RecruitingOBSERVATIONAL

Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting

This study aims to understand how prednisolone, a widely used anti-inflammatory medicine, behaves in your body, particularly when taken at higher doses or for longer periods. We want to see if the amount of prednisolone in your blood stays the same, even if you’re taking the same dose. This is important because while prednisolone is very effective for conditions like thyroid eye disease, vasculitis, asthma, or COPD, it can also have side effects. By understanding how your body processes this medicine, especially over time or when changing doses, doctors might be able to prescribe it more effectively, potentially reducing side effects and improving treatment for your condition.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

120

Start

12 Apr 2023

Estimated completion

31 Dec 2030

Thyroid Eye Disease Vasculitis COPD Exacerbation Acute Asthma Inflammatory Disease

What is this study about?

This study is designed to understand how your body uses and processes a common anti-inflammatory medicine called prednisolone. Prednisolone is a type of steroid widely used to calm down inflammation and overactive immune responses in many different health conditions, such as severe asthma, thyroid eye disease, and certain inflammatory conditions affecting blood vessels (vasculitis).

While prednisolone is very effective, especially at higher doses, it can sometimes cause unwanted side effects. Doctors always try to use the lowest effective dose for the shortest time needed to manage your condition. This study is exploring if the amount of prednisolone in your bloodstream is consistent, both when you first start taking it and if you've been on it for a while. We're also looking at whether changing from other similar medicines (like methylprednisolone or dexamethasone) affects how your body handles prednisolone. Understanding these processes better could help doctors tailor your prednisolone dose more precisely in the future, aiming to get the best results while keeping side effects to a minimum. Ultimately, this research hopes to provide information that leads to more personalised and safer prednisolone treatments.

We're particularly interested in patients who are on higher doses of prednisolone, either for a short period during a flare-up or for longer-term management. We're also studying those who are transitioning between different steroid medicines. By looking at these different groups, we hope to gain a clearer picture of how prednisolone is processed in various situations.

Key takeaways

Understanding how your body processes a common steroid called prednisolone.
Aims to help doctors prescribe prednisolone more effectively in the future, potentially reducing side effects.
Involves taking blood samples at specific times while you're on your usual prednisolone treatment.
Focuses on patients taking higher doses of prednisolone or changing between similar steroid medicines.
Participation will not change your existing medical treatment.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged between 18 and 75, both men and women, who are generally healthy enough to participate. You would need to be able and willing to understand and sign a consent form to join the study.

Specifically, we're looking for different groups of people. This includes those who are starting a high dose (at least 30mg) of prednisolone for an inflammatory condition for the first time, either in hospital or as an outpatient. We're also looking for people who have been taking a high dose (over 30mg) of prednisolone for at least a month, and those who are starting a course of high dose methylprednisolone or dexamethasone, which are similar steroid medicines.

However, you wouldn't be able to join if you have Type 1 or Type 2 diabetes. Also, if you're taking certain herbal supplements (like St John's Wort) or specific medications that can affect how prednisolone works (like phenytoin, rifampicin, or itraconazole), and you can't or won't stop them for the study, you wouldn't be eligible. Pregnant women cannot participate, and women of child-bearing age would need to provide a urine sample for a pregnancy test at each visit. Lastly, if you have any other medical or psychological condition, or are taking any other medicines that the study doctors feel would interfere with your safety or the study results, you would also not be able 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.

Are you between 18 and 75 years old?
Are you generally healthy enough to participate?
Do you currently require or are you on a high dose of oral prednisolone (at least 30mg)?
Have you been on a high dose of prednisolone for at least a month, or are you starting methylprednisolone/dexamethasone?
Do you NOT have Type 1 or Type 2 diabetes?
Are you able and willing to temporarily stop certain interacting medications or herbal supplements if required?

Answer every question to see your result.

What does participation involve?

As part of this study, you won't be given any new medicines; instead, we'll be studying how your body handles the prednisolone you're already taking as part of your usual care. To do this, we'll need to take blood samples at specific times during your treatment. The frequency and number of blood samples will depend on which group you are in (e.g., whether you're starting prednisolone, have been on it long-term, or are changing from another steroid). These samples will help us measure the levels of prednisolone in your blood. We'll also collect some additional samples to understand any other changes in your body.

There may also be follow-up appointments to collect further samples and review your progress. The total duration of your participation will vary depending on your specific treatment plan, but it's important to remember that this study is observing how your body responds to your usual clinical care, not changing it.

Potential risks and benefits

Participating in this study might not directly benefit you, but the information we gather will be incredibly valuable. It could help doctors in the future to prescribe prednisolone more effectively, potentially leading to better outcomes and fewer side effects for patients with inflammatory conditions. The main risks involve discomfort or bruising from blood draws, as is common with any blood sampling. There's also a small chance of infection, though this is minimised by standard sterile procedures. You would not be taking any experimental drugs, as this study observes your routine treatment. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is prednisolone?

Prednisolone is a type of steroid medicine that's widely used to reduce inflammation and calm down an overactive immune system in various medical conditions.

Why is this study being done?

We want to better understand how your body handles prednisolone, especially at higher doses or over time, to help doctors give more effective and safer treatments in the future.

Will I be given any new medicine?

No, you will not be given any new medicine. We are simply studying how your body reacts to the prednisolone you're already taking as part of your usual care.

What will I have to do if I take part?

You'll primarily need to provide blood samples at various times during your prednisolone treatment. The exact schedule will be explained to you in detail.

Can I stop participating if I change my mind?

Yes, you are completely free to withdraw from the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Katharine Lazarus, MBChB MRCP

imperial.steroids@nhs.net 07555717544 Official trial record

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