Chronic Obstructive Pulmonary DiseasePhase 3ECHO/ICUNCT01155310
Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Helium/Oxygen 78%/22% and Air/Oxygen in people with Chronic Obstructive Pulmonary Disease, run by Air Liquide Santé International at 16 sites in 6 countries.
Trial summary
The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Helium/Oxygen 78%/22% and Air/Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 16 sitesin 6 countries
- Study dates
- May 2010to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with known or suspected COPD
- Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure
- Patient eligible for Non-Invasive Ventilation (NIV)
- Patient admitted in an ICU
Who cannot join
- Patient who had lung transplant
- Patient having a contraindication to NIV
- Patient with tracheostomy
- Patient requiring Oxygen flow rate > 6 L/min or Inspired Oxygen Fraction (FIO2) > 0.50
- Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
France9 sites
Centre Hospitalier Universitaire Angers
Angers, 49933
Centre Hospitalier Universitaire Pellegrin-Tripode
Bordeaux, 33076
Hôpitaux de Chartes
Chartres, 28018
CHU Clermont-Ferrand - Hôpital ESTAING
Clermont-Ferrand, 63003
Hôpital Henri Mondor
Créteil, 94010
CHU NICE - Hopital Pasteur
Nice, 06002
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75908
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer - Hopital Sainte Musse
Toulon, 83056
Belgium2 sites
Cliniques Universitaires Saint Luc
Brussels, 1200
Les Cliniques Universitaires UCL Mont Godinne
Yvoir, 5530
Tunisia2 sites
Hôpital Abderrahmen Mami
Aryanah, 2080
Centre Hospitalier Universitaire Fattouma Bourguiba
Monastir, 5000
United Kingdom1 site
University Hospital of North Tees
Stockton-on-Tees, TS19 8 PE
About this study
Official title: An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.
The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.
Read the detailed description
Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.
During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.
Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Helium/Oxygen 78%/22%, Air/Oxygen
- Keywords
- Exacerbation of COPD, Helium/Oxygen, ICU, Non-Invasive Ventilation, Patient with known or suspected COPD, patient Admitted in an ICU, Patient presenting current exacerbation of COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helium/Oxygen 78%/22%Drug
The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.
Patients will then receive the Air/Oxygen mixture with usual devices.
Air/OxygenDrug
The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.
Patients will then receive the Air/Oxygen mixture with usual devices.
| Study group | Role | What they receive |
|---|---|---|
| Helium/Oxygen | Experimental | Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours. Receives: Drug: Helium/Oxygen 78%/22% |
| Air/Oxygen | Active comparator | Air/Oxygen will be administered for a maximum of 72 hours. Receives: Drug: Air/Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of NIV failure
Endotracheal intubation and/or death
Measured: 10 days (average)
Secondary outcomes (7)
Duration of ICU stay and duration of index hospitalisation
Measured: 10 days (average)
Duration of invasive ventilation
Measured: 10 days (average)
Adverse events
Measured: 6 months (post-randomization)
Medico-economic parameters
Overall costs and cost-effectiveness
Measured: 6 months
Physiological and laboratory parameters
Systolic and diastolic blood pressures, heart rate, central body temperature, arterial oxygen saturation, haematology and serum biochemistry
Measured: 10 days (average)
Duration of NIV sessions
Cumulative daily duration of NIV sessions and their number during each of the 3-day treatment period and globally
Measured: 10 days (average)
Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD
Measured: 6 months (post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2013
- Study completionJun 2014
Why it stopped: the observed event rate is lower than expected by the protocol hypothesis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe JOLLIET, Prof., Study chair, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155310
- Sponsor's protocol ID
- ALMED-07-C3-009
- Acronym
- ECHO/ICU
- Status last verified
- Oct 2014
- First submitted
- 25 Jun 2010
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC.
PubMed 27736154
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Phase III Randomised Trial Comparing in Severe Exacerbations of Chronic Obstructive Pulmonary Disease the Efficacy of Helium/Oxygen Versus Air/Oxygen Administered During Spontaneous Breathing and Intermittent Non-Invasive Ventilation.
