Aerogen Nebuliser Versus Standard Nebulised Therapy in Acute Chronic Obstructive Pulmonary Disease

NCT02379065 | Completed

• 1 other identifier: C&W13/087
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are looking at whether a new type of nebuliser (a machine used to deliver drugs to the airways) is better at delivering drugs to the lungs of people with Chronic Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency Departments. The investigators will randomly allocate patients who come into the Emergency Department with an acute episode of the COPD into either the standard nebuliser group or the new nebuliser group. Both groups will receive the same medications, it is only the method of delivering them which will be different.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician

  4 hours

Study Arms (2)

Control nebuliser treatment

ACTIVE COMPARATOR

Both groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines. For this arm, nebuliser will be standard of care. Interventions: Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage) Arterial blood gas changes - pH, pO2, pCO2

Device: Phillips Respironic© mask

Treatment nebuliser treatment

EXPERIMENTAL

Both groups will receive the same bronchodilator pharmacotherapy, in keeping with National Institute of Clinical Excellence guidelines4. For this arm, nebuliser will be Aerogen. Interventions: Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) to be completed by both the patient and clinician Heart rate (as a measure of severity of exacerbation and an indirect measure of salbutamol dosage) Arterial blood gas changes - pH, pO2, pCO2

Device: The Aerogen Aeroneb Solo©

Interventions

The Aerogen Aeroneb Solo© DEVICE

Treatment nebuliser treatment

Phillips Respironic© mask DEVICE

Control nebuliser treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Documented diagnosis of COPD
• Smoking history of at least 10 pack years (i.e. 20 cigarettes a day for 10 years or equivalent) or other risk factor for COPD in history (e.g. occupational exposure or alpha 1 antitrypsin deficiency)
• Age \> 40 years old

You may not qualify if:

• \- A lack of valid consent from patient (e.g. reduced level of consciousness, dementia)
• Patient unable to speak adequate English - as this study is being conducted in the Emergency Department, there is no access to translators
• Patient refusal
• Ambiguity over diagnosis of COPD e.g. possible underlying asthma
• Patients where an alternate diagnosis (such as congestive cardiac failure) cannot be excluded as the acute medical problem leading to shortness of breath

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Roberts, Dr

  Chelsea and Westminster NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 4, 2015
• Study Start: February 1, 2015
• Primary Completion: October 20, 2017
• Study Completion: October 20, 2017
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

GB (1)