Chronic Obstructive Pulmonary DiseasePhase 3OPTINEBNCT03449056
High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A Phase 3 study testing salbutamol in people with Chronic Obstructive Pulmonary Disease and High-flow Nasal Cannula, run by Poitiers University Hospital at 1 site in France.
Trial summary
High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, High-flow Nasal Cannula
- What is being tested?
- salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2019to Apr 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arterial pH over 7.25,
- Respiratory rate under 35 breaths/mn
- Glasgow Coma Scale equal to 15,
- indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
- NIV sessions spaced more than 6 hours.
Who cannot join
- Urgent endotracheal intubation;
- Contraindication to beta 2 adrenergic agonist;
- Another organ failure (hemodynamic and neurological instability);
- Cardioselective beta-blocker during treatment of copd exacerbation;
Trial locations and contacts
1 site in 1 country.
nicolas MARJANOVIC contact
France1 site, 1 recruiting
- Recruiting
C.H.U. de Poitiers
Poitiers, 86000
Jean-Pierre Frat, MD, jean-pierre.frat@chu-poitiers.fr
About this study
High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.
- Being tested
- salbutamol
- 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.
salbutamolDrug
T2 - T1+1h30: High-nasal flow and salbutamol nebulization
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Experimental | salbutamol nebulization Receives: Drug: salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare lung functions
Evolution of Forced Expiratory Volume 1s
Measured: baseline-1h30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start11 Jan 2019
- Primary completionJan 2020 (estimated)
- Study completionApr 2020 (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.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449056
- Sponsor's protocol ID
- OPTINEB
- Acronym
- OPTINEB
- Status last verified
- Feb 2019
- First submitted
- 12 Jan 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Nebulization of Beta 2 Adrenergic Agonist During Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03449056
- Acronym / sponsor ID
- OPTINEB / OPTINEB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Feb 2018 (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.
High-flow nasal cannula is an oxygenation technique increasingly used for patients admitted for acute respiratory failure. Literature essentially concerns "de novo" acute hypoxemic failure and the interest of high-flow during take care of chronic obstructive pulmonary disease patients is few studied. Physiological studies reported potential benefits of high-flow nasal cannula oxygenation in chronic obstructive pulmonary disease patients including dead space clearance and decrease of respiratory, which lead to decrease work of breathing. As inhaled bronchodilators are part of treatment of chronic obstructive pulmonary disease exacerbation, nebulization could be also provided through high-flow nasal cannula oxygen therapy. The aim of our study is to determine whether a beta-2 agonist nebulization administered through High-flow nasal cannula is efficient to improve spirometry of patients for admitted hronic obstructive pulmonary disease exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Experimental | Drug: salbutamolsalbutamol nebulization |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Arterial pH over 7.25,
- Respiratory rate under 35 breaths/mn
- Glasgow Coma Scale equal to 15,
- indication of beta-2 agonist nebulization less than 8 per day (time between two nebulization more than 3 hours),
- NIV sessions spaced more than 6 hours.
Key exclusion criteria (4 listed)
- Urgent endotracheal intubation;
- Contraindication to beta 2 adrenergic agonist;
- Another organ failure (hemodynamic and neurological instability);
- Cardioselective beta-blocker during treatment of copd exacerbation;
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 |
|---|---|---|
| salbutamolT2 - T1+1h30: High-nasal flow and salbutamol nebulization | Drug | TREATMENT |
Primary outcome
compare lung functions
Time frame: baseline-1h30
Evolution of Forced Expiratory Volume 1s
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: No
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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.
nicolas MARJANOVIC contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing salbutamol in people with Chronic Obstructive Pulmonary Disease and High-flow Nasal Cannula, run by Poitiers University Hospital at 1 site 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 5 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 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre FRAT (+33549442830, jean-pierre.frat@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare lung functions (time frame: baseline-1h30). 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 12 Feb 2019.