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Active not recruitingPHASE3INTERVENTIONAL

Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

This study is for people aged 12 to 80 with severe asthma. It wants to find out if a treatment called tezepelumab can help them keep their asthma under control, even if they start using less of their usual asthma inhalers. Doctors will see if tezepelumab helps people manage their asthma so well that they might be able to reduce other daily asthma medicines. The study will last up to 72 weeks, and participants will receive tezepelumab injections. The aim is to understand if this new treatment can lead to better long-term asthma control and even a period where symptoms are barely noticeable.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
326
Start
30 Sep 2024
Estimated completion
25 Jun 2027

What is this study about?

Severe asthma can be really tough to manage, often needing strong medicines to control symptoms. This study is looking at a new treatment called tezepelumab, which is given as an injection under the skin. The main idea is to see if people who take tezepelumab can reduce their daily asthma inhaler medications (like your regular preventer inhaler) without their asthma getting worse. For many people with severe asthma, reducing the amount of medicine they need while staying well would be a big step forward.

The researchers want to find out if tezepelumab not only helps control asthma but also allows people to achieve what doctors call 'clinical remission.' This means a period where your asthma symptoms are very low or almost gone, and you feel generally much better. If this study shows good results, it could mean a new way to manage severe asthma that makes life easier for many people.

This is a 'Phase 3b' study, which means the treatment has already been tested and shown some promise. Now, doctors want to understand more about how it works in real-world situations, specifically its ability to help people use less of their usual preventer inhalers while staying healthy.

Key takeaways

  • New study for severe asthma, looking at a treatment called tezepelumab.
  • Aims to see if patients can reduce other asthma medicines safely.
  • For people aged 12-80 with severe, diagnosed asthma.
  • Involves regular clinic visits over a period of up to 72 weeks.
  • Could help achieve better long-term asthma control.

Who may be eligible?

This study is looking for people aged between 12 and 80 years old who have severe asthma. To be considered, your asthma needs to have been diagnosed by a doctor within the last 10 years, and you should have been taking high-dose preventer inhalers (like a combination of an inhaled steroid and a long-acting bronchodilator) consistently for at least 6 months.

Doctors will also check your lung function. You'll need to show certain measurements, like your FEV1 (a measure of how much air you can forcefully breathe out in one second) is above a certain level, and that it improves after taking a bronchodilator. This helps them understand how your lungs react to medication and how severe your asthma is.

There are also some criteria about your asthma control and other medical conditions. The study team will review your full medical history to make sure taking part is safe and appropriate for you.

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 between 12 and 80 years old?
  2. Do you have severe asthma that was diagnosed by a doctor within the last 10 years?
  3. Have you been taking high-dose preventer inhalers for at least 6 months?
  4. Do you have medical records of your asthma history?
  5. Are you able to attend clinic visits once every four weeks?
Answer every question to see your result.

What does participation involve?

If you join this study, it will last for up to 72 weeks, which is about a year and three quarters. The actual treatment with tezepelumab will go on for up to 68 weeks. You'll need to visit the study clinic once every four weeks for check-ups and to receive your tezepelumab injection. At these visits, doctors will monitor your asthma symptoms, measure your lung function, and check for any side effects. You'll also likely have blood tests and answer questionnaires about your asthma. The study is divided into different stages, where doctors will gradually assess your asthma control and potentially guide you on reducing your background asthma medication, all while ensuring your safety and well-being.

Potential risks and benefits

Taking part in a study like this might offer the benefit of receiving a new treatment that could improve your asthma control and potentially reduce your need for other daily medications. However, like all medicines, tezepelumab could have side effects, and some people may not respond to the treatment. There's also the chance that reducing your regular asthma medication might make your asthma symptoms worse, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (70)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Palmdale, United States
  • Research Site
    Verified postcode
    Colorado Springs, United States
  • Research Site
    Verified postcode
    Miami, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    St Louis, United States
  • Research Site
    Verified postcode
    New Brunswick, United States
  • Research Site
    Verified postcode
    Oklahoma City, United States
  • Research Site
    Verified postcode
    McAllen, United States
  • Research Site
    Verified postcode
    Berazategui, Argentina
  • Research Site
    Unverified
    CABA, Argentina
  • Research Site
    Verified postcode
    Concepción del Uruguay, Argentina
  • Research Site
    Verified postcode
    Mendoza, Argentina

Common questions

What is tezepelumab?

Tezepelumab is a new medicine for severe asthma, given as an injection, that aims to help improve asthma control.

How often will I need to visit the clinic?

You will need to visit the clinic once every four weeks for check-ups and your treatment.

Can I stop my regular asthma inhalers if I join this study?

The study will explore if you can reduce your regular inhalers, but this will be carefully managed by the study doctors, not something you do on your own.

How long does the study last?

The entire study can last for up to 72 weeks (about a year and a half).

Will I know if I'm getting the new medicine?

This is an 'open-label' study, which means both you and your study doctor will know you are receiving tezepelumab.

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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