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Trial record 75 of 150 for:    Ipratropium OR atrovent

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

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ClinicalTrials.gov Identifier: NCT02686086
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Aerogen
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: vibrating mesh nebuliser Device: Standard hospital jet nebuliser Drug: Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.

Device: Standard 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

Drug: Combined 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

Active Comparator: 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.
Device: vibrating 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.

Drug: Combined 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




Primary Outcome Measures :
  1. Change in inspiratory capacity (IC) [ Time Frame: Baseline and One hour post nebulised bronchodilator ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686086


Locations
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Ireland
Beaumont Hospital
Dublin, Ireland
Sponsors and Collaborators
Beaumont Hospital
Aerogen
Investigators
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Principal Investigator: Richard W Costello RCSI

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Responsible Party: Professor Richard Costello, Professor of Medicine, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT02686086     History of Changes
Other Study ID Numbers: Beaumont
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ipratropium
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents