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Tests treatment safety and results for Chronic Obstructive Pulmonary Disease
Official title Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Phase I/IIa
ClinicalTrials.gov ID: NCT04427826
What this study is testing
What is Morphine hydrochloride?
Morphine hydrochloride is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for chronic obstructive pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a major source of morbidity and mortality for patients and cost to the society. In case of acute respiratory failure with hypercapnia and acidosis, Non Invasive Ventilation (NIV) is preferred as a first line treatment.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Need to implement NIV treatment (respiratory acidosis with pH\<7.35)
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, Isère, Auvergne-Rhône-Alpes, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, Isère, Auvergne-Rhône-Alpes, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.