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Sputum clearance devices to improve symptoms in chronic obstructive pulmonary disease

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44651852
Enrollment
102
Registered
2019-10-30
Start date
2020-02-27
Completion date
Unknown
Last updated
2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD patients who produce sputum regularly Respiratory

Interventions

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 brea

Sponsors

Imperial College, London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cough symptoms measured using the Leicester cough questionnaire (LCQ) at baseline and 12 weeks

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactSaeed AlGhamdi
s.alghamdi18@imperial.ac.uk+44 (0)20 73518029

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026