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

Study acronym: MORPHEUS I/IIa
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Notable Primary completion date: Jun 2026 to Jun 8, 2027
    • Study completion date: Jan 2027 to Jan 2028
    v7
  2. Notable Primary completion date: Jun 2024 to Jun 2026
    • Study completion date: Jul 2024 to Jan 2027
    v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Primary completion date: Jan 2022 to Jun 2024v4 Show 4 more changesShow less
    • Study completion date: Sep 2022 to Jul 2024
    • Eligibility criteria expanded, about 37 words
    • Site contact updated
    • Publications: 13 to 14
  5. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jan 2021 to Jan 2022
    • Start date changed from estimate of Jul 2020 to Dec 8, 2020
    • Study completion date: Sep 2021 to Sep 2022
    • Site details revised
  6. Minor Study description shortened, about 12 wordsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04427826
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)
Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov