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A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF

This research is looking into a new treatment called anakinra for people with cystic fibrosis (CF) who are aged 12 years and older. The main goal is to find out if this medicine can improve how well the lungs work, specifically by an important measure called the lung clearance index (LCI). The study will also carefully check if the treatment is safe and if people can take it without too many problems. On top of that, researchers want to see if anakinra has any other positive effects on lung function and overall quality of life for those with CF. It's an important step to see if this new treatment could help manage CF.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Heidelberg University
Enrolment target
52
Start
01 Dec 2022
Estimated completion
01 Dec 2026
Cystic Fibrosis, 10011762

What is this study about?

Cystic fibrosis (CF) is a genetic condition that mainly affects the lungs, making them produce thick, sticky mucus that can cause serious breathing problems and infections. Researchers are constantly looking for new ways to help manage CF and improve the lives of those living with it. This particular study is investigating a medicine called anakinra.

The main purpose of this study is to see if anakinra can help improve lung function in people with CF, specifically by looking at something called the lung clearance index (LCI). LCI is a way doctors can measure how well air moves in and out of the lungs. If anakinra can improve this, it could mean better breathing for people with CF. The study will also be checking very carefully to make sure the medicine is safe and that participants don't experience too many side effects.

This is a 'Phase 2' study, which means it's an important early step in testing new medicines. It's designed to gather more information about how anakinra works, its best dose, and any potential benefits or risks, before it can be considered for wider use. By taking part, people could be contributing to new scientific understanding that may help others with CF in the future.

Key takeaways

  • This study is testing a new medicine, anakinra, for cystic fibrosis.
  • It aims to see if anakinra improves lung function and is safe for people with CF aged 12 and older.
  • Participants will receive the medicine as an injection and have regular health checks.
  • The study is helping doctors understand if this treatment could benefit people with CF in the future.
  • Your medical information and well-being will be carefully monitored throughout the study.

Who may be eligible?

To join this study, you must be diagnosed with cystic fibrosis. Initially, the study is for adults aged 18 and older. However, if early results are promising, younger individuals aged 12 to 17 might also be able to join later.

There are also some medical requirements. For example, your breathing should be at a certain level, and your blood tests for things like your blood count, liver, and clotting ability need to be within a healthy range. You would also need to be able to complete questionnaires in German, as the study is being conducted where German is the primary language.

Some conditions might prevent you from joining. For instance, if you have certain infections, or if there have been recent changes to your other CF medications, you might not be suitable at this time. Women who could become pregnant would need to use effective birth control during the study.

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 or older, or possibly 12-17 if the study expands?
  2. Do you have a confirmed diagnosis of cystic fibrosis?
  3. Are your lungs working at a certain level (as measured by FEV1 and LCI tests)?
  4. Are your blood test results (for blood count, liver, clotting) within healthy limits?
  5. Can you understand and complete study materials in German?
  6. Are you able to use effective birth control if you are a woman who could become pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the study medicine, anakinra, as an injection under the skin. You will have regular visits to the clinic where the study team will carry out various checks. These will include tests similar to those you might already be familiar with, like breathing tests (including special ones for LCI and FEV1) to see how your lungs are working. They will also take blood samples to check your general health, make sure the medicine is safe, and measure its effects. You will also be asked to fill out questionnaires about your quality of life to see how you are feeling overall.

The total duration of your involvement in the study, including all treatments and follow-up, will be explained in detail by the study team. It will involve several weeks or months of regular appointments to monitor your health and the effects of the treatment. Any specific requirements for medication changes or other procedures will also be clearly laid out.

Potential risks and benefits

Participating in a clinical trial has potential benefits and risks. You might benefit from the study medicine, anakinra, if it improves your lung function or other aspects of your health related to CF. You would also be playing a key role in advancing medical knowledge that could help others with CF in the future. However, there's no guarantee the treatment will work for you, and you might experience side effects from the medicine, or discomfort from medical procedures like blood tests. The study team will explain all known potential risks in detail, and you will be closely monitored. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

  • University Children's Hospital Heidelberg, Cystic Fibrosis Centre
    Verified postcode
    Heidelberg, Germany· Recruiting
  • Universitätsmedizin Essen, Ruhrlandklinik
    Verified postcode
    Essen, Germany· Recruiting
  • Charité - Universitätsmedizin Berlin
    Verified postcode
    Berlin, Germany· Recruiting

Common questions

What is anakinra?

Anakinra is a medicine being tested in this study to see if it can help people with cystic fibrosis by improving their lung function and overall health.

Will I know if I'm getting the real medicine or a dummy treatment?

The study design will be explained by the research team; often in these types of studies, participants don't know if they are getting the active medicine or a placebo (inactive treatment) until the study ends. This helps ensure fair and unbiased results.

How long will I be in the study?

The exact duration of your participation, including how long you take the medicine and how many clinic visits you'll have, will be fully explained by the study team before you decide to join.

Do I need to speak German to participate?

Yes, to ensure you can understand study procedures and complete questionnaires, you or a legal guardian would need to be fluent in German.

What if I decide I don't want to continue in the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your ongoing medical care.

How to find out more

Official trial record

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

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate Safety and Efficacy of Subcutaneous Admi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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