A Comparison of Two Nebulisers for Sputum Induction

Not Applicable

• Conditions: Asthma; COPD
• Interventions: Device: Omron NE-U17 Ultrasonic nebuliser; Device: Akita Jet Inhalation System

• Registration Number: NCT04182009
• Lead Sponsor: University of Nottingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-17
• Status Verified: 2019-06
• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-12-02
• Last Update Posted: 2019-12-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omron	Omron NE-U17 Ultrasonic nebuliser	Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.
Akita	Akita Jet Inhalation System	Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
Akita	Omron NE-U17 Ultrasonic nebuliser	Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.
Omron	Akita Jet Inhalation System	Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.

Primary Outcome Measures

Name	Time	Method
The tolerability to sputum induction test	During the visit, after each cycle of nebulisation (each 5 minutes)	Checking discomfort degree due to inhalation of hypertonic saline assessed by a visual analogue scale (0 to 10)

Secondary Outcome Measures

Name	Time	Method
Saline quantity	During the visit, up to 30 minutes	The amount of sterile saline required to produce a sputum sample sufficient for processing
Spirometry	During the visit, up to 4 hours	Measurement of lung function (FEV1 and FEV1%pred)
Borg Scale	During the visit, up to 4 hours	Measurement of dyspnoea levels
The quality of sputum samples	During the processing time, 2 hours	The analysis of squamous contamination in the sample (if \>40%), viability (\>65% of life cells) and quality of slide for differential cells count
The quantity of sputum samples	During the visit, up to 4 hours	How much sputum sample was produced of sufficient quality for processing
Time to produce sample	During the visit, up to 30 minutes	The time in minutes required to produce a sputum sample sufficient for processing
Influence of Physiotherapy techniques	During the study visit, up to 5 minutes	The influence of manual vibrations and Huff cough in producing a sputum sample after unsuccessful induction attempts

Trial Locations

Locations (1)

Nottingham Respiratory Research Unit; 🇬🇧 Nottingham, United Kingdom