AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Phase I/IIa (MORPHEUS I/IIa)

This research, called MORPHEUS I/IIa, is investigating if giving a small amount of the pain-relieving medicine Morphine can help people with a serious lung condition called Chronic Obstructive Pulmonary Disease (COPD). Specifically, it's for those who have a sudden worsening of their symptoms and need help with their breathing using a special machine called non-invasive ventilation. The study wants to find out if morphine can make this breathing support more effective and easier to tolerate, reducing the chance that the treatment might not work well. This is an early-stage study, combining Phase I (which largely checks for safety and the right dose) and Phase II (which starts to look at how well the treatment works). The goal is to see if this approach could be a helpful new way to manage severe COPD flare-ups.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

Start

07 Oct 2024

Chronic Obstructive Pulmonary Disease

What is this study about?

Imagine you have a long-term lung condition like COPD, where breathing can be very difficult. Sometimes, your breathing can suddenly get much worse, which doctors call an 'acute exacerbation'. When this happens, you might need help from a machine that supports your breathing through a mask, called 'non-invasive ventilation' (NIV).

While NIV is very helpful, sometimes it doesn't work as well as hoped, or it can be uncomfortable for patients. This study, named MORPHEUS I/IIa, is exploring if giving a very small, controlled dose of morphine – a medicine often used for pain relief – could make a difference. The idea is that morphine might help you feel more comfortable and breathe more easily while on the breathing support.

The main goal is to see if this small dose of morphine can help prevent the breathing support from failing in its early stages. This research is in its first stages (Phase I and II), meaning we're looking to understand if it's safe and if there are promising signs that it could be an effective treatment in the future. It’s an important step to find better ways to help people with severe COPD when they’re most unwell.

Key takeaways

Study explores if low-dose morphine helps severe COPD patients on breathing support.
Aims to make breathing support (NIV) more effective and comfortable.
Early stage research (Phase I/IIa) checking for safety and initial results.
Open to adults 18+ with acute COPD flare-ups needing NIV.
Participation involves receiving morphine or placebo, with close monitoring.

Who may be eligible?

This study is open to adults aged 18 and older. Both men and women can take part. To be considered, you would need to have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

Importantly, the study is for people who are currently experiencing a sudden and severe worsening of their COPD (an 'acute exacerbation') and require non-invasive ventilation (breathing support through a mask) to help them breathe.

There might be other specific health requirements or conditions that would mean you can or cannot join the study, which the research team would discuss with you in detail. These are in place to make sure the study safe for participants and that the results are clear.

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 18 years old or older?
Do you have a diagnosis of COPD?
Are you currently having a severe COPD exacerbation (flare-up)?
Do you need breathing support through a mask (non-invasive ventilation) right now?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given a small dose of morphine, or a dummy medicine (placebo), alongside your usual treatment for your COPD flare-up. The study will carefully monitor your breathing, how you feel, and any effects of the medicine. This will involve regular checks by doctors and nurses while you are receiving breathing support. The total duration of your participation would depend on how long you need the breathing support and the specific requirements for follow-up during your hospital stay.

Potential risks and benefits

Participating in research always has potential benefits and risks. You might benefit if the morphine helps your breathing support work better for you, potentially leading to a more comfortable and effective treatment for your COPD flare-up. However, there's no guarantee the treatment will help you personally. Potential risks of morphine may include drowsiness, nausea, or slower breathing, which the medical team would monitor very closely. Remember, you have the right 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.

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Unverified
France

Common questions

What is COPD?

COPD is a common lung disease that makes it hard to breathe. It includes conditions like emphysema and chronic bronchitis.

What is non-invasive ventilation (NIV)?

NIV is a way to help you breathe using a mask over your nose or face, connected to a machine. It pushes air into your lungs to make breathing easier.

What is morphine?

Morphine is a strong medicine often used to relieve severe pain. In this study, a very small dose is being explored for its potential effects on breathing.

Will I definitely get morphine?

No, you might receive morphine or a placebo (a dummy medicine with no active ingredients). This helps researchers see the true effect of morphine.

Is this a new treatment?

Morphine is an old medicine, but using it in this specific way, at these doses, for this purpose in COPD patients on NIV is what's being researched to see if it's safe and effective.