Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
54 participants
INTERVENTIONAL
2018-09-17
2019-12-31
Brief Summary
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However, the procedure can be slightly uncomfortable for patients. This study aims to assess the differences in participants' tolerability of sputum induction, by comparing two different nebulisers when performing the procedure.
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Detailed Description
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If participants are unable to produce a sputum sample after completion of the induction procedure, physiotherapy techniques may be performed. This is an exploratory objective to establish whether these techniques may help in the event of unsuccessful procedures.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Omron
Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
Omron NE-U17 Ultrasonic nebuliser
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
Akita Jet Inhalation System
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Akita
Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
Omron NE-U17 Ultrasonic nebuliser
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
Akita Jet Inhalation System
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Interventions
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Omron NE-U17 Ultrasonic nebuliser
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
Akita Jet Inhalation System
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of asthma or COPD.
* Male or female.
* Age between 18 to 75 years.
Exclusion Criteria
* Have an exacerbation of asthma or COPD within the 30 days prior to the first visit.
* Have a history or current evidence of an upper or lower respiratory infection, within the 30 days prior to the first visit.
* Have any other clinically significant medical disease or uncontrolled concomitant disease, that is likely, in the opinion of the investigators to impact on the ability to participate in the study.
18 Years
75 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Professor Tim W Harrison, MBBS, BSc, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Professor and Honorary Consultant, University of Nottingham
Locations
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Nottingham Respiratory Research Unit
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18010
Identifier Type: -
Identifier Source: org_study_id
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