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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686086
• Other study ID #: Beaumont
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2019
• Source: Beaumont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Beaumont Hospital	Aerogen

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory capacity (IC)		Baseline and One hour post nebulised bronchodilator
Secondary	Change in Forced expiratory volume in one second (FEV1)		Baseline and One hour post nebulised bronchodilator
Secondary	Change in forced vital capacity (FVC)		Baseline and One hour post nebulised bronchodilator
Secondary	Change in Borg breathlessness score		Baseline and One hour post nebulised bronchodilator
Secondary	Change in Cough peak flow		Baseline and One hour post nebulised bronchodilator