NCT02686086

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beaumont Hospital · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2016-02-19
• Last updated: 2019-07-18

Locations

1 site across 1 country: Ireland