Chronic Obstructive Pulmonary DiseaseAirvoNEBNCT02812979
Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified
A study testing Airvo2 with Aerogen Solo and Mask in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Tours at 1 site in France.
Trial summary
The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Airvo2 with Aerogen Solo and Mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 27 Apr 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- Patient with chronic obstructive pulmonary disease
- Patients, when performing lung function tests performed outside of the study :
- A report FEV / FVC less than 60% prior to bronchodilator treatment AND
- A positive reversal test defined by FEV variation of over 12 % and 200 mL after administration of inhaled salbutamol
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Who cannot join
- Exacerbation of chronic obstructive pulmonary disease during
- Uncontrolled asthma
- Pneumothorax current or recent ( < 2 months)
- Pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h
- hemoptysis in progress
- Patient under guardianship or trusteeship safeguard justice
- Pregnant or breastfeeding women or parturient woman
- Known allergy or intolerance to salbutamol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
The principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).
Read the detailed description
Randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Airvo2 with Aerogen Solo, Mask, arm control Airvo2 without nebulization of 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.
Airvo2 with Aerogen SoloDevice
Also called AirvoNEB
Nebulization of salbutamol with Airvo 2 and Aerogen solo
MaskDevice
Usual nebulization of salbutamol with mask
arm control Airvo2 without nebulization of salbutamolDevice
Airvo2 with Aerogen Solo. No nebulization of salbutamol
| Study group | Role | What they receive |
|---|---|---|
| Airvo2 with Aerogen Solo | Experimental | AIRVOTM2 will be set to deliver air (21% oxygen concentration ) at a rate of 30 L / min at 100 % relative humidity at 37 ° C.
Nebulization of salbutamol will be effected by means of a nebulizer to the vibrating screen (Aerogen® Solo, Aerogen , Galway, Ireland ) which is a nebulizing device for single use, commonly used in invasive and non invasive mechanical ventilation.
Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol Receives: Device: Airvo2 with Aerogen Solo |
| Mask | Active comparator | During nebulization in the usual way ( oral facial mask ) , it will be used a pneumatic nebulizer powered by a 6 L / min air flow rate ( usual method ).
Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol Receives: Device: Mask |
| arm control Airvo2 without nebulization of salbutamol | Placebo comparator | control procedure is to be placed under humidified high flow nasal alone Receives: Device: arm control Airvo2 without nebulization of salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased expiratory volume in one second ( FEV )
Measured: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol
Secondary outcomes (3)
clinical data (FVC) on the physiological effects of high nasal flow
Measured: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
clinical data (FEV) on the physiological effects of high nasal flow
Measured: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
clinical data (FEV / FVC) on the physiological effects of high nasal flow
Measured: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
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.
- More trials run by University Hospital, ToursThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812979
- Sponsor's protocol ID
- PHAO15-SE / AirvoNEB
- Other IDs
- 2016-A00064-47
- Acronym
- AirvoNEB
- Status last verified
- May 2018
- First submitted
- 16 Jun 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reminiac F, Vecellio L, Bodet-Contentin L, Gissot V, Le Pennec D, Salmon Gandonniere C, Cabrera M, Dequin PF, Plantier L, Ehrmann S. Nasal high-flow bronchodilator nebulization: a randomized cross-over study. Ann Intensive Care. 2018 Dec 20;8(1):128. doi: 10.1186/s13613-018-0473-8.
PubMed 30570679
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Nebulization Bronchodilators Under High Nasal Flow Humidified Compared to a Usual Method
- ClinicalTrials.gov ID
- NCT02812979
- Acronym / sponsor ID
- AirvoNEB / PHAO15-SE / AirvoNEB
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 24 Jun 2016 (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 principal objective is to show noninferiority of nebulized salbutamol through the high flow nasal system moistened AIRVO ™ 2 in terms of reversibility of airflow obstruction compared to nebulization by the usual method (spray mask).
Detailed description
Randomized, comparative, non inferiority study between two nebulization strategies bronchodilators, one according to the method tested namely the spray - in across the top humidified nasal flow system and the other according to a customary procedure, through a mask. A third arm will be evaluated (control arm) to overcome a possible own bronchodilator effect of high flow nasal humidified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Airvo2 with Aerogen Solo | Experimental | Device: Airvo2 with Aerogen SoloAIRVOTM2 will be set to deliver air (21% oxygen concentration ) at a rate of 30 L / min at 100 % relative humidity at 37 ° C. Nebulization of salbutamol will be effected by means of a nebulizer to the vibrating screen (Aerogen® Solo, Aerogen , Galway, Ireland ) which is a nebulizing device for single use, commonly used in invasive and non invasive mechanical ventilation. Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol |
| Mask | Active comparator | Device: MaskDuring nebulization in the usual way ( oral facial mask ) , it will be used a pneumatic nebulizer powered by a 6 L / min air flow rate ( usual method ). Nebulizer will be responsible for a salbutamol solution available in the form of containers of 2.5 ml containing 2.5 mg of salbutamol |
| arm control Airvo2 without nebulization of salbutamol | Placebo comparator | Device: arm control Airvo2 without nebulization of salbutamolcontrol procedure is to be placed under humidified high flow nasal alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults
- Patient with chronic obstructive pulmonary disease
- Patients, when performing lung function tests performed outside of the study :
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Key exclusion criteria (8 listed)
- Exacerbation of chronic obstructive pulmonary disease during
- Uncontrolled asthma
- Pneumothorax current or recent ( < 2 months)
- Pleural aspiration or biopsy , trans - bronchial biopsies and / or bronchoalveolar lavage in the preceding 48h
- hemoptysis in progress
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 |
|---|---|---|
| Airvo2 with Aerogen SoloAlso: AirvoNEBNebulization of salbutamol with Airvo 2 and Aerogen solo | Device | Airvo2 with Aerogen Solo |
| MaskUsual nebulization of salbutamol with mask | Device | Mask |
| arm control Airvo2 without nebulization of salbutamolAirvo2 with Aerogen Solo. No nebulization of salbutamol | Device | arm control Airvo2 without nebulization of salbutamol |
Primary outcome
Increased expiratory volume in one second ( FEV )
Time frame: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol
3 secondary outcomes
clinical data (FVC) on the physiological effects of high nasal flow
Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
clinical data (FEV) on the physiological effects of high nasal flow
Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
clinical data (FEV / FVC) on the physiological effects of high nasal flow
Time frame: before and after treatment with humidified high nasal flow at 0 minute and 30 minutes after the treatment with humidified high nasal flow
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 30570679Reminiac F, Vecellio L, Bodet-Contentin L, Gissot V, Le Pennec D, Salmon Gandonniere C, Cabrera M, Dequin PF, Plantier L, Ehrmann S. Nasal high-flow bronchodilator nebulization: a randomized cross-over study. Ann Intensive Care. 2018 Dec 20;8(1):128. doi: 10.1186/s13613-018-0473-8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo2 with Aerogen Solo and Mask in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Tours 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 22 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increased expiratory volume in one second ( FEV ) (time frame: measured before and after nebulization of salbutamol at 0 minute and 15 minutes after nebulization of salbutamol). 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 NCT02812979, 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 22 Dec 2025.