Sputum clearance devices to improve symptoms in chronic obstructive pulmonary disease

The O-COPD2 trial: oscillatory positive expiratory pressure devices to improve outcome in patients with chronic obstructive pulmonary disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18345305

Enrollment

102

Registered

2023-02-03

Start date

2023-07-01

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory

Interventions

Participants are randomly allocated to an Acapella group or to usual care. The Acapella group receive teaching on how to use an oscillatory positive expiratory pressure device (Acapella) device then t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with COPD who report daily sputum production and with a score of >5/8 on the two COPD assessment test (CAT) score cough items

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

Measure	Time frame
Cough-related quality of life measured using the Leicester cough questionnaire (LCQ) at 6 months	—

Secondary

Measure	Time frame
1. Cough severity measured by Visual Analog Scale (VAS) at 6 months 2. Health status measured by COPD Assessment Test (CAT) score at 6 months 3. Generic health status measured using EQ-5D-5L at 6 months 4. Fatigue measured using Functional Assessment of Chronic Illness Therapy (FACIT) score at 6 months 5. Exacerbation rate based on self-report at 6 months 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.	—

Measure

Time frame

1. Cough severity measured by Visual Analog Scale (VAS) at 6 months 2. Health status measured by COPD Assessment Test (CAT) score at 6 months 3. Generic health status measured using EQ-5D-5L at 6 months 4. Fatigue measured using Functional Assessment of Chronic Illness Therapy (FACIT) score at 6 months 5. Exacerbation rate based on self-report at 6 months 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.

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Countries

England, United Kingdom

Contacts

Public ContactAhmed Alzahrani

copd@rbht.nhs.uk+44 (0)2073518029

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026