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

NCT02686086 | Completed

• 1 other identifier: Beaumont
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory capacity (IC)

  Baseline and One hour post nebulised bronchodilator

Secondary Outcomes (4)

• 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

Study Arms (2)

Standard hospital jet nebuliser

PLACEBO COMPARATOR

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; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule

Vibrating mesh nebuliser

ACTIVE COMPARATOR

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.

Device: vibrating mesh nebuliser; Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule

Interventions

vibrating mesh nebuliser DEVICE

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.

Vibrating mesh nebuliser

Standard hospital jet nebuliser DEVICE

The "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications

Standard hospital jet nebuliser

Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule DRUG

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

Standard hospital jet nebuliser; Vibrating mesh nebuliser

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beaumont Hospital: lead
• Aerogen: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Richard W Costello

  RCSI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 19, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)