Sputum clearance devices to improve symptoms in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN44651852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44651852 |
| IRAS number | 269494 |
| Secondary identifying numbers | 19IC5363; IRAS 269494 |
- Submission date
- 29/10/2019
- Registration date
- 30/10/2019
- Last edited
- 19/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 and emphysema. Cough with sputum 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 helps free sputum and makes 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 widespread use of the devices. The aim of this study is to see if people with COPD who produce sputum on at least most days of the week 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 3 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 3 months. A subset of patients also wears 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 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?
1. Royal Brompton and Harefield NHS Foundation Trust (UK)
2. Taunton and Somerset NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2019 to January 2022
Who is funding the study?
Saudi Arabia Cultural Bureau in London (UK)
Who is the main contact?
Saeed AlGhamdi
s.alghamdi18@imperial.ac.uk
Contact information
Public
Respiratory Muscle Lab
Royal Brompton Hosptal Campus
Fulham RD
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 73518029 |
|---|---|
| s.alghamdi18@imperial.ac.uk |
Scientific
Respiratory Muscle Lab
Royal Brompton Hosptal Campus
Fulham RD
London
SW3 6NP
United Kingdom
| Phone | +44 (0)2073518092 |
|---|---|
| s.alghamdi18@imperial.ac.uk |
Study information
| Study design | Multi-centre single-blind controlled parallel-group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | 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-COPD trial: oscillatory positive expiratory pressure (OPEP) devices to improve outcome in patients with chronic obstructive pulmonary disease (COPD) |
| Study acronym | O-COPD |
| Study hypothesis | In patients with chronic obstructive pulmonary disease (COPD), who produce sputum frequently (daily or most days in the preceding month), does providing an oscillatory positive expiratory pressure (OPEP) device (the Acapella®) improve health status and reduce exacerbation frequency compared to usual care over 3 months? |
| Ethics approval(s) | Approved 28/11/2019, 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 | COPD patients who produce sputum regularly |
| Intervention | Participants will be randomised to OPEP device (the AcapellaTM) with usual care or usual care alone. Allocation will be by computer-generated list. Active: Taught active cycle of breathing. Acapella device used at least three times per day Control: Taught active cycle of breathing The Acapella group will receive teaching on how to use the device then take it home (asked to use it at least three times daily). Both groups will have measures of quality of life (the main research outcome) and severity of cough symptoms compared using well-established questionnaires at the beginning and after 3 months. A subset of patients will also wear a cough monitor and an activity monitor for 3 days. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure | Cough symptoms measured using the Leicester cough questionnaire (LCQ) at baseline and 12 weeks |
| Secondary outcome measures | 1. Cough severity measured by Visual Analog Scale (VAS) at baseline and 12 weeks 2. Health status measured by CAT score at baseline and 12 weeks 3. Health status measured using EQ-5D-5L at baseline and 12 weeks 4. Fatigue measured using FACIT score at baseline and 12 weeks 5. Exacerbation rate (number of exacerbations during the 12 weeks of the study) measured using patient diaries at 12 weeks 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 | 13/01/2019 |
| Overall study end date | 14/01/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 |
| Total final enrolment | 103 |
| Participant inclusion criteria | Current participant inclusion criteria as of 02/03/2020: 1. Adult patients with COPD who frequently produce sputum defined as: (i) every or most days in the last month and a score of >=5/8 on the two CAT cough items 2. Stable treatment for the preceding four weeks Previous participant inclusion criteria: 1. Adult patients with COPD who frequently produce sputum defined as: (i) every or most days in the last month and a score of >=6/8 on the two CAT cough items 2. Stable treatment for the preceding four weeks |
| 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 | 27/02/2020 |
| Recruitment end date | 01/06/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SW3 6NP
United Kingdom
Taunton
TA1 5DA
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
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Royal Embassy of Saudi Arabia Cultural Bureau in London, Royal Embassy of Saudi Arabia - Cultural Bureau in London, Royal Embassy of Saudi Arabia Cultural Bureau, SACB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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? |
|---|---|---|---|---|---|
| Results article | 10/08/2022 | 12/08/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/07/2023: Note that a later study (ISRCTN18345305) 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."
12/08/2022: Publication reference added.
15/06/2022: Total final enrolment added.
14/06/2022: The intention to publish date was changed from 01/06/2022 to 30/09/2022.
27/07/2020: The ethics approval was added.
02/03/2020: The following changes have been made:
1. The recruitment start date has been changed from 01/12/2019 to 27/02/2020.
2. The participant inclusion criteria have been updated.
30/10/2019: Trial's existence confirmed by ethics committee.
