Phase 2 COPD Trial, Recruiting NCT04427826 Sponsor: University Hospital, Grenoble Condition: COPD
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Phase 2 COPD Trial, Recruiting

NCT04427826
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who currently smoke or used to smoke, with a smoking history of at least 10 pack-years (a measure of how much someone has smoked over their lifetime)
  • People who have been diagnosed with COPD (a lung condition) based on recognised medical guidelines, as confirmed by their treating doctor
  • People currently experiencing a sudden worsening of their COPD symptoms that is worse than their usual day-to-day variation and requires a change in their treatment
  • People who need a type of breathing support called non-invasive ventilation (NIV), due to their blood becoming too acidic (a specific blood test result below a certain level)
  • People breathing faster than 20 breaths per minute
  • People who are covered by the French social security system or an equivalent scheme
  • People who have given written agreement to take part, or whose legal representative has done so — if a person cannot consent on arrival, an emergency enrolment process is available, with consent required to be confirmed later

Who may not be able to join:

  • People who have already started receiving NIV before or during admission, or where NIV was started more than one hour before the point of enrolment
  • People who have taken sedative medications (such as sleeping tablets, benzodiazepines, or similar drugs) or morphine in the 24 hours before enrolment
  • People with a long-term alcohol dependency problem
  • People for whom NIV is medically unsuitable — this includes certain levels of reduced consciousness; a need for immediate breathing tube insertion; risk of inhaling stomach contents; inability to clear mucus; unstable blood pressure or heart function; inability to remove the breathing mask; facial injuries, surgery, or structural differences affecting the face. People with a blood acidity level below a certain threshold may only be enrolled if they are in an intensive care unit or specific emergency care setting with continuous monitoring (confirm with trial site)
  • People receiving NIV purely for end-of-life comfort care, where death is expected within 24 hours of enrolment
  • People who are unable to communicate or who have significant memory or cognitive impairment that would prevent participation in the study
  • People for whom morphine is medically unsuitable, where there is no acute breathing emergency present
  • People who are pregnant or breastfeeding
  • People who fall under specific categories protected under French public health law (Articles L1121-6 and L1121-8) (confirm with trial site)
  • People who are currently participating in another clinical research study of a certain type (Type 1 or Type 2 under French regulations)
  • People who cannot be contacted in an emergency

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Damien VIGLINO, MD, PhD, Grenoble Alpes University Hospital, HP2 laboratory - INSERM U1042 and Grenoble Alpes University

Phone: 0033476766784

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
8 December 2020
Est. completion
8 June 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

The probability of dose - limiting toxicity (DTL), defined as the occurrence of one or more of the following criteria occurring within 4 hours of morphine administration; Efficacy and toxicity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov