Sputum clearance devices to improve symptoms in chronic obstructive pulmonary disease

Phase 4

• Conditions: Respiratory; Chronic obstructive pulmonary disease (COPD)

• Registration Number: ISRCTN18345305
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-03
• Last Update Posted: 2 August 2023
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cough-related quality of life measured using the Leicester cough questionnaire (LCQ) at 6 months

Secondary Outcome Measures

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