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

NCT03286855 | Completed

• 1 other identifier: INCA NEB
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Forced Vital Capacity (FVC)

  Forced spirometry measured at bedside

  Up to 7 days

Secondary Outcomes (8)

• Change in Borg breathlessness score

  Up to 7 days

• Length of Hospital Stay

  Up to 7 days

• Change in Inspiratory Capacity (IC)

  Up to 7 days

• Rate of re-exacerbation at Day 30

  Up to 30 days

• Time to re-exacerbation .

  Up to 30 days

Study Arms (2)

Vibrating Mesh Group

EXPERIMENTAL

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

Standard Hospital Care Group

ACTIVE COMPARATOR

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

Interventions

Vibrating Mesh Nebuliser 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.

Also known as: Aerogen Ultra 13 485 class II medical device (CE 0050)

Vibrating Mesh Group

Standard Hospital Care 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.

Standard Hospital Care Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beaumont Hospital: lead
• Aerogen: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard W Costello

  Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Respiratory Physician

Model Details: prospective feasibility open-label randomised controlled trial

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 19, 2017
• Study Start: October 18, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)