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
Overview
- Phase
- Not Applicable
- Intervention
- Standard hospital jet nebuliser
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Sponsor
- Beaumont Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in inspiratory capacity (IC)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Professor Richard Costello
Professor of Medicine
Beaumont Hospital
Eligibility Criteria
Inclusion Criteria
- •Hospital Inpatients admitted with an acute exacerbation of COPD
- •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
Arms & Interventions
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.
Intervention: Standard hospital jet nebuliser
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.
Intervention: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
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.
Intervention: vibrating mesh nebuliser
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.
Intervention: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule
Outcomes
Primary Outcomes
Change in inspiratory capacity (IC)
Time Frame: Baseline and One hour post nebulised bronchodilator
Secondary Outcomes
- Change in Borg breathlessness score(Baseline and One hour post nebulised bronchodilator)
- Change in Cough peak flow(Baseline and One hour post nebulised bronchodilator)
- 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)