COPD patients who produce sputum regularly Respiratory
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Cough symptoms measured using the Leicester cough questionnaire (LCQ) at baseline and 12 weeks | — |
Secondary
| Measure | Time 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