A Pilot Comparison Study of Vibrating Mesh Versus Standard Jet Nebuliser for Bronchodilator Delivery in COPD

Chronic Obstructive Pulmonary Disease (COPD) Lung Volume and Symptom Scores Following Bronchodilator Therapy Administration by Vibrating Mesh and Standard Jet Nebulisers: A Pilot Comparison Study

Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.

The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Standard hospital jet nebuliser; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule; Device: vibrating mesh nebuliser

Detailed Description

Treatment of chronic obstructive pulmonary disease (COPD) incorporates various modes of inhalation therapy. The response to treatments is dose dependent thus applying the most efficient device to administer the treatment is integral. Evaluation of the efficacy of nebulisation devices in the treatment of COPD is limited. Technological development in recent years has led to new devices that optimize lung deposition and reduce the time needed for treatment.

The aim of this study is to compare the vibrating mesh and jet nebuliser methods of delivering bronchodilator medication to patients hospitalised with an acute exacerbation of COPD, with respect to lung function and efficacy in spontaneously breathing patients.

Patients admitted to hospital with an exacerbation of COPD and prescribed regular nebulised bronchodilators (combined salbutamol 2.5mg and ipratropium 0.5mg) will be recruited to the study. On one occasion between day 3-7 of admission they will perform pulmonary function testing namely measurement of Forced Expiratory Volume in 1 second(FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC) and cough peak flow. They will also complete the Borg breathlessness score. Measurements will be recorded at baseline (pre-bronchodilator administration) and one hour post-nebulised bronchodilator.

Patients will be randomised to receive their nebulised bronchodilators via the standard hospital jet nebuliser or via a vibrating mesh nebuliser(Aerogen Solo).

Change in lung function and symptom measures between baseline and one-hour post nebulisation will be analysed to look for any significant difference between the two groups

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hospital Inpatients admitted with an acute exacerbation of COPD
• Age >40
• COPD Stage 2-4 moderate to severe (FEV1/FVC <0.70;FEV1<80%)
• History of physician-diagnosed COPD
• COPD exacerbation between day 2 and day 7 of admission

Exclusion Criteria:

• Confusion
• Significant hypoxia/unstable medical condition
• Allergy or contraindication to salbutamol and/or ipratropium
• Pneumonia
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard hospital jet nebuliser; Patients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a standard hospital jet nebuliser. Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation.	Device: Standard hospital jet nebuliser; The "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule; All patients admitted to hospital with an exacerbation of COPD are administered nebulised bronchodilators (salbutamol 2.5mg/ipratropium 0.5mg combination) as standard of care
Active Comparator: Vibrating mesh nebuliser; Patients admitted to hospital with an acute exacerbation of COPD and prescribed nebulised bronchodilator therapy (combined short-acting salbutamol 2.5mg and ipratropium 0.5mg) will receive their prescribed medication via a vibrating mesh nebuliser (Aerogen Solo) rather than the standard hospital nebuliser Spirometry, lung volume measurement and symptom score (Borg breathlessness scale) will be recorded pre-nebulisation and at one hour post-nebulisation.	Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule; All patients admitted to hospital with an exacerbation of COPD are administered nebulised bronchodilators (salbutamol 2.5mg/ipratropium 0.5mg combination) as standard of care; Device: vibrating mesh nebuliser; The Aerogen Solo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in inspiratory capacity (IC)	Baseline and One hour post nebulised bronchodilator

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Forced expiratory volume in one second (FEV1)	Baseline and One hour post nebulised bronchodilator
Change in forced vital capacity (FVC)	Baseline and One hour post nebulised bronchodilator
Change in Borg breathlessness score	Baseline and One hour post nebulised bronchodilator
Change in Cough peak flow	Baseline and One hour post nebulised bronchodilator

Collaborators and Investigators

• Sponsor: Beaumont Hospital
• Collaborators: Aerogen
• Investigators: Principal Investigator: Richard W Costello, RCSI

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Ipratropium
• Other Study ID Numbers: Beaumont

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO