CORTICOP_Comparison of corticosteroids versus placebo on duration of ventilatory support during severe acute exacerbations of COPD patients in the intensive care unit: a multicentre randomized controlled trial
Chronic obstructive pulmonary disease (COPD) is a long-term lung condition that makes it hard to breathe. Sometimes, a severe flare-up means a person needs care in an intensive care unit (ICU) and requires a machine to support their breathing. This trial, called CORTICOP, tests whether an anti-inflammatory steroid medicine called methylprednisolone helps these very unwell patients. Participants in the ICU will receive either the steroid injection or a harmless dummy salt-water injection (a placebo). Doctors want to find out if the steroid helps people come off breathing machines sooner and leave the ICU faster. They will also check for common side effects of steroids, such as high blood sugar or infections. Patients will be monitored closely during their hospital stay and contacted again at 90 days to see how their breathing and recovery are going.
At a glance
What is this study about?
Chronic obstructive pulmonary disease (COPD) affects the airways and lungs, causing breathlessness and coughing. People with COPD can sometimes have sudden, dangerous flare-ups. In severe cases, the lungs struggle so much that the person must go to an intensive care unit (ICU) to be connected to a breathing machine, such as a tight-fitting mask or a breathing tube.
Breathing machines save lives, but staying on them for too long can lead to complications like lung infections or weak muscles. Doctors often use steroid medicines to calm swelling in the airways, but they need clearer proof about whether high doses given by injection truly help ICU patients come off breathing machines faster.
This study compares an injected steroid called methylprednisolone against a dummy treatment (placebo). Half of the patients will get the steroid and half will get the placebo alongside their usual intensive care. By comparing the two groups, researchers hope to discover the safest and most effective way to help people with COPD recover from life-threatening breathing crises.
Key takeaways
- Tests whether steroid injections help severe COPD patients come off breathing machines sooner.
- Takes place entirely within the hospital intensive care unit (ICU).
- Half of the participants receive the steroid medicine, and half receive a dummy salt-water injection.
- Patients are monitored in the hospital and followed up for 90 days.
- Participation is voluntary and does not stop standard NHS intensive care.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with COPD and are currently being treated in an intensive care unit for a sudden, severe flare-up.
To be considered, patients must be unwell enough to need breathing support from a machine. This could be non-invasive support (like a specialised breathing mask) or invasive support (a tube placed into the windpipe).
Because this study takes place in the ICU when patients are critically ill, the hospital medical team will check medical records and current health conditions to decide if taking part is safe and appropriate.
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.
- I am (or my relative is) aged 18 or older.
- I have a known diagnosis of COPD.
- I am currently admitted to an intensive care unit (ICU).
- I am currently using a machine or mask to support my breathing.
- My ICU team believes it is safe for me to take part.
What does participation involve?
If you or your family member take part, the trial begins while in the intensive care unit. A computer will randomly choose whether the patient receives the steroid injection (methylprednisolone) or a dummy salt-water injection. Neither the patient nor the bedside doctors will know which treatment is given.
During the ICU stay, doctors will carry out normal intensive care checks. They will closely track blood sugar levels, blood pressure, muscle strength, and how many days breathing support is needed. Once home, there will be a final check-in around day 90 to ask about breathing comfort, quality of life, and any new hospital visits. The total study period is 90 days.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What medicine is being tested in this study?
The study tests methylprednisolone, which is an anti-inflammatory steroid given by an injection into a vein or muscle.
What is a placebo?
A placebo is a dummy treatment. In this trial, it is a simple salt-water injection that looks just like the real medicine but contains no active drug.
How is it decided who gets the real medicine?
A computer assigns participants by chance, like flipping a coin. You have an equal chance of receiving either the steroid or the placebo.
What if the patient is too unwell to give consent?
Because patients in intensive care may be unconscious or on strong sedatives, doctors will speak with a family member or legal representative first, in line with UK clinical trial laws.
Will taking part change standard intensive care treatment?
No. All patients will continue to receive full, standard intensive care, including oxygen, breathing support, antibiotics, and other essential medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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