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

Beaumont Hospital

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease; COPD; COPD Exacerbation; Copd Exacerbation Acute

Treatments: Device: Standard Hospital Care; Device: Vibrating Mesh Nebuliser

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03286855

INCA NEB

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 62 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Vibrating Mesh Group

Experimental group

Description:

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.

Treatment:

Device: Vibrating Mesh Nebuliser

Standard Hospital Care Group

Active Comparator group

Description:

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.

Treatment:

Device: Standard Hospital Care