COPDNCT02379065
Aerogen Nebuliser Versus Standard Nebulised Therapy in Acute Chronic Obstructive Pulmonary Disease
A study testing The Aerogen Aeroneb Solo© and Phillips Respironic© mask in people with COPD, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators are looking at whether a new type of nebuliser (a machine used to deliver drugs to the airways) is better at delivering drugs to the lungs of people with Chronic Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency Departments. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- The Aerogen Aeroneb Solo© and Phillips Respironic© mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to 20 Oct 2017
- 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
- - Documented diagnosis of COPD
- Smoking history of at least 10 pack years (i.e. 20 cigarettes a day for 10 years or equivalent) or other risk factor for COPD in history (e.g. occupational exposure or alpha 1 antitrypsin deficiency)
- Age > 40 years old
Who cannot join
- - A lack of valid consent from patient (e.g. reduced level of consciousness, dementia)
- Patient unable to speak adequate English - as this study is being conducted in the Emergency Department, there is no access to translators
- Patient refusal
- Ambiguity over diagnosis of COPD e.g. possible underlying asthma
- Patients where an alternate diagnosis (such as congestive cardiac failure) cannot be excluded as the acute medical problem leading to shortness of breath
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesh Nebuliser Versus Standard Jet Nebuliser Therapy in Acute Chronic Obstructive Pulmonary Disease in the Emergency Department
The investigators are looking at whether a new type of nebuliser (a machine used to deliver drugs to the airways) is better at delivering drugs to the lungs of people with Chronic Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency Departments. The investigators will randomly allocate patients who come into the Emergency Department with an acute episode of the COPD into either the standard nebuliser group or the new nebuliser group.
Both groups will receive the same medications, it is only the method of delivering them which will be different.
Read the detailed description
Chronic Obstructive Pulmonary Disease presents a significant burden on Emergency Departments and acute medical services, accounting for approximately 90,000 hospital admissions a year, with an average stay lasting 11 days. COPD accounts for 10% of acute hospital admissions, therefore any method of improving health outcomes and reducing the burden on acute services will benefit patients twofold.
Severity of acute COPD is based on clinical indicators such as patient perceived breathlessness, arterial blood gas analysis and respiratory rate. Although breathlessness is a subjective marker, multiple scoring systems have been devised in an attempt to standardise this in order to see an objective improvement in the patient. One of the most commonly used and repeatedly validated scoring systems is the BORG score, which has been shown to effectively demonstrate improvement in breathlessness in the emergency setting .
Nebulised bronchodilator therapy is the mainstay of treatment, as described in the National Institute of Clinical Excellence guidelines. Delivery of bronchodilators (salbutamol and ipratropium) is through a standard facemask - in this Trust it is a Phillips Respironic© mask. Drugs delivery is variable through a nebuliser mask and it is difficult to measure exactly how much of the drug is being delivered to the more distal bronchial tree. Furthermore, this can be highly variable between patients depending on how well the mask fits and patient tolerance, amongst other factors.
Various attempts have been made to improve drug delivery in acute setting such as a spacer and a hood (within paediatric asthmatic patients) , . However, they have all showed that the clinical outcomes are the same regardless of the method of delivery.
Clinical assessment is based on a combination of objective and subjective parameters. Within the Emergency Department, these include both patient and clinician perception of improvement in symptoms (primarily shortness of breath). Assessment also includes more objective measurements such as oxygen saturation, arterial blood gas measurements and end tidal CO2 measurements when available.
There are many challenges that we face specifically within the Emergency Department with patients with COPD. As we are seeing patients as soon as they enter the hospital, initial therapy may have already been administered by the ambulance service so any assessment will be slightly biased and the patient may initially appear better than they actually are. Furthermore, there are often burdens on Emergency Departments during busy periods during the winter, meaning it is not always possible to give patients instant treatment or to be seen immediately by a doctor, particularly if there are more unwell patients based on the triage system.
In addition, some of the more objective measures used in previous trials such as bedside spirometry are not practical in the Emergency Department for several reasons. Firstly, when a patient is acutely short of breath they will not be able to perform spirometry properly. Secondly, as this is not something done routinely in the Emergency Department, both doctors and nurses may not be properly trained to carry this out and we may obtain falsely high or low results.
The Aerogen Aeroneb Solo© is a new nebuliser which is hypothesised to increase drug delivery to peripheral bronchi. Previous studies have showed that it delivers up to 4 times more drug than jet nebulisers and up to 3 times as much as metered dose inhalers. However, this will be its first study with the adapter in human subjects and its first study specifically for COPD.
- Conditions
- COPD
- Being tested
- The Aerogen Aeroneb Solo©, Phillips Respironic© mask
- 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.
The Aerogen Aeroneb Solo©Device
Phillips Respironic© maskDevice
| Study group | Role | What they receive |
|---|---|---|
| Control nebuliser treatment | Active comparator | Both groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines. For this arm, nebuliser will be standard of care.
Interventions:
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician
Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage)
Arterial blood gas changes - pH, pO2, pCO2 Receives: Device: Phillips Respironic© mask |
| Treatment nebuliser treatment | Experimental | Both groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines4. For this arm, nebuliser will be Aerogen.
