The O-COPD trial: OPEP devices in COPD
Research type
Research Study
Full title
The O-COPD trial: Oscillatory Positive Expiratory Pressure (OPEP) devices to improve outcome in patients with Chronic Obstructive Pulmonary Disease (COPD)
IRAS ID
269494
Contact name
Nicholas Hopkinson
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 7 months, 31 days
Research summary
Research 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. We want to see if people with COPD who produce sputum on at least most days of the week benefit from using a device called an Acapella to help them to clear sputum from their chest. This will involve looking at measures of quality of life and also in some patients we will measure how often they cough using a recording device.
Background: 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 a positive pressure which helps keep airways open and also produces vibration which helps 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 widespread use of the devices.
Design and methods: 102 people with COPD will be recruited from hospital and community clinics into a randomised controlled trial. Half will be randomly allocated to an “Acapella” group and half to “usual care”. The Acapella group will receive teaching on how to use the device then take it home (asked to use it at least 3 times daily). Both groups will have measures of quality of life (our 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.
Dissemination: The results will be used to guide treatment guidelines for people with COPD and shared through presentation at conferences and publication in medical journals.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1427
Date of REC Opinion
2 Dec 2019
REC opinion
Further Information Favourable Opinion