An interventional study of OPEP in COPD and Bronchiolitis, sponsored by Carwyn Bridges. Recruiting at 1 site in United Kingdom. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-25.
Sponsored by Carwyn Bridges · Not applicable, Interventional, and Treatment
Chronic Obstructive Pulmonary Disease (COPD) is a common preventable and treatable respiratory condition. Its main symptoms include, breathlessness, cough and frequent chest infections. Many people with COPD struggle with excessive production of sputum, resulting in more hospital admissions and worse symptoms affecting quality of life.
Guidelines suggest techniques to help clear sputum but there is not strong evidence behind these. In particular we don't know how effective cough clearance techniques are and indeed if any are better than others. This study will recruit people admitted to hospital with an exacerbation of COPD who have excessive sputum and randomise them to receive a hand-held airways clearance device or chest physiotherapy exercises. We will compare symptoms, quality of life, treatment burden and hospital admissions over the following year.
Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable and treatable disease and in the UK around 80% is caused by smoking. Respiratory symptoms include breathlessness, cough and excess sputum production. COPD is associated with significant healthcare burden and increased mortality and morbidity (GOLD, 2020).
Exacerbations are acute periods of worsening symptoms above normal day to day variation, leading to increased treatment and often emergency hospital admissions placing a significant burden on the health care system and are associated with a worse QoL and poorer long-term prognosis. (Ekberg-Aronsson et al., 2005). COPD causes over 30,000 deaths in the UK annually, and is the second commonest cause of hospital admission (NICE, 2018).
Patients with a chronic bronchitis phenotype have worse health status and COPD Assessment Test (CAT) score, experience more frequent exacerbations and received more pharmacological treatment than other phenotypes (Cosio et al., 2016).
Airways clearance appears an important adjunctive treatment in those with a chronic bronchitis phenotype of COPD who struggle with mucus hypersecretion (Svenningsen et al., 2016) but the evidence is not strong. In particular there are no well-designed studies (Randomised control trials-RCT's) that compare different types of cough clearance techniques against medication alone or against each other.
Burudpakdee et al. (2017) in a retrospective Canadian database analysis enrolled 405 participants into two crossmatch groups over a two-year period, found that provision of Oscillatory Positive Expiratory Pressure (OPEP) Aerobika™ devices were associated with a 19% re-exacerbation rate, compared with a 28% exacerbation rate in those receiving standard care (p=0.01). They suggested Aerobika™ may be a cost-effective way of reducing emergency department visits and costs associated with unplanned admissions. However, as this was a retrospective study, the data used to make these assumptions may lack clinical detail and be prone to reporting and selection bias.
The physiological rational for the use of AerobikaTM is demonstrated in Svenningsen et al. (2016) in a randomised crossover study. Regular use of Aerobika™ improved ventilation through sputum mobilisation which seemed to have a positive effect on QoL, ease of expectoration and pulmonary function -Forced Vital Capacity (FVC).
Several studies including Khoudigian-Sinani et al. (2017) and Thanh et al. (2019) analysed the cost effectiveness of the provision of an Aerobika™ in the United States and Canada respectively. Both studies concluded that Aerobika™ provided good value for money in reducing healthcare costs.
NICE (2018) guidelines state:
"If people have excessive sputum, they should be taught how to use positive expiratory pressure devices or active cycle of breathing techniques".
Despite a paucity of evidence NICE (2018) regard both OPEP (Aerobika™) and Active Cycle of Breathing Techniques (ACBT) as standard care in those people with COPD with excessive secretions. The reality in clinical care is that ACBT forms the first line treatment option with OPEP AerobikaTM offered as second line due to funding. There is a lack of evidence to support this decision making.
OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS Rationale This study aims to provide some more robust information to inform clinicians of the effectiveness and tolerability of ACBT or OPEP (AerobikaTM) as part of an airway's clearance regime, in people with COPD and a chronic bronchitis phenotype.
5.2. Aims and Objectives A feasibility Randomised Control Trial (RCT) including real world evidence to assess the outcomes of OPEP (AerobikaTM) for people with COPD with a chronic bronchitis phenotype Primary Objectives
Secondary Objectives
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Carwyn Bridges as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oscillatory Positive Expiratory Pressure OPEP is a technique aimed at loosening and mobilising secretions it can be achieved by using a device (AerobikaTM). The device provides pulses of resistance as you exhale acting to open airways and shake secretions, enabling expectoration using a huff and cough technique. Key factors to consider when completing a treatment session are body position, users should be seated, with good posture, in a comfortable position.
Device: OPEP
Active Cycle of Breathing Technique ACBT is a method of breathing performed in a cycle, used to help loosen and clear secretions from within the lungs (Panaligan et al., 2012). It consists of three different phases.
Device: OPEP
OPEP (Aerobika (tm)
Also known as: ACBT
To test the null hypothesis there is no difference in Leister Cough Questionnaire between groups at 3 months
LCQ is a validated cough questionnaire. It consists of a 19-part questionnaire with a Likert scale scoring system between 1-7 measurements of physical, psychological, and social domains.
Time frame: 3 months
To test the null hypothesis there is no difference in CAT between groups at 3 months
The CAT outcome measure is used in COPD research. Gupta et al. (2014) report good internal consistency (0.88-0.98), validity (p=\>0.05) and responsiveness within exacerbations increasing scores by 4-5 points and rehabilitation decreasing scores by 2-3. we will measure the numerical change in score
Time frame: 3 months
Plan to share: No
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Pulmonary Disease, Chronic Obstructive →