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

Who is this study for? Patients with Chronic Obstructive Pulmonary Disease
What treatments are being studied? Morphine Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Emergency Department of Grenoble Alpes University Hospital
RECRUITING
Grenoble
Contact Information
Primary
Damien VIGLINO, MD, PhD
DViglino@chu-grenoble.fr
0033476766784
Backup
Prudence MABIALA MAKELE, PhD
PMabialamakele@chu-grenoble.fr
0033476766784
Time Frame
Start Date: 2020-12-08
Estimated Completion Date: 2027-01
Participants
Target number of participants: 24
Treatments
Experimental: Patient admitted for acute Exacerbation of Chronic Obstructive
Patient admitted for acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) and required NIV
Sponsors
Leads: University Hospital, Grenoble

This content was sourced from clinicaltrials.gov