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Completed

NCT Number: NCT02686086

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital

Dublin, Ireland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrating Mesh Nebuliser

Device

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.

Standard hospital jet nebuliser

Device

The "standard hospital jet nebuliser" refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications

Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule

Drug

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 outcomes

  1. Change in inspiratory capacity (IC)

    Time frame: Baseline and One hour post nebulised bronchodilator

Secondary outcomes

  1. Change in Forced expiratory volume in one second (FEV1)

    Time frame: Baseline and One hour post nebulised bronchodilator

  2. Change in forced vital capacity (FVC)

    Time frame: Baseline and One hour post nebulised bronchodilator

  3. Change in Borg breathlessness score

    Time frame: Baseline and One hour post nebulised bronchodilator

  4. Change in Cough peak flow

    Time frame: Baseline and One hour post nebulised bronchodilator

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Collaborators

  • Aerogen

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 19, 2016
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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