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

NCT ID: NCT03286855

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2018-09-30

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibrating Mesh Group

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.

Group Type: EXPERIMENTAL

Vibrating Mesh Nebuliser

Intervention Type: DEVICE

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.

Standard Hospital Care Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Hospital Care

Intervention Type: DEVICE

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.

Interventions

Vibrating Mesh Nebuliser

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.

Intervention Type: DEVICE

Standard Hospital Care

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.

Intervention Type: DEVICE

Other Intervention Names

Aerogen Ultra 13 485 class II medical device (CE 0050)

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerogen

INDUSTRY

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Richard Costello

Consultant Respiratory Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard W Costello

Role: PRINCIPAL_INVESTIGATOR

Royal College of Surgeons in Ireland

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

INCA NEB

Identifier Type: -

Identifier Source: org_study_id