Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
Bacillus Calmette–Guérin (BCG) vaccine. Participants need to get Interferon-Gamma Release Assay (IGRA) to test their TB status and only those who are negative will be eligible for the trial.
Eligible
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any adult (age =18 years) patient with primary clinical diagnosis of COPD who has had =2 exacerbations in the last 12 months
Exclusion criteria
Exclusion criteria: 1. Positive IGRA at enrolment 2. Known pregnancy 3. Immunosuppressed in the opinion of the investigator (including, but not restricted to: Human immunodeficiency viral (HIV) infection, common variable immunodeficiency, chemotherapy, disease modifying agents for rheumatic diseases), 4. Anyone who has had >20mg prednisolone for >14 days in the last 3 months 5. previous experience of allergic reaction to vaccine 6. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of moderate to severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) (number per person per year) over 12 months follow up from BCG administration date (or from the date of randomisation if no treatment was administered), measured using Participant Reported Outcomes (Questionnaires) at the time of exacerbation, 3- and 12-month follow up. In addition to lab results whenever they experience an exacerbation and a 12-month follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hospitalisation rate for infective exacerbation at 12 months, measured using patient-completed exacerbation form and 3- and 12-month follow-up questionnaires 2. Quality of life (QOL) measured using the COPD Assessment Test (CAT) at 12 months 3. Total number of days of antibiotic therapy, whether for respiratory or other causes, at 12 months, measured using Participant Reported Outcomes (Questionnaires) at the time of exacerbation and 12-month follow-up 4. Total number of days of oral steroid therapy for exacerbations at 12 months, measured using Participant Reported Outcomes (Questionnaires) at the time of exacerbation and 12-month follow-up 5. Type of exacerbation (as they occur [rate over time]) defined by Anthonisen criteria defined by clinical adjudication committee (CAD) who will be meeting every 3 months to assess all the exacerbation-related forms, reports, and lab results 6. Host immune response measured using viral throat swab (PCR) and bacterial culture of sputum at the time of exacerbation | — |
Countries
United Kingdom
Outcome results
None listed