Clinical trial NCT04182009: A Comparison of Two Nebulisers for Sputum Induction
Official title: A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
COPD
Keywords: Asthma
COPD
Nebuliser
Sputum Induction
Safety
Tolerability
Quality
Quantity
Physiotherapy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-12-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The tolerability to sputum induction test
timeFrame: During the visit, after each cycle of nebulisation (each 5 minutes)
Secondary outcomes:
measure: Spirometry
timeFrame: During the visit, up to 4 hours
measure: Borg Scale
timeFrame: During the visit, up to 4 hours
measure: The quality of sputum samples
timeFrame: During the processing time, 2 hours
measure: The quantity of sputum samples
timeFrame: During the visit, up to 4 hours
measure: Time to produce sample
timeFrame: During the visit, up to 30 minutes
measure: Saline quantity
timeFrame: During the visit, up to 30 minutes
measure: Influence of Physiotherapy techniques
timeFrame: During the study visit, up to 5 minutes
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Respiratory Research Unit
Study officials:
affiliation: Professor and Honorary Consultant, University of Nottingham
name: Professor Tim W Harrison, MBBS, BSc, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: