Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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
Interventions
DEVICEvibrating 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.
DEVICEStandard 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
DRUGCombined 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
Sponsors
Aerogen
Beaumont Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inspiratory capacity (IC) | Baseline and One hour post nebulised bronchodilator |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Ireland
Outcome results
None listed