RecruitingNAINTERVENTIONAL

Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)

This study aims to understand how our lungs react to infections, especially in people with asthma. Viruses can cause serious illness, and how our immune system responds is key. Researchers are using a safe, sterile substance called Resiquimod (R848) as a fine mist that participants will gently breathe in. This substance acts like a virus to trigger a mild, temporary reaction in the lungs, without actually causing an infection. The study builds on previous work using R848 as a nasal spray, which was found to be safe and well-tolerated. By collecting blood and phlegm samples, researchers hope to gain a better understanding of lung inflammation. This knowledge could lead to new treatments for lung conditions and viral infections. The study is open to both healthy volunteers and people with mild-to-moderate asthma aged 18-60.

At a glance

Status

Recruiting

Phase

Sponsor

Akhilesh Jha

Enrolment target

Start

24 May 2024

Estimated completion

01 Jul 2025

Innate Immunity Mucosal Immunity Asthma Viral Infection

What is this study about?

When we get a respiratory infection, like a cold or flu, our immune system gets to work. Sometimes, especially in people with conditions like asthma, this immune response can be too strong or not strong enough, leading to ongoing inflammation and worsening symptoms. Understanding exactly how our bodies react at the very beginning of an infection is crucial for creating better ways to treat lung problems and fight off viruses.

Studying real infections can be tricky and sometimes make people very unwell or require them to stay isolated. That's why this study uses a special, safe substance called Resiquimod (R848). Think of it like a pretend virus that triggers a similar immune response but without making you sick. Researchers have already used this as a nasal spray, which safely created a mild, short-lived 'cold-like' reaction. Now, they want to see how it affects the lungs directly.

In this study, participants will gently breathe in a tiny mist containing R848. This will allow researchers to see how the lungs respond to this 'viral mimic'. By carefully collecting samples of blood and phlegm afterwards, they can learn more about how inflammation starts and how different people's bodies react. This knowledge is important because it can help scientists develop new and more effective treatments for conditions that cause lung inflammation, like asthma, and for serious viral infections.

Key takeaways

Study examines lung immune responses to a safe viral mimic (Resiquimod R848).
Aims to understand lung inflammation in both healthy individuals and those with asthma.
Could lead to new treatments for respiratory infections and lung conditions.
Involves inhaling a fine mist and providing blood and phlegm samples.
Participation is voluntary, and health will be closely monitored.

Who may be eligible?

This study is looking for both healthy adults and adults with mild-to-moderate asthma. You need to be between 18 and 60 years old and able to understand and agree to take part. If you or your partner could become pregnant, you'll need to use effective birth control during the study.

If you have asthma, it needs to be well-controlled, not making you feel very unwell. You might be taking certain asthma medicines already, which is usually fine. You'll also need to show that your airways are slightly sensitive, which is common in people with asthma.

There are also reasons why you might not be able to join. For example, if you've recently had a chest or upper chest infection, if you are pregnant or breastfeeding, if you have other serious health problems, or if your doctor thinks it wouldn't be safe for you. You also need to be able to produce a phlegm sample. You will have some simple health checks like blood tests and an ECG (heart trace) to make sure you're suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 60 years old?
Do you understand what the study involves and are you willing to take part?
If you or your partner could become pregnant, are you willing to use effective contraception?
Can you provide a phlegm sample when asked?
Have you been free from any respiratory infections for at least the past 2-4 weeks?
If you have asthma, is it mild-to-moderate and well-controlled?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll undergo some initial health checks, including blood tests, an ECG, and checks on your lung function. You'll then attend a session where you'll gently breathe in a small amount of the test substance (Resiquimod/R848) through a mouthpiece. After this, researchers will collect blood and phlegm samples to see how your body has reacted. You might have to attend follow-up visits to ensure your body has returned to its normal state and that there are no lasting effects. The full duration of your participation will be explained in detail by the study team, but it will involve several visits to the clinic.

Potential risks and benefits

Potential benefits of participating include contributing to important medical research that could lead to better treatments for lung inflammation and respiratory infections. You'll also receive health checks. Potential risks are generally mild, as the substance used is designed to cause only a temporary, mild reaction similar to a cold, and has been used safely before. You might experience some temporary mild cold-like symptoms. Any procedures, like blood draws, carry small risks such as bruising. You will be closely monitored by the study team. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NIHR Cambridge Clinical Research Facility
Verified postcode
Cambridge, United Kingdom· Recruiting

Common questions

What is Resiquimod (R848)?

It's a sterile, harmless substance that acts like a virus to trigger a mild, temporary reaction in your immune system, but it can't actually infect you.

Will I get sick from this study?

No, the substance used is not a real virus and cannot cause an infection. It's designed to create a brief, mild, cold-like response safely.

Why are blood and phlegm samples needed?

These samples help researchers understand how your body, particularly your lungs, responds to the 'viral mimic' at a cellular level.

Who can take part?

The study is open to healthy adults and those with well-controlled mild-to-moderate asthma, aged 18 to 60. Specific health checks will confirm if you're suitable.

What's the main goal of the study?

To better understand lung inflammation and immune responses to develop more effective treatments for respiratory infections and conditions like asthma.

How to find out more

Akhilesh Jha, MBBS; MRCP; PhD

cuh.lungchallenge@nhs.net +44 01223254642 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.