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
NCT number | NCT02686086 |
Other study ID # | Beaumont |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | July 2017 |
Verified date | July 2019 |
Source | Beaumont Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Beaumont Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Beaumont Hospital | Aerogen |
Ireland,
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 |
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