- ClinicalTrials.gov ID
- NCT01155310
- Acronym / sponsor ID
- ECHO/ICU / ALMED-07-C3-009
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Exacerbation of COPD, Helium/Oxygen, ICU, Non-Invasive Ventilation, Patient with known or suspected COPD, patient Admitted in an ICU, Patient presenting current exacerbation of COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the observed event rate is lower than expected by the protocol hypothesis.
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.
Detailed description
Patients eligible for this study are critically ill patients with COPD admitted in Intensive Care Unit for an exacerbation of their chronic disease with hypercapnic acute respiratory failure. The patients will receive an Helium/Oxygen mixture or an Air/Oxygen mixture for a maximum of 72 hours during Non-Invasive Ventilation (NIV) and NIV-free sessions.
During NIV sessions, gas mixtures will be administered using a ventilator suitable for NIV with either He/O2 or Air/O2 and a NIV facemask.
Patients will be followed until hospital discharge and then contacted by phone up to the 6th month after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helium/Oxygen | Experimental | Drug: Helium/Oxygen 78%/22%Helium/Oxygen 78%/22% will be administered for a maximum of 72 hours. |
| Air/Oxygen | Active comparator | Drug: Air/OxygenAir/Oxygen will be administered for a maximum of 72 hours. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with known or suspected COPD
- Patient presenting current exacerbation of COPD with hypercapnic acute respiratory failure
- Patient eligible for Non-Invasive Ventilation (NIV)
- Patient admitted in an ICU
Key exclusion criteria (5 listed)
- Patient who had lung transplant
- Patient having a contraindication to NIV
- Patient with tracheostomy
- Patient requiring Oxygen flow rate > 6 L/min or Inspired Oxygen Fraction (FIO2) > 0.50
- Patient admitted in the ICU for more than 24 hours and/or having received NIV in ICU for more than 6 hours (in total) for the current exacerbation of COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helium/Oxygen 78%/22%The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices. Patients will then receive the Air/Oxygen mixture with usual devices. | Drug | Helium/Oxygen |
| Air/OxygenThe Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices. Patients will then receive the Air/Oxygen mixture with usual devices. | Drug | Air/Oxygen |
Primary outcome
Reduction of NIV failure
Time frame: 10 days (average)
Endotracheal intubation and/or death
7 secondary outcomes
Duration of ICU stay and duration of index hospitalisation
Time frame: 10 days (average)
Duration of invasive ventilation
Time frame: 10 days (average)
Adverse events
Time frame: 6 months (post-randomization)
Medico-economic parameters
Time frame: 6 months
Physiological and laboratory parameters
Time frame: 10 days (average)
Duration of NIV sessions
Time frame: 10 days (average)
Time interval between the discharge of the index ICU stay and the first re-admission in ICU for severe exacerbation of COPD
Time frame: 6 months (post-randomization)
Results and safety
The study was stopped early (reason given: the observed event rate is lower than expected by the protocol hypothesis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Derived from this study: PubMed 27736154Jolliet P, Ouanes-Besbes L, Abroug F, Ben Khelil J, Besbes M, Garnero A, Arnal JM, Daviaud F, Chiche JD, Lortat-Jacob B, Diehl JL, Lerolle N, Mercat A, Razazi K, Brun-Buisson C, Durand-Zaleski I, Texereau J, Brochard L; E.C.H.O. ICU Trial Investigators. A Multicenter Randomized Trial Assessing the Efficacy of Helium/Oxygen in Severe Exacerbations of Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2017 Apr 1;195(7):871-880. doi: 10.1164/rccm.201601-0083OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe JOLLIET, Prof. study chair
Centre Hospitalier Universitaire Vaudois
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Helium/Oxygen 78%/22% and Air/Oxygen in people with Chronic Obstructive Pulmonary Disease, run by Air Liquide Santé International at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France, Belgium, Tunisia, Italy, Switzerland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the observed event rate is lower than expected by the protocol hypothesis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of NIV failure (time frame: 10 days (average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.