COPD ExacerbationBRAVENCT04181073
Borg Score Outcomes in Respiratory Compromised Acute Exacerbating Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Treatment Via Vibrating Mesh Nebuliser Versus Jet Nebuliser in the Emergency Department
A study testing Jet Nebuliser and Vibrating Mesh Nebuliser in people with COPD Exacerbation and COPD, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare clinical outcomes in patients with acute COPD treated with a vibrating mesh nebuliser (VMN) versus a current standard jet nebuliser (JN), in the Emergency Department (ED). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD Exacerbation, COPD
- What is being tested?
- Jet Nebuliser and Vibrating Mesh Nebuliser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to Oct 2021
- 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
- • Primary presentation with acute exacerbation of COPD
Who cannot join
- • Unable to give valid consent
- Patient unable to speak English
- Patients where alternative diagnosis cannot be excluded
- Known or suspected pneumonia, pneumothorax, pneumomediastinum, pulmonary oedema, vocal cord dysfunction, aspirated foreign body
- Any contraindication to delivering bronchodilators
- Need for immediate intubation , ventilation or non-invasive ventilation
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- Pregnant or lactating
- Active palliation considered or expected mortality within 48 hours
- Known background/ comorbid respiratory disease associated with chronic or variable airflow obstruction (significant goitre, central lung tumour or other central airway pathology, bronchiectasis)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Emergency Department Queen Elizabeth University Hospital
Glasgow, Scotland, G51 4TF
David J Lowe, MBChB, 0141 232 7600, Glasgow.CRF@ggc.scot.nhs.uk
Claire McGroarty, MBChB
About this study
Official title: The BRAVE Study: Borg Score Outcomes in Respiratory Compromised Acute Exacerbating COPD Patients Receiving Treatment Via Vibrating Mesh Nebuliser Versus Jet Nebuliser in the Emergency Department
The purpose of this study is to compare clinical outcomes in patients with acute COPD treated with a vibrating mesh nebuliser (VMN) versus a current standard jet nebuliser (JN), in the Emergency Department (ED).
Participants will be those who meet the inclusion criteria and have a primary diagnosis of COPD, and consent to take part in the study. Operators will be clinical staff including doctors and nurses who will be trained in the use of the nebulisers.
Delivery of current treatment standards utilising a VMN compared to a JN will improve symptom scores in patients attending ED with COPD exacerbations.
Read the detailed description
This study is a prospective, single-centre, open, randomised study to improve management of acute COPD exacerbation within the Emergency Department. Adults with severe COPD are randomised into 2 groups: vibrating mesh nebuliser or standard jet nebuliser treatment. Salbutamol (5mg) and Ipratropium (0.5mg) will be administered via Aerogen Ultra via valved mask or a standard jet nebuliser via open face mask/. Two further doses of salbutamol to be delivered.
- Conditions
- COPD Exacerbation, COPD
- Being tested
- Jet Nebuliser, Vibrating Mesh Nebuliser
- Keywords
- nebulisation, vibrating mesh nebuliser
- 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.
Jet NebuliserDevice
Jet Nebuliser
Vibrating Mesh NebuliserDevice
Aerogen Device
| Study group | Role | What they receive |
|---|---|---|
| Jet Nebuliser | Active comparator | Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser Receives: Device: Jet Nebuliser |
| Vibrating Mesh Nebuliser | Experimental | Standard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser Receives: Device: Vibrating Mesh Nebuliser |
What is being measured
The primary outcome is the main question the study is designed to answer.
