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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omron | Other | Omron group will undergo sputum induction with the Omron nebuliser at Visit 1, followed by the Akita Jet nebuliser at Visit 2. |
|
| Akita | Active Comparator | Akita group will undergo sputum induction with the Akita Jet nebuliser at Visit 1, followed by the Omron nebuliser at Visit 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omron NE-U17 Ultrasonic nebuliser | Device | The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Paula Almeida, PT, DHSc | Contact | 0115 9691169 | 58012 | paula.almeida@nottingham.ac.uk |
| Katherine M Smith, BA(Hons), MA | Contact | 0115 8231911 | katherine.m.smith@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Professor Tim W Harrison, MBBS, BSc, MD, MSc | Professor and Honorary Consultant, University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Respiratory Research Unit | Recruiting | Nottingham | NG5 1PB | United Kingdom |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Akita Jet Inhalation System | Device | The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure. |
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |