All studies
Active not recruitingPHASE4INTERVENTIONAL

REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study

This study, called REIMAGINE, is designed to understand how a medicine named mepolizumab (also known as NUCALA) helps adult patients with severe asthma. Specifically, it's looking at whether using this medicine helps people reach 'clinical remission' – a state where their asthma is very well controlled with fewer symptoms and flare-ups. It's a 'real-world' study, meaning doctors are observing patients who are already taking NUCALA as part of their regular care. They're interested in how timely treatment affects severe asthma, especially for those whose asthma involves a certain type of inflammation often called 'eosinophilic'. The study aims to gather information from many different hospitals globally.

At a glance

Status
Active not recruiting
Phase
PHASE4
Sponsor
GlaxoSmithKline
Enrolment target
336
Start
20 Mar 2024
Estimated completion
14 Jun 2028

What is this study about?

Imagine your asthma becoming so well-controlled that you hardly notice it, with very few symptoms and flare-ups. This is sometimes called 'clinical remission', and it's what the REIMAGINE study hopes to learn more about for people with severe asthma.

This study is looking at a specific medicine called mepolizumab (brand name NUCALA). This medicine is prescribed for people with severe asthma, especially those who have a type of inflammation involving certain white blood cells (doctors might call this 'eosinophilic asthma'). The researchers want to see how starting NUCALA at the right time helps adult patients achieve this better level of asthma control.

Unlike traditional drug trials that test new medicines, this is a "real-world" study. This means it observes people who are already being treated with NUCALA by their doctors in their everyday lives. The aim is to gather practical information from many different hospitals worldwide to understand how well NUCALA works in a typical healthcare setting.

Key takeaways

  • The REIMAGINE study looks at how NUCALA helps adults with severe asthma.
  • It aims to see if NUCALA can lead to 'clinical remission' – better asthma control.
  • This is a 'real-world' study observing patients already taking NUCALA.
  • It focuses on a type of severe asthma linked to 'eosinophilic' inflammation.
  • Participation involves monitoring your treatment and progress with NUCALA.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has been officially diagnosed with asthma. Importantly, your doctor must have already decided to treat your severe asthma with NUCALA, or you might have started it very recently (within 7 days of joining).

You shouldn't have used NUCALA or similar asthma medicines (like omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab) in the six months before starting the study. Also, your breathing tests should show a certain lung function (FEV1 of 60% or more), and you should not have experienced more than four severe asthma flare-ups in the past year. You also can't be taking certain daily steroid tablets.

Your doctor will also make sure that joining the study won't be difficult for you, for example, if there are concerns about sticking to the treatment plan. Each person will need to give their written permission to take part.

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.

  1. Are you 18 years old or older?
  2. Has your doctor diagnosed you with asthma?
  3. Has your doctor prescribed NUCALA for your asthma (or you started it very recently)?
  4. Have you *not* used NUCALA or similar biologic asthma medicines in the last 6 months?
  5. Do you have certain lung function and not too many flare-ups in the last year, as confirmed by your doctor?
  6. Are you *not* taking certain daily steroid tablets?
Answer every question to see your result.

What does participation involve?

If you join the REIMAGINE study, you would already be taking NUCALA for your asthma, as prescribed by your doctor. The study will involve your doctor collecting information about your asthma, your treatment with NUCALA, and how you are responding to it. This would include your breathing test results (like spirometry), your asthma symptoms, and any flare-ups you experience.

As this is a 'real-world' study, it largely involves documenting your regular care and treatment with NUCALA. You would continue to see your doctor for your usual asthma appointments. The length of time you would be followed in the study isn't specified, but it would involve monitoring your progress with NUCALA over time. You would not receive any new treatments that aren't already part of your normal care plan.

Potential risks and benefits

Taking part in this study means your doctors will closely monitor your condition and the effects of NUCALA, which might give you and your doctor a deeper understanding of your asthma. As NUCALA is already an approved medicine, the main risks are those generally associated with its use, which your doctor should discuss with you. There are no new or experimental treatments involved. You are free to withdraw from the study at any time without affecting your medical care.

Locations (65)

  • GSK Investigational Site
    Verified postcode
    La Jolla, United States
  • GSK Investigational Site
    Verified postcode
    Newport Beach, United States
  • GSK Investigational Site
    Verified postcode
    Aurora, United States
  • GSK Investigational Site
    Verified postcode
    Colorado Springs, United States
  • GSK Investigational Site
    Verified postcode
    New Haven, United States
  • GSK Investigational Site
    Verified postcode
    Homestead, United States
  • GSK Investigational Site
    Verified postcode
    Jacksonville, United States
  • GSK Investigational Site
    Verified postcode
    Miami, United States
  • GSK Investigational Site
    Verified postcode
    Plantation, United States
  • GSK Investigational Site
    Verified postcode
    Adairsville, United States
  • GSK Investigational Site
    Verified postcode
    Columbus, United States
  • GSK Investigational Site
    Verified postcode
    Lexington, United States

Common questions

What is NUCALA?

NUCALA is a medicine used to treat severe asthma, especially a type called 'eosinophilic asthma', which involves specific white blood cells.

What does 'clinical remission' mean for asthma?

It means your asthma is very well controlled, with few symptoms, flare-ups, and good lung function.

Is this a new medicine being tested?

No, NUCALA is an approved medicine. This study is observing how it works in real-life for people already taking it.

Will I have extra doctor visits if I join?

Possibly not. The study mainly collects information from your usual asthma appointments and treatment.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time, and it won't affect your medical care.

How to find out more

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

Discussion

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