BORG Score
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)
Measured: 30 minutes post treatment
Secondary outcomes (5)
Oscillometry
Change of Oscillometry data
Measured: 30 minutes post treatment
Escalation of Care
Requirement for NIV (non invasive ventilation) / Intubation / further nebulisation
Measured: During Emergency Department Admission (typically < 4 hours)
Blood Gas
Change in blood gases post treatment
Measured: 30 minutes post treatment
Completion of Treatment
Time to complete initial nebulisation therapy in ED
Measured: During Emergency Department Admission (typically < 4 hours)
Staff Satisfaction
Reported ED staff satisfaction from main care giver post treatment. Likert 5 point scale. (0 highly dissatisfied 5 highly satisfied)
Measured: During Emergency Department Admission (typically < 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Jul 2019
- Primary completionJun 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Sequential
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Clyde and Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Aerogen
- Responsible party
- Principal investigator, David Lowe, NHS Greater Clyde and Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181073
- Sponsor's protocol ID
- GN17RM666
- Acronym
- BRAVE
- Status last verified
- May 2020
- First submitted
- 23 Nov 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be stored in Safe Haven GG\&C
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRAVE Study: Borg Score Outcomes in Respiratory Compromised Acute Exacerbating COPD Patients Receiving Treatment Via Vibrating Mesh Nebuliser Versus Jet Nebuliser in the Emergency Department
- ClinicalTrials.gov ID
- NCT04181073
- Acronym / sponsor ID
- BRAVE / GN17RM666
- Conditions
- COPD Exacerbation, COPD
- Keywords
- nebulisation, vibrating mesh nebuliser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NHS Greater Clyde and GlasgowUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 29 Nov 2019 (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.
The purpose of this study is to compare clinical outcomes in patients with acute COPD treated with a vibrating mesh nebuliser (VMN) versus a current standard jet nebuliser (JN), in the Emergency Department (ED).
Participants will be those who meet the inclusion criteria and have a primary diagnosis of COPD, and consent to take part in the study. Operators will be clinical staff including doctors and nurses who will be trained in the use of the nebulisers.
Delivery of current treatment standards utilising a VMN compared to a JN will improve symptom scores in patients attending ED with COPD exacerbations.
Detailed description
This study is a prospective, single-centre, open, randomised study to improve management of acute COPD exacerbation within the Emergency Department. Adults with severe COPD are randomised into 2 groups: vibrating mesh nebuliser or standard jet nebuliser treatment. Salbutamol (5mg) and Ipratropium (0.5mg) will be administered via Aerogen Ultra via valved mask or a standard jet nebuliser via open face mask/. Two further doses of salbutamol to be delivered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Jet Nebuliser | Active comparator | Device: Jet NebuliserStandard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Jet Nebuliser |
| Vibrating Mesh Nebuliser | Experimental | Device: Vibrating Mesh NebuliserStandard therapy of one dose of 0.5 MG Ipratropium and 3 doses of 2.5 MG Salbutamol via Vibrating Mesh Nebuliser |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Primary presentation with acute exacerbation of COPD
Key exclusion criteria (9 listed)
- • Unable to give valid consent
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 |
|---|---|---|
| Jet NebuliserJet Nebuliser | Device | Jet Nebuliser |
| Vibrating Mesh NebuliserAerogen Device | Device | Vibrating Mesh Nebuliser |
Primary outcome
BORG Score
Time frame: 30 minutes post treatment
Change in Reported Dyspnoea. Modified BORG dyspnoea scale. 0 (best) min 10 max (worse)
5 secondary outcomes
Oscillometry
Time frame: 30 minutes post treatment
Escalation of Care
Time frame: During Emergency Department Admission (typically < 4 hours)
Blood Gas
Time frame: 30 minutes post treatment
Completion of Treatment
Time frame: During Emergency Department Admission (typically < 4 hours)
Staff Satisfaction
Time frame: During Emergency Department Admission (typically < 4 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Yes. Data will be stored in Safe Haven GG\&C
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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.
Emergency Department Queen Elizabeth University Hospital
Glasgow, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jet Nebuliser and Vibrating Mesh Nebuliser in people with COPD Exacerbation and COPD, run by NHS Greater Clyde and Glasgow at 1 site in United Kingdom.
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 1 inclusion and 9 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 19 May 2020. 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 United Kingdom. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BORG Score (time frame: 30 minutes post treatment). 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 19 May 2020.