RecruitingOBSERVATIONAL

Longitudinal Phenotyping and Endotyping Study in Adult Patients With Mild, Moderate, or Severe Asthma

This long-term study wants to learn more about how asthma varies among people and how it changes over time. Researchers will observe asthma's effects on the body by looking at different causes of flare-ups, symptoms, and how airway inflammation might affect breathing over the years. The information collected will help improve understanding of asthma progression. Participants will be adults aged 18 and over who have an asthma diagnosis and attend hVIVO clinics. The study involves a baseline visit, annual clinic visits for about five years, and some home assessments, including when cold-like symptoms occur. There are no direct health benefits, but participants will receive health checks.

At a glance

Status

Recruiting

Sponsor

Hvivo

Enrolment target

250

Start

08 Aug 2025

Estimated completion

08 Aug 2050

Asthma (Diagnosis)

What is this study about?

This research study, called MAPLE, is designed to help us understand why asthma affects people so differently and how it might change over many years. When you have asthma, it's not the same for everyone – some people have mild symptoms, others have more severe issues, and triggers for flare-ups can vary. This study wants to explore these differences.

The researchers will be looking closely at how asthma affects the body, including what causes or triggers asthma flare-ups, the specific symptoms people experience, and how inflammation in the airways might impact breathing health over time. By gathering this detailed information from many people, they hope to get a clearer picture of how asthma progresses and why some people's asthma gets worse or better, and how different treatments might affect this.

Ultimately, the goal is to use this knowledge to better understand asthma. This deeper understanding could one day lead to better ways to manage the condition, and help tailor care more effectively for individuals living with asthma in the future. It’s about building a better overall picture of asthma for everyone.

Key takeaways

This study helps understand how asthma affects people differently over time.
It involves annual clinic visits and home assessments for about five years.
You must be an adult (18+) with an asthma diagnosis and attend hVIVO clinics.
Participation will not directly improve your health, but you'll get health checks.
There are some minor risks associated with medical tests, but trained staff will be present.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with asthma. You'll need to be someone who attends the hVIVO respiratory clinics. Your asthma diagnosis must be confirmed by specific tests, such as a positive response to a methacholine challenge test (which checks how sensitive your airways are), a positive response to an inhaler that opens your airways, or if your breathing measurements (peak flow) show significant changes during the day. A doctor's diagnosis of current asthma also counts.

However, some people won't be able to join. For example, if your main breathing problem isn't asthma, even if you have other lung conditions like COPD, you won't be suitable. Women who are pregnant or breastfeeding cannot take part. You also won't be able to join if you have certain health conditions that make lung function tests unsafe, like recent bleeding from your lungs, a history of collapsed lung, severe heart problems, or recent eye or abdominal surgery. People with a history of severe allergic reactions or anaphylaxis are also typically excluded. The researchers also need to be confident that you'll be able to attend visits and complete the study over its planned duration.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of asthma?
Do you attend hVIVO respiratory clinics?
Are you not currently pregnant or breastfeeding?
Do you feel you would be able to attend appointments for approximately five years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, the study will begin with a screening visit to check if you're suitable and to assess your asthma. After this, you'll have about five annual clinic visits over a period of roughly five years. There will also be phone calls in between if needed. You'll be asked to do some simple self-assessments at home halfway between each annual clinic visit. Should you get cold-like symptoms, you'll be asked to take a nasal and throat swab at home and keep a diary of your symptoms, medicines, and lung function.

During clinic visits, you might have various tests and checks, including lung function tests and discussions about your inhaler technique. One specific test you might have, only if it's safe for you, is called a methacholine challenge, which helps assess how sensitive your airways are. The study is designed to run for at least five years for each participant.

Potential risks and benefits

Taking part in this study won't directly improve your health or treat your asthma, but you'll receive general health checks and assessments of your inhaler technique during the study. There are some potential risks with the tests involved. Drawing blood can cause pain or bruising. Nasal samples might cause discomfort, sneezing, watery eyes, an irritated nose, or nosebleeds. Lung function tests can sometimes lead to light-headedness, dizziness, fatigue, coughing, shortness of breath, headaches, chest discomfort, or an irritated throat. Skin prick tests might cause skin irritation or allergic reactions. A methacholine challenge test is likely to cause temporary asthma symptoms like wheezing, shortness of breath, and chest tightness, and in very rare cases, it could cause severe breathing problems, though staff are trained to manage this. Any abnormalities found during the study will be shared with you and, if necessary, your GP or a specialist. You are free to withdraw from the study at any time.

Locations (1)

hVIVO Services Limited, 40 Bank Street
London, United Kingdom· Recruiting

Common questions

What is the main goal of this study?

The main goal is to understand how asthma varies between individuals and how it changes over time, including what causes flare-ups and how airway inflammation affects breathing.

Will my health improve if I join?

No, taking part in this study is not expected to improve your health, but you will receive general health checks and inhaler technique assessments.

How long will I be involved in the study?

You'll be involved for about five years, with annual clinic visits and some home assessments in between.

What happens if I get cold-like symptoms during the study?

You'll be asked to take a self-nasal and throat swab at home and keep a diary of your symptoms, medication, and lung function.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point without giving a reason.

How to find out more

Alex Mann

projectadmin@hvivo.com +44 (0)207 756 1300 Official trial record

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