Asthma, COPD
Conditions
Keywords
Asthma, COPD, Nebuliser, Sputum Induction, Safety, Tolerability, Quality, Quantity, Physiotherapy
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.
Interventions
DEVICEOmron NE-U17 Ultrasonic nebuliser
The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
DEVICEAkita Jet Inhalation System
The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
Sponsors
University of Nottingham
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Spirometry | During the visit, up to 4 hours | Measurement of lung function (FEV1 and FEV1%pred) |
| Saline quantity | During the visit, up to 30 minutes | The amount of sterile saline 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 |
| Time to produce sample | During the visit, up to 30 minutes | The time in minutes required to produce a sputum sample sufficient for processing |
Countries
United Kingdom
Contacts
Primary ContactDr Paula Almeida, PT, DHSc
Backup ContactKatherine M Smith, BA(Hons), MA
Outcome results
None listed