Trials / Unknown
UnknownNCT04182009
A Comparison of Two Nebulisers for Sputum Induction
A Comparison of Two Nebulisers for Performing Sputum Induction to Assess Airway Inflammation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- University of Nottingham · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Omron NE-U17 Ultrasonic nebuliser | The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled. |
| DEVICE | Akita Jet Inhalation System | The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure. |
Timeline
- Start date
- 2018-09-17
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2019-12-02
- Last updated
- 2019-12-02
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT04182009. Inclusion in this directory is not an endorsement.