A Comparison of Two Nebulisers for Sputum Induction

NCT ID: NCT04182009

Last Updated: 2019-12-02

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-12-31

Brief Summary

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Sputum induction is considered a relatively non-invasive, reliable procedure, which can be utilised to characterise the inflammatory profile of the airways.

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.

Detailed Description

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This is a single centre, crossover study to compare the use of two nebulisers in the sputum induction procedure. 54 participants with stable asthma or COPD will be recruited and will attend 2 visits, at least 48 hours apart. Differences in the quality and quantity of samples and the time taken to produce a sample will be described. The main purpose is to explore the optimum device to perform the procedure, whilst protecting the safety of participants and maximising their comfort.

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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Asthma COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type OTHER

Omron NE-U17 Ultrasonic nebuliser

Intervention Type DEVICE

The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.

Akita Jet Inhalation System

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Omron NE-U17 Ultrasonic nebuliser

Intervention Type DEVICE

The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.

Akita Jet Inhalation System

Intervention Type DEVICE

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.

Intervention Type DEVICE

Akita Jet Inhalation System

The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have an ability to provide fully informed consent.
* Have a diagnosis of asthma or COPD.
* Male or female.
* Age between 18 to 75 years.

Exclusion Criteria

* Have a post bronchodilator Forced Expiratory Volume in the first second of less than 1 litre or less than 50 percent of the predicted value.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr Paula Almeida, PT, DHSc

Role: CONTACT

0115 9691169 ext. 58012

Katherine M Smith, BA(Hons), MA

Role: CONTACT

0115 8231911

Facility Contacts

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Dr Paula Almeida, PT, DHSc

Role: primary

0115 9691169 ext. 58012

Katherine M Smith, BA(Hons), MA

Role: backup

0115 8231911

Other Identifiers

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18010

Identifier Type: -

Identifier Source: org_study_id

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