REVERT : REVErsing airway Remodelling with Tezepelumab : a protocol for a double blind randomized controlled trial for patients with asthma
People with severe asthma often experience ongoing swelling that causes the walls of their breathing tubes to become thick and stiff. This long-term change is known as airway remodelling, and it makes breathing harder over time. The REVERT study is investigating whether a biologic medicine called tezepelumab (Tezspire) can help reverse these structural changes. Adults aged 18 and over with severe asthma will take part. Participants will be randomly chosen to receive either tezepelumab injections or a dummy injection (placebo) alongside their regular asthma care. Over the course of 12 months, researchers will use detailed, low-dose chest CT scans to take pictures of the lungs. By comparing scans taken at the start, at six months, and at one year, doctors hope to see whether tezepelumab can make the airways wider and thinner, helping people breathe more easily.
At a glance
What is this study about?
Severe asthma is a long-term condition where the airways in the lungs become swollen, narrow, and sensitive. Over many years, frequent swelling can cause the walls of the breathing tubes to thicken and develop scar-like tissue. Doctors call this process 'airway remodelling'. Once airways become thick and stiff, standard inhalers may not work as well, leaving people with persistent breathlessness and frequent asthma flare-ups.
Tezepelumab (sold under the brand name Tezspire) is an injection that targets an early trigger of lung inflammation. While doctors already know it can reduce asthma attacks, this study looks specifically at whether it can actually heal and reverse structural airway damage. This could represent a major shift from simply managing symptoms to repairing the lungs.
The REVERT trial is a 'double-blind, randomised controlled trial'. This means half of the participants will receive the active medicine and half will receive an inactive dummy treatment (placebo). Neither the participants nor their study doctors will know who is receiving which injection during the trial. This ensures the results are completely fair and unbiased.
To check if the medicine is working, doctors will use specialised computed tomography (CT) scans to take 3D pictures of the lungs at the start, at 6 months, and at 12 months. Computer programs will measure the exact thickness and width of the airways. If successful, this research could give people with severe asthma new hope for protecting their lung health in the long run.
Key takeaways
- Tests whether tezepelumab can reverse airway thickening in severe asthma.
- Open to adults aged 18 and over with severe asthma.
- Uses detailed chest CT scans at baseline, 6 months, and 12 months to measure lung changes.
- Half of the participants receive the active medicine and half receive a dummy injection (placebo).
- Participation lasts approximately one year alongside your usual asthma care.
Who may be eligible?
This trial is open to men and women aged 18 and over who have been diagnosed with severe asthma that is difficult to control with regular inhalers alone.
Because this study focuses on reversing airway damage, participants will need to be able to safely undergo chest CT scans and perform standard breathing tests at the hospital clinic.
Your study doctor will review your full medical history, your current medicines, and your general health to ensure it is safe for you to take part. Women who are pregnant or breastfeeding may not be able to join.
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.
- I am aged 18 or older.
- I have been diagnosed with severe asthma.
- My asthma is not fully controlled despite using regular preventer treatments.
- I am able to attend regular hospital appointments for check-ups and injections.
- I am comfortable having chest CT scans and routine breathing tests.
What does participation involve?
Taking part in the study lasts for about 12 months. During this time, you will visit the hospital clinic regularly to receive an injection under the skin (either tezepelumab or a placebo) and check on your health.
You will have specialised chest CT scans taken at the start of the study, after 6 months, and after 12 months. These scans allow researchers to measure your airway walls in fine detail. You will also perform breathing tests (spirometry), answer questions about your asthma symptoms, and have standard health checks like blood pressure and blood tests.
You will continue taking your normal daily asthma medicines throughout the trial. Your study team will support you closely throughout the year.
Potential risks and benefits
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Common questions
What is airway remodelling?
Airway remodelling happens when long-term swelling makes the walls of your breathing tubes thicker and stiffer, which can make asthma symptoms harder to control.
Will I have to stop taking my regular asthma inhalers?
No. You will continue to use your prescribed asthma preventer and reliever medicines to keep your breathing safe and stable throughout the study.
What is a placebo?
A placebo is a harmless dummy treatment that looks identical to the real medicine but contains no active ingredients. It helps researchers prove whether the real drug works.
Does having a CT scan hurt?
No. A CT scan is completely painless. You will lie flat on a comfortable bed that moves through a doughnut-shaped scanner while holding your breath for a few seconds.
What happens if I change my mind during the trial?
You are free to leave the trial at any point, for any reason. Your decision will not change your relationship with your doctors or the standard of care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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