Chronic Obstructive Pulmonary DiseaseNCT03286855
Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Vibrating Mesh Nebuliser and Standard Hospital Care in people with Chronic Obstructive Pulmonary Disease and COPD, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
When patients get an attack of COPD, one of the main treatments is regular nebulised medications called bronchodilators. These medications act by opening up the airways allowing patients to breathe easier and to reduce shortness of breath. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD, Copd Exacerbation Acute
- What is being tested?
- Vibrating Mesh Nebuliser and Standard Hospital Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIreland
- Study dates
- 18 Oct 2017to 30 Sep 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission with acute exacerbation of COPD within 24 hours of presentation to hospital
- Age >40
- Confirmed COPD diagnosis (FEV1/FVC <0.70 on spirometry)
- Willing to participate in the study and provide informed consent
Who cannot join
- Admission for reason other than COPD exacerbation e.g. Heart Failure
- Acute confusion as per clinical team
- Allergy or contraindication to combined bronchodilator medication
- Severe respiratory sepsis as evident by temperature >38 degrees and/or lobar pneumonia on Chest Radiograph
- Sustained tachycardia >120bpm
- Patients with very advanced COPD, admitted for palliative or long term care
- Patients re-admitted within 90 days who have already been enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD
When patients get an attack of COPD, one of the main treatments is regular nebulised medications called bronchodilators. These medications act by opening up the airways allowing patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase the amount of medication that gets into the lungs compared to the standard nebuliser usually used in hospital. This study is being done to assess whether increasing the amount of medication getting into the lungs using these newer nebulisers will help patients recover from a COPD exacerbation.
Read the detailed description
COPD is a common chronic respiratory disease. It is characterised by repeated episodes of acute worsening of symptoms of cough, wheeze and breathlessness called exacerbations. Exacerbations result in patients having to present to hospital for treatment. In Ireland more than one-fifth of all inpatient hospital days for the treatment of respiratory complaints are for the treatment of COPD. The administration of bronchodilators (medication to open the airway) is a central component of the treatment of COPD exacerbation. In the hospital setting these are most commonly administered via a nebuliser. The standard of care in our institution is the Hudson micromist small volume nebuliser.
However, previous studies have shown that Vibrating mesh (VM) nebulisers result in greater deposition of medication to the lungs compared to small volume nebulisers. In addition they resulted in greater improvements in lung function and breathlessness.
This study will assess the efficacy of the Aerogen Ultra VM nebuliser in a real-world setting. The VM nebuliser is readily available for use in the clinical setting and is used to administer bronchodilator therapy, within the terms of its CE Mark. This nebuliser is already in routine use in hospitals within the Royal College of Surgeons in Ireland (RCSI) hospital group.
Patients hospitalised with an exacerbation of COPD will be recruited. There will be two study groups. Group 1 (VM Group): will receive bronchodilator (salbutamol 2.5mg/ipratropium 0.5mg) by Vibrating Mesh Nebuliser (Aerogen Ultra) with facemask and Group 2 (Standard Hospital Care): will receive bronchodilator by small volume nebuliser (Hudson Micromist) via facemask as per standard care.
Both groups will receive bronchodilator therapy four times a day which has already been prescribed by their medical team, and in accordance with recommended guidelines for treatment of COPD exacerbations. Patients will use the nebuliser for the duration of hospital stay or a maximum of 7 days. Lung function and breathlessness scores will be recorded. The aim of this study is to demonstrate that better medication delivery by VM nebulizer during an exacerbation of COPD will lead to greater bronchodilation, shorter recovery time and reduced hospital length of stay.
- Being tested
- Vibrating Mesh Nebuliser, Standard Hospital Care
- 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.
Vibrating Mesh NebuliserDevice
Also called Aerogen Ultra 13 485 class II medical device (CE 0050)
The Aerogen Ultra vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers.
Standard Hospital CareDevice
The "standard hospital care" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications. This is the Hudson micromist small volume nebuliser.
| Study group | Role | What they receive |
|---|---|---|
| Vibrating Mesh Group | Experimental | Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Aerogen Ultra (CE 0050) vibrating mesh Nebuliser. Receives: Device: Vibrating Mesh Nebuliser |
| Standard Hospital Care Group | Active comparator | Patient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Hudson micromist small volume nebuliser which is the standard of care at our institution. Receives: Device: Standard Hospital Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Forced Vital Capacity (FVC)
Forced spirometry measured at bedside
Measured: Up to 7 days
Secondary outcomes (8)
Change in Borg breathlessness score
Change in patient-reported breathlessness as determined by the Borg breathlessness score
Measured: Up to 7 days
Length of Hospital Stay
Defined as time from randomisation to medical decision to discharge patient
Measured: Up to 7 days
Change in Inspiratory Capacity (IC)
Relaxed spirometry measured at bedside
Measured: Up to 7 days
Rate of re-exacerbation at Day 30
The number of repeat exacerbations following discharged from hospital. Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids
Measured: Up to 30 days
Time to re-exacerbation .
The time to first repeat exacerbation following discharge.Exacerbation defined as an acute change in respiratory symptoms necessitating administration of antibiotics and/or steroids
Measured: Up to 30 days
Change in quality of life (QOL): to discharge and to Day 30
COPD Assessment Test Score
Measured: Up to 30 days
Personal Satisfaction Score
End-user questionnaire
Measured: Up to 7 days
Change in Forced Expiratory Volume in one second (FEV1)
Forced spirometry measured at bedside
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start18 Oct 2017
- Primary completion30 Jun 2018
- Study completion30 Sep 2018
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.
