COPDRIONCT01192451
Prospective Cohort of Respiratory Insufficiency Outcome
An observational study of COPD and Non Invasive Ventilation, run by University Hospital, Grenoble at 4 sites in France.
Trial summary
The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COPD, Non Invasive Ventilation
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- Dec 2008to not given
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: COPD patients undergoing domiciliary noninvasive ventilation
Who may be able to join
- clinical diagnosis of COPD
- domiciliary noninvasive ventilation
Who cannot join
- noninvasive ventilation set up for a neuromuscular disease
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
University Hospital
Grenoble
JEAN FRANCOIS TIMSIT, PhD, 0476768779 ext. +33, JFTimsit@chu-grenoble.fr
JEAN LOUIS PEPIN, PhD
- Not yet recruiting
Hopital de La Croix Rousse
Lyon
PASCALE NESME MEYER, MD
- Not yet recruiting
Hopital de La Pitie Salpetriere
Paris
THOMAS SIMILOWSKI, PhD
JESUS GONZALEZ BERMEJO, MD
- Not yet recruiting
Hopital Nord
Saint-Etienne
ISABELLE COURT FORTUNE, MD
About this study
Official title: Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation
The Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.
- Conditions
- COPD, Non Invasive Ventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startDec 2008
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 COPDStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192451
- Sponsor's protocol ID
- 08SC01
- Acronym
- RIO
- Status last verified
- Sep 2010
- First submitted
- 30 Aug 2010
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
PubMed 24912564
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Domiciliary Noninvasive Positive Pressure Ventilation
- ClinicalTrials.gov ID
- NCT01192451
- Acronym / sponsor ID
- RIO / 08SC01
- Conditions
- COPD, Non Invasive Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2008
- First posted
- 1 Sep 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 Respiratory Insufficiency Outcome (RIO) project consists in a french multicenter prospective cohort of patients with chronic obstructive pulmonary disease (COPD) undergoing domiciliary noninvasive positive pressure ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- COPD patients undergoing domiciliary noninvasive ventilation
Key inclusion criteria (2 listed)
- clinical diagnosis of COPD
- domiciliary noninvasive ventilation
Key exclusion criteria (1 listed)
- noninvasive ventilation set up for a neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2010.
- Derived from this study: PubMed 24912564Borel JC, Pepin JL, Pison C, Vesin A, Gonzalez-Bermejo J, Court-Fortune I, Timsit JF. Long-term adherence with non-invasive ventilation improves prognosis in obese COPD patients. Respirology. 2014 Aug;19(6):857-65. doi: 10.1111/resp.12327. Epub 2014 Jun 9.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Non Invasive Ventilation, run by University Hospital, Grenoble 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 1 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 13 Sep 2010. 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 JEAN FRANCOIS TIMSIT, PhD (0476768779 ext. +33, JFTimsit@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192451, 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 13 Sep 2010.