRCTN16086655
Last updated 18 November 2024

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