Clinical trial NCT03286855: Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized Controlled Trial of Bronchodilator Delivery by Vibrating Mesh (VM) Nebuliser Versus Small Volume Nebuliser During an Acute Exacerbation of COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Copd Exacerbation Acute
COPD Exacerbation
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: Aerogen
First posted: 2017-09-19
Enrollment: 62
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective feasibility open-label randomised controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Forced Vital Capacity (FVC)
timeFrame: Up to 7 days
Secondary outcomes:
measure: Change in Borg breathlessness score
timeFrame: Up to 7 days
measure: Length of Hospital Stay
timeFrame: Up to 7 days
measure: Change in Inspiratory Capacity (IC)
timeFrame: Up to 7 days
measure: Rate of re-exacerbation at Day 30
timeFrame: Up to 30 days
measure: Time to re-exacerbation .
timeFrame: Up to 30 days
measure: Change in quality of life (QOL): to discharge and to Day 30
timeFrame: Up to 30 days
measure: Personal Satisfaction Score
timeFrame: Up to 7 days
measure: Change in Forced Expiratory Volume in one second (FEV1)
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Royal College of Surgeons in Ireland
name: Richard W Costello
role: PRINCIPAL_INVESTIGATOR
References: