NCT04427826 Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Phase I/IIa
| NCT ID | NCT04427826 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Hospital, Grenoble |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2020-12-08 |
| Primary Completion | 2027-06-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2020-12-08 with a primary completion date of 2027-06-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. NIV failures are not uncommon, from 15% in intensive care to 25 - 30% in emergency departments. They most often occur at the start of the NIV or in the hours that follow. There are many reasons for these failure. Among these are; dyspnea, discomfort, the pain related to the exacerbation and also to the NIV are frequently noted. The use of certain drugs with anxiolytic, hypnotic and/or analgesic properties could also be useful. Some sedatives and opioids have already been studied in this indication but without a therapeutic trial and satisfactory methodology. Among the molecules of interest, Morphine seems interesting . It's administration could reduce the ventilatory rate, intensity of dyspnea, pain and anxiety as well as dynamic hyperinflation. The investigators believe that morphine administration will decrease the rate of early NIV failure by improving comfort (decreased dyspnea and pain) and ventilation (decreased respiratory rate and increase in tidal volume) in patients with exacerbations of COPD. However, before considering a randomized phase III efficacy study, it is necessary to determine the optimal dose of morphine in this indication, through a phase I/II dose-finding study taking into accounts both the efficacy and toxicity of morphine. The main objective of this study, is to determine the optimal dose of morphine administered at the initiation of NIV in patient with acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), which is defined as the maximum gain function combining the probability of dose-limiting toxicity with PaCO2.Therefore, the impact of morphine administration on the physiological parameters of NIV- COPD exacerbation patients will be assessed.
Eligibility Criteria
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
Contact & Investigator
Damien VIGLINO, MD, PhD
PRINCIPAL INVESTIGATOR
Grenoble Alpes University Hospital, HP2 laboratory - INSERM U1042 and Grenoble Alpes University
Frequently Asked Questions
Who can join the NCT04427826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04427826 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04427826 currently recruiting?
Yes, NCT04427826 is actively recruiting participants. Contact the research team at DViglino@chu-grenoble.fr for enrollment information.
Where is the NCT04427826 trial being conducted?
This trial is being conducted at Grenoble, France.
Who is sponsoring the NCT04427826 clinical trial?
NCT04427826 is sponsored by University Hospital, Grenoble. The principal investigator is Damien VIGLINO, MD, PhD at Grenoble Alpes University Hospital, HP2 laboratory - INSERM U1042 and Grenoble Alpes University. The trial plans to enroll 24 participants.