Comparing two methods for clearing mucus in COPD patients
A Feasibility Randomised Control Trial (RCT) of Aerobika TM Verses Active Cycle of Breathing Technique (ACBT) in People With Chronic Obstructive Pulmonary Disease (COPD)
NA · Hywel Dda Health Board · NCT05548036
This study is testing whether a new hand-held device or traditional chest exercises work better to help COPD patients clear mucus and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Hywel Dda Health Board (other) |
| Locations | 1 site (Cardiff, Wales) |
| Trial ID | NCT05548036 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a hand-held airways clearance device (OPEP) versus traditional chest physiotherapy exercises in patients with Chronic Obstructive Pulmonary Disease (COPD) who are experiencing excessive sputum production. Participants will be recruited from hospitals during exacerbations of COPD and will be randomized to receive one of the two interventions. The study will assess various outcomes including symptoms, quality of life, treatment burden, and hospital admissions over the course of one year. The goal is to determine which method is more effective in managing sputum clearance and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40-90 with a diagnosis of COPD, experiencing regular sputum production and currently admitted to the hospital or recently treated for an exacerbation.
Not a fit: Patients with contraindications to the OPEP device, unstable cardiac conditions, or a life expectancy of less than 12 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for managing sputum clearance in COPD patients, potentially reducing hospital admissions and improving quality of life.
How similar studies have performed: While there is limited strong evidence supporting the effectiveness of cough clearance techniques, this study aims to fill a gap in the literature by directly comparing two methods in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted to hospital (current inpatient) or recent exacerbation treated in the community within 14 days with systemic steroids and/or antibiotics * Male or Female, aged 40-90 years * A diagnosis of COPD * Greater than 10 pack year history * FEV1 /FVC Ratio \<0.70 at any time point in the last 5 years * Regular sputum production (most days for at least 3 months) * Prescribed optimal pharmacological treatment * Able to provide informed consent * CAT score \>15 Exclusion Criteria: * Contraindications to OPEP, recent hemoptysis or pneumothorax * Unable to use OPEP (manual dexterity) * Unstable cardiac conditions in the opinion of the clinical team * Life expectancy less than 12 months.
Where this trial is running
Cardiff, Wales
- Mr Carwyn Bridges — Cardiff, Wales, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Carwyn G Bridges, PI
- Email: carwyn.bridges2@wales.nhs.uk
- Phone: 02921826841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COPD, Bronchiolitis, airways clearance