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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United Kingdom1 site
  • Chelsea and Westminster Hospital

    London, SW10 9NH

Other trials in United Kingdom

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 groups in NCT02379065
Study groupRoleWhat they receive
Control nebuliser treatmentActive comparatorBoth 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 treatmentExperimentalBoth 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.

  1. 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.

  1. First posted4 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completion20 Oct 2017
  4. Study completion20 Oct 2017

Resources

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)
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

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.

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