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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
vibrating mesh nebuliser
Standard hospital jet nebuliser
Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
Sponsored by
Beaumont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Standard hospital jet nebuliser

Vibrating mesh nebuliser

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in inspiratory capacity (IC)

Secondary Outcome Measures

Change in Forced expiratory volume in one second (FEV1)
Change in forced vital capacity (FVC)
Change in Borg breathlessness score
Change in Cough peak flow

Full Information

First Posted
February 10, 2016
Last Updated
July 17, 2019
Sponsor
Beaumont Hospital
Collaborators
Aerogen
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1. Study Identification

Unique Protocol Identification Number
NCT02686086
Brief Title
A Pilot Comparison Study of Vibrating Mesh Versus Standard Jet Nebuliser for Bronchodilator Delivery in COPD
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beaumont Hospital
Collaborators
Aerogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard hospital jet nebuliser
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Vibrating mesh nebuliser
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
vibrating mesh nebuliser
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard hospital jet nebuliser
Intervention Description
The "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications
Intervention Type
Drug
Intervention Name(s)
Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in inspiratory capacity (IC)
Time Frame
Baseline and One hour post nebulised bronchodilator
Secondary Outcome Measure Information:
Title
Change in Forced expiratory volume in one second (FEV1)
Time Frame
Baseline and One hour post nebulised bronchodilator
Title
Change in forced vital capacity (FVC)
Time Frame
Baseline and One hour post nebulised bronchodilator
Title
Change in Borg breathlessness score
Time Frame
Baseline and One hour post nebulised bronchodilator
Title
Change in Cough peak flow
Time Frame
Baseline and One hour post nebulised bronchodilator

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Costello
Organizational Affiliation
RCSI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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