- 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
- Parallel groups
- Model description
- prospective feasibility open-label randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aerogen
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard W Costello, Principal investigator, Royal College of Surgeons in Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286855
- Sponsor's protocol ID
- INCA NEB
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2017
- Last updated
- 18 Jul 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 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT03286855
- Acronym / sponsor ID
- INCA NEB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 19 Sep 2017 (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.
When patients get an attack of COPD, one of the main treatments is regular nebulised medications called bronchodilators. These medications act by opening up the airways allowing patients to breathe easier and to reduce shortness of breath. Newer nebulisers may increase the amount of medication that gets into the lungs compared to the standard nebuliser usually used in hospital. This study is being done to assess whether increasing the amount of medication getting into the lungs using these newer nebulisers will help patients recover from a COPD exacerbation.
Detailed description
COPD is a common chronic respiratory disease. It is characterised by repeated episodes of acute worsening of symptoms of cough, wheeze and breathlessness called exacerbations. Exacerbations result in patients having to present to hospital for treatment. In Ireland more than one-fifth of all inpatient hospital days for the treatment of respiratory complaints are for the treatment of COPD. The administration of bronchodilators (medication to open the airway) is a central component of the treatment of COPD exacerbation. In the hospital setting these are most commonly administered via a nebuliser. The standard of care in our institution is the Hudson micromist small volume nebuliser.
However, previous studies have shown that Vibrating mesh (VM) nebulisers result in greater deposition of medication to the lungs compared to small volume nebulisers. In addition they resulted in greater improvements in lung function and breathlessness.
This study will assess the efficacy of the Aerogen Ultra VM nebuliser in a real-world setting. The VM nebuliser is readily available for use in the clinical setting and is used to administer bronchodilator therapy, within the terms of its CE Mark. This nebuliser is already in routine use in hospitals within the Royal College of Surgeons in Ireland (RCSI) hospital group.
Patients hospitalised with an exacerbation of COPD will be recruited. There will be two study groups. Group 1 (VM Group): will receive bronchodilator (salbutamol 2.5mg/ipratropium 0.5mg) by Vibrating Mesh Nebuliser (Aerogen Ultra) with facemask and Group 2 (Standard Hospital Care): will receive bronchodilator by small volume nebuliser (Hudson Micromist) via facemask as per standard care.
Both groups will receive bronchodilator therapy four times a day which has already been prescribed by their medical team, and in accordance with recommended guidelines for treatment of COPD exacerbations. Patients will use the nebuliser for the duration of hospital stay or a maximum of 7 days. Lung function and breathlessness scores will be recorded. The aim of this study is to demonstrate that better medication delivery by VM nebulizer during an exacerbation of COPD will lead to greater bronchodilation, shorter recovery time and reduced hospital length of stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective feasibility open-label randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Vibrating Mesh Group | Experimental | Device: Vibrating Mesh NebuliserPatient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Aerogen Ultra (CE 0050) vibrating mesh Nebuliser. |
| Standard Hospital Care Group | Active comparator | Device: Standard Hospital CarePatient's admitted with an acute exacerbation of COPD and prescribed nebulised combined salbutamol 2.5mg/ipratropium bromide 0.5mg (Combivent) are randomised to receive their treatment via the Hudson micromist small volume nebuliser which is the standard of care at our institution. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission with acute exacerbation of COPD within 24 hours of presentation to hospital
- Age >40
- Confirmed COPD diagnosis (FEV1/FVC <0.70 on spirometry)
- Willing to participate in the study and provide informed consent
Key exclusion criteria (7 listed)
- Admission for reason other than COPD exacerbation e.g. Heart Failure
- Acute confusion as per clinical team
- Allergy or contraindication to combined bronchodilator medication
- Severe respiratory sepsis as evident by temperature >38 degrees and/or lobar pneumonia on Chest Radiograph
- Sustained tachycardia >120bpm
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 |
|---|---|---|
| Vibrating Mesh NebuliserAlso: Aerogen Ultra 13 485 class II medical device (CE 0050)The Aerogen Ultra vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers. | Device | Vibrating Mesh Group |
| Standard Hospital CareThe "standard hospital care" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications. This is the Hudson micromist small volume nebuliser. | Device | Standard Hospital Care Group |
Primary outcome
Change in Forced Vital Capacity (FVC)
Time frame: Up to 7 days
Forced spirometry measured at bedside
8 secondary outcomes
Change in Borg breathlessness score
Time frame: Up to 7 days
Length of Hospital Stay
Time frame: Up to 7 days
Change in Inspiratory Capacity (IC)
Time frame: Up to 7 days
Rate of re-exacerbation at Day 30
Time frame: Up to 30 days
Time to re-exacerbation .
Time frame: Up to 30 days
Change in quality of life (QOL): to discharge and to Day 30
Time frame: Up to 30 days
Personal Satisfaction Score
Time frame: Up to 7 days
Change in Forced Expiratory Volume in one second (FEV1)
Time frame: Up to 7 days
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 18 Jul 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.
Richard W Costello principal investigator
Royal College of Surgeons in Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Mesh Nebuliser and Standard Hospital Care in people with Chronic Obstructive Pulmonary Disease and COPD, run by Beaumont Hospital at 1 site in Ireland.
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 4 inclusion and 7 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 18 Jul 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 Ireland. 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?
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?
Change in Forced Vital Capacity (FVC) (time frame: Up to 7 days). 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 18 Jul 2019.