Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD

Conditions
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Chronic Obstructive Pulmonary Disease, COPD, Copd Exacerbation Acute, COPD Exacerbation

Intervention / Treatment
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* Device: Vibrating Mesh Nebuliser
* Device: Standard Hospital Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective feasibility open-label randomised controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vibrating Mesh Group<br>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. | Device: Vibrating Mesh Nebuliser<br>* 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.<br>* Other names: Aerogen Ultra 13 485 class II medical device (CE 0050);|
| Active Comparator: Standard Hospital Care Group<br>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. | Device: Standard Hospital Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Forced Vital Capacity (FVC) | Forced spirometry measured at bedside | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Borg breathlessness score | Change in patient-reported breathlessness as determined by the Borg breathlessness score | Up to 7 days | 
| Length of Hospital Stay | Defined as time from randomisation to medical decision to discharge patient | Up to 7 days | 
| Change in Inspiratory Capacity (IC) | Relaxed spirometry measured at bedside | 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 | 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 | Up to 30 days | 
| Change in quality of life (QOL): to discharge and to Day 30 | COPD Assessment Test Score | Up to 30 days | 
| Personal Satisfaction Score | End-user questionnaire | Up to 7 days | 
| Change in Forced Expiratory Volume in one second (FEV1) | Forced spirometry measured at bedside | Up to 7 days |