Ignite Creation Date:
2024-05-06 @ 10:33 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03286855
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2017-09-13
Brief Title:
Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Beaumont Hospital
Organization:
Beaumont Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh VM Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 25mgipratropium 05mg 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
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 25mgipratropium 05mg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None