A Comparison of Two Nebulisers for Sputum Induction (FLAME)

University of Nottingham

Status: Unknown

Conditions: Asthma; COPD

Treatments: Device: Omron NE-U17 Ultrasonic nebuliser; Device: Akita Jet Inhalation System

Study type: Interventional

Funder types: Other

Identifiers

NCT04182009

18010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Omron

Other group

Description:

Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.

Treatment:

Device: Akita Jet Inhalation System

Device: Omron NE-U17 Ultrasonic nebuliser

Akita

Active Comparator group

Description:

Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.

Treatment:

Device: Akita Jet Inhalation System

Device: Omron NE-U17 Ultrasonic nebuliser