Actively Recruiting
Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Phase I/IIa
Led by University Hospital, Grenoble · Updated on 2026-04-15
24
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Current or former smokers with at least 10 pack-years
- Diagnosis of COPD according to Gold guidelines reviewed by the physician
- Experiencing an acute exacerbation of COPD requiring treatment change
- Need for Non Invasive Ventilation due to respiratory acidosis (pH <7.35)
- Respiratory rate greater than 20 breaths per minute
- Affiliated with the French social security system or equivalent
- Provided written informed consent or have surrogate consent if unable to consent at admission
You will not qualify if you...
- Already on Non Invasive Ventilation started more than one hour ago or before hospital admission
- Use of sedatives (barbiturates, benzodiazepines, related substances) or morphine within 24 hours before inclusion
- Chronic alcoholism
- Contraindications to NIV such as reduced consciousness (Glasgow <11), immediate need for intubation, risk of inhalation, inability to clear sputum, hemodynamic instability, inability to remove the mask, trauma or facial malformation
- Patients with pH below 7.25 only included in intensive care or emergency under continuous monitoring
- NIV started for palliative care with expected death within 24 hours
- Non-communicative or severe dementia preventing study participation
- Contraindication to morphine without acute respiratory distress
- Pregnant or breastfeeding women
- Minors as defined by French public health code
- Participation in other human research exclusion periods
- Unable to be contacted in an emergency
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Trial Site Locations
Total: 1 location
1
Emergency Department of Grenoble Alpes University Hospital
Grenoble, Isère, Auvergne-Rhône-Alpes, France, 38043
Actively Recruiting
Research Team
D
Damien VIGLINO, MD, PhD
CONTACT
P
Prudence MABIALA MAKELE, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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