Chronic Obstructive Pulmonary DiseaseNIVOLDNCT03221101
Home Non Invasive Ventilation for COPD Patients
A study testing Home ventilator in people with Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure
- What is being tested?
- Home ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2011to Dec 2025
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients who survived after an acute episode of hypercapnic respiratory failure
- patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg
Who cannot join
- severe obstructive sleep apnea ( DI > 30/h)
- Non COPD cause of respiratory failure
- Serious comorbidity
- Adverse psychological status
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CH Dieppe
Dieppe
Pierre Louis Declercq, MD
- Recruiting
CH Elbeuf
Elbeuf
Mahdi Ould, MD
- Recruiting
Le Havre, Jacques Monod Hospital
Montivilliers, 76290
Clement Medrinal, +33664615110, medrinal.clement.mk@gmail.com
- Recruiting
CHU de Rouen
Rouen, 76000
Bouchra Lamia, MD, MPH, PhD, 02 32 88 90 84 ext. 0033, bouchra.lamia@chu-rouen.fr
Bouchra Lamia, MD, MPH, PhD
About this study
Official title: Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.
- Being tested
- Home ventilator
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ventilatorDevice
| Study group | Role | What they receive |
|---|---|---|
| Long Term Oxygen Therapy alone | No intervention | Long Term oxygen therapy is prescribed according to the guidelines |
| Non invasive ventilation | Active comparator | Home non invasive ventilation is prescribed with the following settings
* PS mode
* IPAP according to clinical and hemodynamic tolerance
* EPAP according to air trapping
* RR around 12/ min.
* LOT for SaO2 > 90%
* Monitoring with capnometry for settings validation Receives: Device: Home ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute hypercapnic respiratory failure episode
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
Measured: up to 24 months
Secondary outcomes (8)
acute hypercapnic respiratory failure episode rate
Measured: up to 24 months
pulmonary function test
Measured: at one month and every six months up to 24 months
Six Minute Walk Distance
Measured: at one month and every six months up to 24 months
Quality of life
Measured: at one month and every six months up to 24 months
Heart function
left and right heart function assessed using echocardiography
Measured: at one month and every six months up to 24 months
Cost effectiveness
Measured: at one month and every six months up to 24 months
mortality
Measured: at one month and every six months up to 24 months
arterial blood gas
Measured: at one month and every six months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- ADIR Association
- Responsible party
- Principal investigator, BOUCHRA LAMIA, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221101
- Sponsor's protocol ID
- 2013-AO1276-39 2010/080/HP
- Other IDs
- CPP-SC 010/2013
- Acronym
- NIVOLD
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Non Invasive Ventilation Versus Long Term Oxygen Therapy Alone in COPD Survivors After Acute Hypercapnic Respiratory Failure. A French Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03221101
- Acronym / sponsor ID
- NIVOLD / 2013-AO1276-39 2010/080/HP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- ADIR Association
- Study start
- Dec 2011 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jul 2017 (actual)
- 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.
Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. The purpose of this study is to determine whether home non invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an acute hypercapnic respiratory failure episode treated by non invasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Term Oxygen Therapy alone | No intervention | –Long Term oxygen therapy is prescribed according to the guidelines |
| Non invasive ventilation | Active comparator | Device: Home ventilatorHome non invasive ventilation is prescribed with the following settings * PS mode * IPAP according to clinical and hemodynamic tolerance * EPAP according to air trapping * RR around 12/ min. * LOT for SaO2 > 90% * Monitoring with capnometry for settings validation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD patients who survived after an acute episode of hypercapnic respiratory failure
- patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH > 7.35 and PCO2 > = 45 mmHg
Key exclusion criteria (4 listed)
- severe obstructive sleep apnea ( DI > 30/h)
- Non COPD cause of respiratory failure
- Serious comorbidity
- Adverse psychological status
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 |
|---|---|---|
| Home ventilator | Device | Non invasive ventilation |
Primary outcome
acute hypercapnic respiratory failure episode
Time frame: up to 24 months
first episode of acute hypercapnic respiratory failure episode requiring hospitalization
8 secondary outcomes
acute hypercapnic respiratory failure episode rate
Time frame: up to 24 months
pulmonary function test
Time frame: at one month and every six months up to 24 months
Six Minute Walk Distance
Time frame: at one month and every six months up to 24 months
Quality of life
Time frame: at one month and every six months up to 24 months
Heart function
Time frame: at one month and every six months up to 24 months
Cost effectiveness
Time frame: at one month and every six months up to 24 months
mortality
Time frame: at one month and every six months up to 24 months
arterial blood gas
Time frame: at one month and every six months up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
Related trials for Chronic Obstructive Pulmonary Disease
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home ventilator in people with Chronic Obstructive Pulmonary Disease and Hypercapnic Respiratory Failure, run by University Hospital, Rouen at 4 sites in France.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bouchra Lamia, MD, MPH, PhD (0685426884 ext. 33, bouchra.lamia@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute hypercapnic respiratory failure episode (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2017.