Chronic Respiratory FailurePhase 2BANNISTERNCT01958814
Beta Agonist Nebulization in Non Invasively Ventilated COPD Patients: Safety, and Therapeutic Efficacy Range.
A Phase 2 study testing Salbutamol in people with Chronic Respiratory Failure, run by University Hospital, Tours at 3 sites in France.
Trial summary
randomized double-blind controlled study in parallel groups Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study. During this administration, non invasive ventilation for the patient will be continued. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2012to Jul 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Patient with BPCO, defined:
- by an irreversible obstructive syndrome
- and\or by different arguments (histories, symptoms, physical examination, thoracic radiography, gas of the blood)
- Decompensation of this BPCO in the form of acute respiratory failure
- No argument for a dominant acute left cardiac insufficiency
- Consent signed by the patient
- Patient with national health assurance
Who cannot join
- Contraindications in the not invasive ventilation
- Patient not volunteer for the realization of the spirometry
- Precautions for use of ß2 mimetic (engrave hyperthyroidism)
- Under guardianship patient or protection of justice
- Pregnant patient
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Réanimation Médicale - CHR d'Orléans
Orléans, 45000
Service de Réanimation
Poitiers, 86000
CHRU de Tours
Tours, 37000
About this study
Official title: Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation
randomized double-blind controlled study in parallel groups
Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.
During this administration, non invasive ventilation for the patient will be continued.
Read the detailed description
Randomization will focus on the treatment administered (placebo or salbutamol ).
After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .
- Conditions
- Chronic Respiratory Failure
- Being tested
- Salbutamol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called Treatment
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
PlaceboDrug
Also called physiological serum
First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol - Placebo | Experimental | salbutamol at M0 and M60 placebo administration Receives: Drug: Salbutamol; Drug: Placebo |
| Placebo - Salbutamol | Experimental | placebo at M0 and M60 salbutamol administration Receives: Drug: Salbutamol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection at the bedside spirometric values
Measured: gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start
Secondary outcomes (3)
gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow
Measured: between the median baseline and 15 min after the start of treatment
gross change in respiratory rate, heart rate and systolic and diastolic blood pressure
Measured: between baseline and 15 min after the start of treatment
gross change in dyspnea
Measured: between baseline and 15 min after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2015
- Study completionJul 2015
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 Respiratory FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-François DEQUIN, MD-PhD, Principal investigator, CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958814
- Sponsor's protocol ID
- PHAO11-PD / BANNISTER
- Other IDs
- 2011-004802-20
- Acronym
- BANNISTER
- Status last verified
- May 2016
- First submitted
- 7 Oct 2013
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.
PubMed 30589607
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
- Controlled Randomized Double-blind Study Comparing Salbutamol and Placebo Via Aerosol in Chronic Obstructive Respiratory Insufficiency in Exacerbartion Treated With Noninvasive Ventilation
- ClinicalTrials.gov ID
- NCT01958814
- Acronym / sponsor ID
- BANNISTER / PHAO11-PD / BANNISTER
- Conditions
- Chronic Respiratory Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Oct 2013 (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.
randomized double-blind controlled study in parallel groups
Salbutamol is a β2 mimetic short-acting to be administered by nebulization in this study.
During this administration, non invasive ventilation for the patient will be continued.
Detailed description
Randomization will focus on the treatment administered (placebo or salbutamol ).
After the first phase , a switch will be set up for each patient , retaining the blind it will be administered salbutamol (for those who received placebo in the first phase ) or placebo (for those receiving salbutamol ) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol - Placebo | Experimental | Drug: Salbutamol, Drug: Placebosalbutamol at M0 and M60 placebo administration |
| Placebo - Salbutamol | Experimental | Drug: Salbutamol, Drug: Placeboplacebo at M0 and M60 salbutamol administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient over 18 years old
- Patient with BPCO, defined:
- Decompensation of this BPCO in the form of acute respiratory failure
- No argument for a dominant acute left cardiac insufficiency
- Consent signed by the patient
Key exclusion criteria (5 listed)
- Contraindications in the not invasive ventilation
- Patient not volunteer for the realization of the spirometry
- Precautions for use of ß2 mimetic (engrave hyperthyroidism)
- Under guardianship patient or protection of justice
- Pregnant patient
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 |
|---|---|---|
| SalbutamolAlso: TreatmentFirst administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes) | Drug | Placebo - Salbutamol, Salbutamol - Placebo |
| PlaceboAlso: physiological serumFirst administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes) | Drug | Placebo - Salbutamol, Salbutamol - Placebo |
Primary outcome
Collection at the bedside spirometric values
Time frame: gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start
3 secondary outcomes
gross change in vital capacity of peak expiratory flow rate, the ratio of FEV, forced expiratory flow
Time frame: between the median baseline and 15 min after the start of treatment
gross change in respiratory rate, heart rate and systolic and diastolic blood pressure
Time frame: between baseline and 15 min after the start of treatment
gross change in dyspnea
Time frame: between baseline and 15 min after the start of treatment
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 30589607Bodet-Contentin L, Guillon A, Boulain T, Frat JP, Garot D, Le Pennec D, Vecellio L, Ehrmann S, Giraudeau B, Tavernier E, Dequin PF. Salbutamol Nebulization During Noninvasive Ventilation in Exacerbated Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial. J Aerosol Med Pulm Drug Deliv. 2019 Jun;32(3):149-155. doi: 10.1089/jamp.2018.1484. Epub 2018 Dec 27.
- 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.
Pierre-François DEQUIN, MD-PhD principal investigator
CHRU de TOURS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Salbutamol in people with Chronic Respiratory Failure, run by University Hospital, Tours at 3 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 8 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: 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 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Collection at the bedside spirometric values (time frame: gross change in forced expiratory volume in one second from the beginning of salbutamol or placebo and 15 min after the start). 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 NCT01958814, 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.