Overview of study assessments performed at the scheduled monthly visits and at exacerbation visits
| Description | Frequency of assessment* |
|---|---|
| Clinical variables | |
| Physical examination | Monthly and within 72 h of onset of exacerbation |
| Anthropometrics and nutritional screening (MUST)† | Quarterly |
| Intercurrent comorbidities | Monthly and within 72 h of onset of exacerbation |
| Medical history/medical record review | Study entry and within 72 h of onset of exacerbation |
| Vaccination history | Annually |
| Current medication | Monthly |
| Smoking status | Monthly |
| Urine pregnancy test | Study entry, final visit and within 72 h of onset of exacerbation |
| Chest CT scan | Study entry and final visit |
| Chest X-ray | Within 72 h of onset of exacerbation |
| Lung function testing | |
| Body box | Study entry and final visit |
| TLCO‡ | Every 6 months and within 72 h of onset of exacerbation |
| Spirometry | Monthly and within 72 h of onset of exacerbation |
| 6 min walk test | Every 6 months |
| Questionnaires and patient-reported outcome instruments | |
| ATS-DLD-78A (risk factors, disease history and smoking history) | Study entry |
| Healthcare use§ | Monthly and within 72 h of onset of exacerbation |
| mMRC¶ | Every 6 months |
| CAT questionnaire** | Quarterly and within 72 h of onset of exacerbation |
| EQ-5D index and VAS†† | Quarterly and within 72 h of onset of exacerbation |
| NEADL‡‡ | Quarterly and within 72 h of onset of exacerbation |
| CNAQ§§ | Quarterly and within 72 h of onset of exacerbation |
| Biological specimen collection | |
| Blood sampling | |
| For routine biochemistry | Study entry |
| For cell-mediated immune response | Quarterly and within 72 h of onset of exacerbation |
| For biomarkers, blood counts and haematology | Quarterly and within 72 h of onset of exacerbation |
| For RNA transcript profiling | Every 6 months and within 72 h of onset of exacerbation |
| For vitamins, antioxidants and nutrients (20 mL) | Every 6 months and within 72 h of onset of exacerbation |
| Nasopharyngeal swab sampling¶¶ | Monthly and within 72 h of onset of exacerbation |
| Sputum sampling | Monthly and within 72 h of onset of exacerbation |
| Breath sampling*** | Monthly and within 72 h of onset of exacerbation |
| Urine sampling††† | Monthly and within 72 h of onset of exacerbation |
*In addition to study entry.
†Height, weight, mid-arm circumference, waist circumference, triceps skin-fold measurement, fat-free body mass.
‡TLCO: transfer factor.
§Healthcare use includes medication, vaccination, oxygen therapy, use of mechanical ventilation, pulmonary rehabilitation treatment, surgical intervention, outpatient visits (including GP visit contacts to COPD team), emergency room visits, hospitalisations and productivity loss (time missed from work or usual activities due to worsening of COPD symptoms).
¶mMRC: Medical Research Council Dyspnea Scale score.
**CAT: COPD Assessment Test.
††VAS: visual analogue scale.
‡‡NEADL: Nottingham Extended Activities of Daily Living Scale.
§§CNAQ: Council on Nutrition Appetite Questionnaire.
¶¶In all participants at study entry and in a subcohort of 30 participants during the first year.
***In a subcohort of approximately 80 participants.
†††In all participants at study entry and within 72 h of every exacerbation and in the subcohort of 30 participants providing nasopharyngeal swabs during the first year of the study.
COPD, chronic obstructive pulmonary disease; GP, general practitioner; MUST, Malnutrition Universal Screening Tool.