TABLE 3.
Impact of 24-week CID status on 52-week outcomes (EXT population)
| Outcome measure | CID- subgroup | CID+ subgroup |
| Subjects n | 152 | 260 |
| Trough FEV1 mL | ||
| Baseline | 129 | 223 |
| Mean±sd | 1421±536 | 1356±575 |
| Change from baseline at week 52 | 129 | 223 |
| Mean±sd | 169±242 | −31±245 |
| SGRQ total score# | ||
| Baseline n | 152 | 259 |
| Mean±sd | 55.4±15.9 | 49.8±15.2 |
| Change from baseline at week 52 n | 130 | 223 |
| Mean±sd | −10.1±14.1 | 1.2±14.1 |
| CAT# | ||
| Baseline | 151 | 258 |
| Mean±sd | 19.1±6.6 | 17.2±5.5 |
| Change from baseline at week 52 | 129 | 222 |
| Mean±sd | −3.6±6.4 | −0.2±5.8 |
| E-RS:COPD# | ||
| Baseline n | 151 | 258 |
| Mean±sd | 14.20±5.55 | 12.88±5.46 |
| Change from baseline at week 52 | 130 | 223 |
| Mean±sd | −3.14±5.65 | −0.83±5.17 |
| Incidence of moderate/severe COPD exacerbations¶ | 19 (13) | 38 (15) |
Data are presented as n or n (%), unless otherwise stated. CID: clinically important deterioration; EXT: extension; FEV1: forced expiratory volume in 1 s; SGRQ: St George's Respiratory Questionnaire; COPD: chronic obstructive pulmonary disease; CAT: COPD assessment test; E-RS:COPD: Evaluating Respiratory Symptoms in COPD. #: a decrease in score represents an improvement in symptoms. ¶: incidence assessed post-CID assessment during weeks 25 to 52. The CID- subgroup included patients who had not experienced a CID at 24 weeks; the CID+ subgroup included patients who had experienced a CID at 24 weeks.