Interventions:
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician
Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage)
Arterial blood gas changes - pH, pO2, pCO2 Receives: Device: The Aerogen Aeroneb Solo© |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion20 Oct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Roberts, Dr, Principal investigator, Chelsea and Westminster NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379065
- Sponsor's protocol ID
- C&W13/087
- Status last verified
- Jan 2021
- First submitted
- 23 Feb 2015
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Nebuliser Versus Standard Jet Nebuliser Therapy in Acute Chronic Obstructive Pulmonary Disease in the Emergency Department
- ClinicalTrials.gov ID
- NCT02379065
- Acronym / sponsor ID
- C&W13/087
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 4 Mar 2015 (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 investigators are looking at whether a new type of nebuliser (a machine used to deliver drugs to the airways) is better at delivering drugs to the lungs of people with Chronic Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency Departments. The investigators will randomly allocate patients who come into the Emergency Department with an acute episode of the COPD into either the standard nebuliser group or the new nebuliser group.
Both groups will receive the same medications, it is only the method of delivering them which will be different.
Detailed description
Chronic Obstructive Pulmonary Disease presents a significant burden on Emergency Departments and acute medical services, accounting for approximately 90,000 hospital admissions a year, with an average stay lasting 11 days. COPD accounts for 10% of acute hospital admissions, therefore any method of improving health outcomes and reducing the burden on acute services will benefit patients twofold.
Severity of acute COPD is based on clinical indicators such as patient perceived breathlessness, arterial blood gas analysis and respiratory rate. Although breathlessness is a subjective marker, multiple scoring systems have been devised in an attempt to standardise this in order to see an objective improvement in the patient. One of the most commonly used and repeatedly validated scoring systems is the BORG score, which has been shown to effectively demonstrate improvement in breathlessness in the emergency setting .
Nebulised bronchodilator therapy is the mainstay of treatment, as described in the National Institute of Clinical Excellence guidelines. Delivery of bronchodilators (salbutamol and ipratropium) is through a standard facemask - in this Trust it is a Phillips Respironic© mask. Drugs delivery is variable through a nebuliser mask and it is difficult to measure exactly how much of the drug is being delivered to the more distal bronchial tree. Furthermore, this can be highly variable between patients depending on how well the mask fits and patient tolerance, amongst other factors.
Various attempts have been made to improve drug delivery in acute setting such as a spacer and a hood (within paediatric asthmatic patients) , . However, they have all showed that the clinical outcomes are the same regardless of the method of delivery.
Clinical assessment is based on a combination of objective and subjective parameters. Within the Emergency Department, these include both patient and clinician perception of improvement in symptoms (primarily shortness of breath). Assessment also includes more objective measurements such as oxygen saturation, arterial blood gas measurements and end tidal CO2 measurements when available.
There are many challenges that we face specifically within the Emergency Department with patients with COPD. As we are seeing patients as soon as they enter the hospital, initial therapy may have already been administered by the ambulance service so any assessment will be slightly biased and the patient may initially appear better than they actually are. Furthermore, there are often burdens on Emergency Departments during busy periods during the winter, meaning it is not always possible to give patients instant treatment or to be seen immediately by a doctor, particularly if there are more unwell patients based on the triage system.
In addition, some of the more objective measures used in previous trials such as bedside spirometry are not practical in the Emergency Department for several reasons. Firstly, when a patient is acutely short of breath they will not be able to perform spirometry properly. Secondly, as this is not something done routinely in the Emergency Department, both doctors and nurses may not be properly trained to carry this out and we may obtain falsely high or low results.
The Aerogen Aeroneb Solo© is a new nebuliser which is hypothesised to increase drug delivery to peripheral bronchi. Previous studies have showed that it delivers up to 4 times more drug than jet nebulisers and up to 3 times as much as metered dose inhalers. However, this will be its first study with the adapter in human subjects and its first study specifically for COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control nebuliser treatment | Active comparator | Device: Phillips Respironic© maskBoth groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines. For this arm, nebuliser will be standard of care. Interventions: Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage) Arterial blood gas changes - pH, pO2, pCO2 |
| Treatment nebuliser treatment | Experimental | Device: The Aerogen Aeroneb Solo©Both groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines4. For this arm, nebuliser will be Aerogen. Interventions: Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage) Arterial blood gas changes - pH, pO2, pCO2 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Documented diagnosis of COPD
- Smoking history of at least 10 pack years (i.e. 20 cigarettes a day for 10 years or equivalent) or other risk factor for COPD in history (e.g. occupational exposure or alpha 1 antitrypsin deficiency)
- Age > 40 years old
Key exclusion criteria (5 listed)
- - A lack of valid consent from patient (e.g. reduced level of consciousness, dementia)
- Patient unable to speak adequate English - as this study is being conducted in the Emergency Department, there is no access to translators
- Patient refusal
- Ambiguity over diagnosis of COPD e.g. possible underlying asthma
- Patients where an alternate diagnosis (such as congestive cardiac failure) cannot be excluded as the acute medical problem leading to shortness of breath
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 |
|---|---|---|
| The Aerogen Aeroneb Solo© | Device | Treatment nebuliser treatment |
| Phillips Respironic© mask | Device | Control nebuliser treatment |
Primary outcome
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician
Time frame: 4 hours
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 1 Feb 2021.
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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.
Patrick Roberts, Dr principal investigator
Chelsea and Westminster NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Aerogen Aeroneb Solo© and Phillips Respironic© mask in people with COPD, run by Chelsea and Westminster NHS Foundation Trust 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 3 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 1 Feb 2021. 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?
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?
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician (time frame: 4 hours). 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 1 Feb 2021.