A Comparison of Two Nebulisers for Sputum Induction (FLAME)

A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation

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.

Study Overview

• Status: Unknown
• Conditions: Asthma; COPD
• Intervention / Treatment: Device: Omron NE-U17 Ultrasonic nebuliser; Device: Akita Jet Inhalation System

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 Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Recruiting
    • Nottingham Respiratory Research Unit
    • Contact: Dr Paula Almeida, PT, DHSc; Phone Number: 58012 0115 9691169; Email: paula.almeida@nottingham.ac.uk
    • Contact: Katherine M Smith, BA(Hons), MA; Phone Number: 0115 8231911; Email: katherine.m.smith@nottingham.ac.uk
    • Principal Investigator: Professor Tim W Harrison, MBBS, MD,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Omron; Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2.	Device: Omron NE-U17 Ultrasonic nebuliser; The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.; Device: Akita Jet Inhalation System; The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Active Comparator: Akita; Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2.	Device: Omron NE-U17 Ultrasonic nebuliser; The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.; Device: Akita Jet Inhalation System; The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Professor Tim W Harrison, MBBS, BSc, MD, MSc, Professor and Honorary Consultant, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Asthma; COPD; Physiotherapy; Tolerability; Quality; Nebuliser; Sputum Induction; Quantity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 18010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No