A Comparison of Two Nebulisers for Sputum Induction

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Asthma, COPD

Intervention / Treatment
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* Device: Omron NE-U17 Ultrasonic nebuliser
* Device: Akita Jet Inhalation System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Omron<br>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<br>* The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.<br>Device: Akita Jet Inhalation System<br>* The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.<br>|
| Active Comparator: Akita<br>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<br>* The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.<br>Device: Akita Jet Inhalation System<br>* The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity, Physiotherapy