Chronic Obstructive Pulmonary Disease (COPD)NCT02686086
A Pilot Comparison Study of Vibrating Mesh Versus Standard Jet Nebuliser for Bronchodilator Delivery in COPD
A study testing vibrating mesh nebuliser, Standard hospital jet nebuliser and Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule in people with Chronic Obstructive Pulmonary Disease (COPD), run by Beaumont Hospital at 1 site in Ireland.
Trial summary
Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- vibrating mesh nebuliser, Standard hospital jet nebuliser and Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Feb 2016to Jul 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
- Hospital Inpatients admitted with an acute exacerbation of COPD
- Age >40
- COPD Stage 2-4 moderate to severe (FEV1/FVC <0.70;FEV1<80%)
- History of physician-diagnosed COPD
- COPD exacerbation between day 2 and day 7 of admission
Who cannot join
- Confusion
- Significant hypoxia/unstable medical condition
- Allergy or contraindication to salbutamol and/or ipratropium
- Pneumonia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Obstructive Pulmonary Disease (COPD) Lung Volume and Symptom Scores Following Bronchodilator Therapy Administration by Vibrating Mesh and Standard Jet Nebulisers: A Pilot Comparison Study
Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.
The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.
Read the detailed description
Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.
The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.
Patients admitted to hospital with an exacerbation of COPD and prescribed regular nebulised bronchodilators (combined salbutamol 2.5mg and ipratropium 0.5mg) will be recruited to the study. On one occasion between day 3-7 of admission they will perform pulmonary function testing namely measurement of Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC) and cough peak flow. They will also complete the Borg breathlessness score. Measurements will be recorded at baseline (pre-bronchodilator administration) and one hour post-nebulised bronchodilator.
Patients will be randomised to receive their nebulised bronchodilators via the standard hospital jet nebuliser or via a vibrating mesh nebuliser(Aerogen Solo).
Change in lung function and symptom measures between baseline and one-hour post nebulisation will be analysed to look for any significant difference between the two groups
- Being tested
- vibrating mesh nebuliser, Standard hospital jet nebuliser, Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
- 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
The Aerogen Solo 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 jet nebuliserDevice
The "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications
Combined salbutamol 2.5 mg and ipratropium 0.5mg nebuleDrug
All patients admitted to hospital with an exacerbation of COPD are administered nebulised bronchodilators (salbutamol 2.5mg/ipratropium 0.5mg combination) as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard hospital jet nebuliser | Placebo comparator | Patients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a standard hospital jet nebuliser.
Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation. Receives: Device: Standard hospital jet nebuliser; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule |
| Vibrating mesh nebuliser | Active comparator | Patients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a vibrating mesh nebuliser (Aerogen Solo) rather than the standard hospital nebuliser Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation. Receives: Device: vibrating mesh nebuliser; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inspiratory capacity (IC)
Measured: Baseline and One hour post nebulised bronchodilator
Secondary outcomes (4)
Change in Forced expiratory volume in one second (FEV1)
Measured: Baseline and One hour post nebulised bronchodilator
Change in forced vital capacity (FVC)
Measured: Baseline and One hour post nebulised bronchodilator
Change in Borg breathlessness score
Measured: Baseline and One hour post nebulised bronchodilator
Change in Cough peak flow
Measured: Baseline and One hour post nebulised bronchodilator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, RCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686086
- Sponsor's protocol ID
- Beaumont
- Status last verified
- Jul 2019
- First submitted
- 10 Feb 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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
- Chronic Obstructive Pulmonary Disease (COPD) Lung Volume and Symptom Scores Following Bronchodilator Therapy Administration by Vibrating Mesh and Standard Jet Nebulisers: A Pilot Comparison Study
- ClinicalTrials.gov ID
- NCT02686086
- Acronym / sponsor ID
- Beaumont
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 19 Feb 2016 (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.
Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.
The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.
Detailed description
Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.
The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.
Patients admitted to hospital with an exacerbation of COPD and prescribed regular nebulised bronchodilators (combined salbutamol 2.5mg and ipratropium 0.5mg) will be recruited to the study. On one occasion between day 3-7 of admission they will perform pulmonary function testing namely measurement of Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC) and cough peak flow. They will also complete the Borg breathlessness score. Measurements will be recorded at baseline (pre-bronchodilator administration) and one hour post-nebulised bronchodilator.
Patients will be randomised to receive their nebulised bronchodilators via the standard hospital jet nebuliser or via a vibrating mesh nebuliser(Aerogen Solo).
Change in lung function and symptom measures between baseline and one-hour post nebulisation will be analysed to look for any significant difference between the two groups
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard hospital jet nebuliser | Placebo comparator | Device: Standard hospital jet nebuliser, Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebulePatients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a standard hospital jet nebuliser. Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation. |
| Vibrating mesh nebuliser | Active comparator | Device: vibrating mesh nebuliser, Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebulePatients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a vibrating mesh nebuliser (Aerogen Solo) rather than the standard hospital nebuliser Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospital Inpatients admitted with an acute exacerbation of COPD
- Age >40
- COPD Stage 2-4 moderate to severe (FEV1/FVC <0.70;FEV1<80%)
- History of physician-diagnosed COPD
- COPD exacerbation between day 2 and day 7 of admission
Key exclusion criteria (5 listed)
- Confusion
- Significant hypoxia/unstable medical condition
- Allergy or contraindication to salbutamol and/or ipratropium
- Pneumonia
- Pregnancy
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 nebuliserThe Aerogen Solo 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 nebuliser |
| Standard hospital jet nebuliserThe "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications | Device | Standard hospital jet nebuliser |
| Combined salbutamol 2.5 mg and ipratropium 0.5mg nebuleAll patients admitted to hospital with an exacerbation of COPD are administered nebulised bronchodilators (salbutamol 2.5mg/ipratropium 0.5mg combination) as standard of care | Drug | Standard hospital jet nebuliser, Vibrating mesh nebuliser |
Primary outcome
Change in inspiratory capacity (IC)
Time frame: Baseline and One hour post nebulised bronchodilator
4 secondary outcomes
Change in Forced expiratory volume in one second (FEV1)
Time frame: Baseline and One hour post nebulised bronchodilator
Change in forced vital capacity (FVC)
Time frame: Baseline and One hour post nebulised bronchodilator
Change in Borg breathlessness score
Time frame: Baseline and One hour post nebulised bronchodilator
Change in Cough peak flow
Time frame: Baseline and One hour post nebulised bronchodilator
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
Related trials for Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
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
RCSI
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, Standard hospital jet nebuliser and Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule in people with Chronic Obstructive Pulmonary Disease (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 5 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 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. Some participants in this study may receive a placebo. 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 inspiratory capacity (IC) (time frame: Baseline and One hour post nebulised bronchodilator). 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.