Sputum clearance devices to improve symptoms in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN18345305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18345305 |
| IRAS number | 269494 |
| Secondary identifying numbers | IRAS 269494 V4, CPMS 43088 |
- Submission date
- 01/02/2023
- Registration date
- 03/02/2023
- Last edited
- 30/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims:
There are 1.3 million people with a diagnosis of chronic obstructive pulmonary disease (COPD) in the UK. COPD is a combination of chronic bronchitis (airway inflammation) and emphysema (damaged air sacs). Cough with sputum (mucus) is a common feature of the condition, even in people on optimum medical therapy. The amount of sputum production varies between individuals. Coughing can be tiring and embarrassing for patients. If sputum isn’t cleared, infections can arise. Sputum can also block small airways, meaning that the lungs can’t work effectively. The Acapella is a handheld device that patients can breathe into when they want to help clear sputum from their chest. It generates positive pressure which helps keep airways open and also produces vibrations which help to free sputum and make it easier to cough up. It is about the size of a small plastic water bottle and has a dial at the end to adjust the amount of resistance when the person breathes through it. There have been only a few short-term trials so far. These have been encouraging but do not provide enough evidence to recommend the widespread use of the devices. The aim of this study is to see if people with COPD who produce sputum daily benefit from using the Acapella to help them to clear sputum from their chest. This will involve measuring quality of life and also in some patients measuring how often they cough using a recording device.
Who can participate?
Adult patients with COPD who frequently produce sputum
What does the study involve?
Participants are randomly allocated to an Acapella group or to usual care. The Acapella group receive teaching on how to use the device then take it home (asked to use it at least three times daily). Both groups have measures of quality of life and severity of cough symptoms compared using well-established questionnaires at the beginning and after 6 months. A subset of patients will also be asked to wear a cough monitor and an activity monitor for 3 days.
What are the possible benefits and risks of participating?
Participants will be helping to advance the understanding of processes involved in lung disease. The sputum clearance device is already used in routine clinical practice, so apart from the inconvenience involved no risks are expected.
Where is the study run from?
Royal Brompton Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2022 to December 2025
Who is funding the study?
Saudi Arabia Cultural Bureau in London (UK)
Who is the main contact?
Nick Hopkinson, COPD@rbht.nhs.uk
Contact information
Principal Investigator
NHLI, Imperial College, London
Royal Brompton Hospital Campus
Fulham Road
London
SW3 6NP
United Kingdom
 ORCID ID |
0000-0003-3235-0454 |
|---|---|
| Phone | +44 (0)2073497775 |
| n.hopkinson@ic.ac.uk |
Public
NHLI, Imperial College London
Royal Brompton Hospital Campus
Fulham Rd
London
SW3 6NP
United Kingdom
| ORCID ID |
0000-0003-3200-5984 |
|---|---|
| Phone | +44 (0)2073518029 |
| copd@rbht.nhs.uk |
Scientific
NHLI, Imperial College, London
Royal Brompton Hospital Campus
Fulham Road
London
SW3 6NP
United Kingdom
| Phone | +44 (0)2073518029 |
|---|---|
| n.hopkinson@ic.ac.uk |
Study information
| Study design | Multi-centre single-blind randomized controlled parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use conmtact details to request a participant information sheet |
| Scientific title | The O-COPD2 trial: oscillatory positive expiratory pressure devices to improve outcome in patients with chronic obstructive pulmonary disease |
| Study acronym | O-COPD2 |
| Study hypothesis | In patients with chronic obstructive pulmonary disease (COPD), who produce sputum daily, does providing an oscillatory positive expiratory pressure (OPEP) device (the Acapella®) improve health status and reduce exacerbation frequency compared to usual care over 6 months? |
| Ethics approval(s) | Approved 09/08/2022, London-Chelsea Research Ethics Committee NRES (Research Ethics Committee [REC] London Centre, Skipton House, 80 London Road, London, SE1 6LH, UK; +44 (0)207 104 8029; nrescommittee.london-chelsea@nhs.net), ref: 19/LO/1427 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Participants are randomly allocated to an Acapella group or to usual care. The Acapella group receive teaching on how to use an oscillatory positive expiratory pressure device (Acapella) device then take it home (asked to use it at least three times daily). Both groups have measures of quality of life and severity of cough symptoms compared using well-established questionnaires at the beginning and after 6 months. A subset of patients will also be asked to wear a cough monitor and an activity monitor for 3 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Acapella device |
| Primary outcome measure | Cough-related quality of life measured using the Leicester cough questionnaire (LCQ) at 6 months |
| Secondary outcome measures | 1. Cough severity measured by Visual Analog Scale (VAS) at 6 months 2. Health status measured by COPD Assessment Test (CAT) score at 6 months 3. Generic health status measured using EQ-5D-5L at 6 months 4. Fatigue measured using Functional Assessment of Chronic Illness Therapy (FACIT) score at 6 months 5. Exacerbation rate based on self-report at 6 months A subset of 32 participants will undergo measurement of cough frequency and sleep movements to determine whether the OPEP device influences cough frequency and sleep efficiency. This will use the Leicester Cough Monitor and the McRoberts MoveMonitor at baseline and 12 weeks. |
| Overall study start date | 01/07/2022 |
| Overall study end date | 01/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 |
| Participant inclusion criteria | Adult patients with COPD who report daily sputum production and with a score of >5/8 on the two COPD assessment test (CAT) score cough items |
| Participant exclusion criteria | 1. Unable to provide informed consent 2. Major condition limiting life expectancy for 3 months 3. Referral for chest physiotherapy in the preceding year 4. Already using an adjunct device for sputum clearance 5. Within 1 month of pulmonary exacerbation 6. Within 1 month of COPD medication change 7. Within 1 month of a pneumothorax |
| Recruitment start date | 01/07/2023 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
SW3 6NP
United Kingdom
Sponsor information
University/education
Level 2
Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)2075949832 |
|---|---|
| cheuk-fung.wong@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk/research-and-innovation/support-for-staff/joint-research-office/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The results will be used to guide treatment guidelines for people with COPD and shared through presentation at conferences and publication in medical journals. No additional documents will be available. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
30/12/2024: The overall study end date was changed from 01/06/2025 to 01/12/2025.
19/07/2023: Note that an earlier study (ISRCTN44651852) is conducted under the same IRAS and ethics reference numbers. The reason for this is as follows: "The plan was originally to do a multicentre face to face study of Acapella devices. Because of COVID we adapted it to remote delivery from a single centre. Post-COVID we amended the ethics back to what we had originally intended to do (multicentre face to face delivery) and also made a few other alterations (inclusion now has to be sputum production daily, rather than daily or most days in the last week). As it is a different trial we have done a separate ISRCTN for O-COPD2 but it sits under the same ethical approval."
29/06/2023: The recruitment start date was changed from 01/05/2023 to 01/07/2023.
01/03/2023: Internal review.
02/02/2023: Trial's existence confirmed by the London-Chelsea Research Ethics Committee.
