Change in the SOBDA (A) weekly score by PGAC responders, and (B)last treatment week score by assessment responders at visit 3
(A) | ||||||
---|---|---|---|---|---|---|
Day 8 | Day 15 | Day 22 | Day 29 | Day 36 | Day 43 | |
PGAC responders (n) | 105 | 91 | 83 | 62 | 77 | 31 |
PGAC non-responders (n) | 188 | 212 | 216 | 223 | 200 | 88 |
LS mean difference in SOBDA scores between groups (95% CI) | 0.24 (0.18 to 0.31) | 0.12 (0.06 to 0.19) | 0.11 (0.06 to 0.16) | 0.11 (0.06 to 0.17) | 0.13 (0.08 to 0.18) | 0.06 (−0.03 to 0.15) |
p Value* | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | NS |
(B) | |||||
---|---|---|---|---|---|
CGI-C | CRQ-SAS dyspnoea domain | Clinician-completed mMRC | Patient-completed mMRC | PGAC | |
Responders (n) | 120 | 117 | 91 | 92 | 45 |
Non-responders (n) | 181 | 184 | 210 | 209 | 106 |
LS mean difference in SOBDA scores between groups (95% CI) | 0.24 (0.14 to 0.34) | 0.30 (0.21 to 0.40) | 0.03 (–0.08 to 0.15) | 0.08 (–0.02 to 0.19) | 0.08 (–0.07 to 0.23) |
p Value† | <0.001 | <0.001 | NS | NS | NS |
*Comparison of SOBDA scores (non-responders minus responders) based on analysis of covariance adjusted for age, gender and previous week's SOBDA score.
†Comparison of SOBDA scores (non-responders minus responders) based on Analysis of Covariance adjusted for age, gender and baseline SOBDA weekly score.
CGI-C, Clinician Global Impression of Change; CRQ-SAS, Chronic Respiratory Disease Questionnaire self-administered standardised version; LS, least squares; mMRC, modified Medical Research Council; NS, not significant; PGAC, Patient Global Assessment of Change; SOBDA, Shortness of Breath with Daily Activities.