Clinical trial NCT02686086: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
Collaborators: name: Aerogen
First posted: 2016-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in inspiratory capacity (IC)
timeFrame: Baseline and One hour post nebulised bronchodilator
Secondary outcomes:
measure: Change in Forced expiratory volume in one second (FEV1)
timeFrame: Baseline and One hour post nebulised bronchodilator
measure: Change in forced vital capacity (FVC)
timeFrame: Baseline and One hour post nebulised bronchodilator
measure: Change in Borg breathlessness score
timeFrame: Baseline and One hour post nebulised bronchodilator
measure: Change in Cough peak flow
timeFrame: Baseline and One hour post nebulised bronchodilator
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: RCSI
name: Richard W Costello
role: PRINCIPAL_INVESTIGATOR
References: