Table 1. Study assessments in sub-group X and in sub-group M.
| Enrolment & start of the BlackBerry test period [Visit window (−2)] | Visit 1 Baseline [Visit window (0+2 weeks)] | Visit 2 [Visit window (52±2 weeks)] | Visit 3 h [Visit window (104±2 weeks)] | Extra Visits at the onset of a COPD exacerbation (COPD subjects in sub group X only)a | |
|---|---|---|---|---|---|
| BlackBerryb | C/Dc | Rc | Cc | ||
| EXACT-PRO + 3 additional questionsb |  |
||||
| MSCTb | x | x | x | ||
| Sputum collection for biomarkers and bacterial and viral analysisd | x | x | x | x | |
| Nasal swabs for bacterial and viral analysisb | x | x | x | x | |
| Throat swabs for bacterial and viral analysisb | x | x | x | x | |
| Blood for serum neutralising antibodiesb | x | xe | |||
| Biomarker blood sample B | x | x | |||
| Thigh muscle strengthf | x | x | xg | ||
| Dexa scan | x | x | xg | ||
a, Not performed during the BlackBerry test period; b, In subjects with COPD only; c, C, Check; D, Deliver; R, Return; d, Sputum was collected in all subjects including COPD and control subjects and processed for assessment of biomarkers. Bacteriology and virology was only conducted in samples from COPD subjects; e, Subjects were requested to return to the clinic 2 weeks later after the exacerbation visit for a further blood sample for assessment of neutralising antibodies to viruses and bacteria; f, Magnetic stimulation test of the thigh muscle; g, During the second year only; h, Subjects who withdrew from the study between enrolment and visit 3 were asked to return to the clinic and perform basic assessments for Visit 3. In addition they were requested to return their study equipment (such as BlackBerry device and note book). COPD, chronic obstructive pulmonary disease; MSCT, multi slice computerised tomography.