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Could a tiny dose of morphine prevent breathing mask failure in COPD emergencies?

NCT ID NCT04427826

Symptom relief Sponsor: University Hospital, Grenoble Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tests whether a single low dose of morphine can reduce the chance that COPD patients in respiratory distress will fail non-invasive ventilation (a breathing mask). The study will enroll 24 adults with a COPD flare-up who need a breathing mask. Researchers will give one morphine injection at one of four low doses to find the best balance of safety and effectiveness. The goal is to see if morphine eases discomfort and improves breathing, potentially lowering the 15-30% failure rate seen with mask ventilation alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
morphine
What this could lead to
If it works, this could point toward a way to make breathing support more comfortable and effective for COPD patients in the emergency room.
What could go wrong
This is a very early, small study with only 24 people, so results may not apply broadly. Morphine can slow breathing or cause sedation, which could be risky in these patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients Aged ≥ 18 years * Current or former smoker at least 10 packs-years * Patient with a history of COPD according to the Gold guidelines , after review of the medical record by the physician in charge * Acute exacerbation of COPD (greater degradation of respiratory symptoms than the usual daily variations and requiring a modification of therapeutic management) * Need to implement NIV treatment (respiratory acidosis with pH\<7.35) * Ventilation frequency \> 20min * Affiliation to the French security system (or equivalent) * Written informed consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent. Exclusion Criteria: * Patient already treated by NIV during admission (e. g. introduction in pre-hospital by SMUR) or started more than one hour ago in the department. * Sedative (barbiturates, benzodiazepines and related substances and other sedatives) or morphine treatment within 24 hours before inclusion * Chronic alcoholism * Contra-indication to NIV: disturbances of consciousness (Glasgow \< 11) except moderate hypercapnic encephalopathy; indication of immediate intubation; risk of inhalation; sputum impossible; hemodynamic instability; inability to remove the mask; trauma, surgery or facial malformation; patients with pH \< 7.25 can only be included in intensive care unit or in the vital emergency room of the emergency department, under continuous monitoring * NIV with palliative purpose from the outset with death expected within 24 hours of inclusion * Non-communicative patient or significant dementia making them unable to participate in the study * Contra-indication to morphine without acute respiratory distress * Pregnant or breastfeeding women * Major mentioned in Articles L1121-6 and 1121-8 of French public health cod * Patients in a period of exclusion from other research involving the human person type 1 or 2 * Subject cannot be contacted in case of emergency

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emergency Department of Grenoble Alpes University Hospital

    RECRUITING

    Grenoble, Isère, Auvergne-Rhône-Alpes, 38043, France

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