Condition category
Respiratory
Date applied
29/10/2019
Date assigned
30/10/2019
Last edited
30/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Mr Saeed AlGhamdi

ORCID ID

Contact details

Respiratory Muscle Lab
Royal Brompton Hosptal Campus
Fulham RD
London
SW3 6NP
United Kingdom
+44 (0)20 73518029
s.alghamdi18@imperial.ac.uk

Type

Scientific

Additional contact

Mr Saeed AlGhamdi

ORCID ID

Contact details

Respiratory Muscle Lab
Royal Brompton Hosptal Campus
Fulham RD
London
SW3 6NP
United Kingdom
+44 (0)2073518092
s.alghamdi18@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

19IC5363; IRAS: 269494

Study information

Scientific title

The O-COPD trial: oscillatory positive expiratory pressure (OPEP) devices to improve outcome in patients with chronic obstructive pulmonary disease (COPD)

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

Approval pending, London-Chelsea Research Ethics Committee NRES (Research Ethics Committee (REC) London Centre, Skipton House, 80 London Road, London, SE1 6LH, UK; Tel: +44 (0)207 104 8029; Email: nrescommittee.london-chelsea@nhs.net), IRAS Project ID: 269494

Study design

Multi-centre single-blind controlled parallel-group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use conmtact details to request a participant information sheet.

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

Phase

Phase III

Drug names

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 trial start date

13/01/2019

Overall trial end date

14/01/2022

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

102

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

01/12/2019

Recruitment end date

01/06/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton and Harefield NHS Foundation Trust
Fulham Rd
London
SW3 6NP
United Kingdom

Trial participating centre

Taunton and Somerset NHS Foundation Trust
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Sponsor information

Organisation

Imperial College, London

Sponsor details

Level 2
Medical School Building
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)2075949832
cheuk-fung.wong@imperial.ac.uk

Sponsor type

University/education

Website

https://www.imperial.ac.uk/research-and-innovation/support-for-staff/joint-research-office/

Funders

Funder type

Other

Funder name

Saudi Arabia Cultural Bureau in London

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

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit

Location

United Kingdom

Results and Publications

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 statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/06/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

30/10/2019: Trial's existence confirmed by ethics committee.