A Comparison of Two Nebulisers for Sputum Induction

Asthma Clinical Trial

— FLAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04182009
• Other study ID #: 18010
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: University of Nottingham
• Contact: Dr Paula Almeida, PT, DHSc
• Phone: 0115 9691169
• Email: paula.almeida[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	Nottingham Respiratory Research Unit	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spirometry	Measurement of lung function (FEV1 and FEV1%pred)	During the visit, up to 4 hours
Secondary	Borg Scale	Measurement of dyspnoea levels	During the visit, up to 4 hours
Secondary	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
Secondary	The quantity of sputum samples	How much sputum sample was produced of sufficient quality for processing	During the visit, up to 4 hours
Secondary	Time to produce sample	The time in minutes required to produce a sputum sample sufficient for processing	During the visit, up to 30 minutes
Secondary	Saline quantity	The amount of sterile saline required to produce a sputum sample sufficient for processing	During the visit, up to 30 minutes
Secondary	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