FF/VI (n=1396) | UC (n=1403) | |||
---|---|---|---|---|
PDC^{†} n Mean (SD),% <80%, n (%) ≥80%, n (%) | 1378 84.99 (22.29) 346 (25) 1032 (75) | 1361 82.40 (23.11) 447 (33) 914 (67) | ||
MARS-A 9 score Baseline (randomisation) n Mean (SD) Study end^{¶} n Mean (SD) Difference (baseline → study end^{¶}) n Mean (SD) | 1393 4.42 (0.677) 1318 4.61 (0.563) 1315 0.20 (0.730) | 1402 4.44 (0.666) 1324 4.44 (0.664) 1324 0.00 (0.750) | ||
Outcomes in patients with PDC < 80% and ≥ 80 % by treatment arm (ITT analysis)^{*†} |
PDC<
80%
(n=793) |
PDC≥80
%
(n=1946) | ||
FF/VI
(n=346) |
UC
(n=447) |
FF/VI
(n=1032) |
UC
(n=914) | |
LS mean annual rate of moderate/severe exacerbations, n (PEA population)^{‡} | n=282 1.68 | n=364 1.87 | n=839 1.77 | n=738 1.93 |
Rate ratio (95% CI) | 0.90 (0.78–1.04) | 0.92 (0.84–1.01) | ||
HRU | ||||
LS mean COPD-related primary care contacts, n | 2.13 | 2.46 | 2.51 | 2.45 |
Rate ratio (95% CI) | 0.87 (0.76–0.98) | 1.03 (0.95–1.11) | ||
LS mean COPD-related secondary care contacts, n | 1.31 | 1.24 | 1.64 | 1.53 |
Rate ratio (95% CI) | 1.06 (0.75–1.49) | 1.07 (0.87–1.33) | ||
CAT score^{§} n Baseline score, mean (SD) n at endpoint Responder, n (%) Non-responder, n (%) | 345 22.9 (9.10) 312 133 (43) 179 (57) | 447 22.4 (9.02) 415 165 (40) 250 (60) | 1031 21.1 (8.78) 990 456 (46) 534 (54) | 913 21.6 (8.57) 876 304 (35) 572 (65) |
Adjusted odds ratio (95% CI) | 1.07 (0.78–1.46) | 1.71 (1.40–2.07) |
CAT, COPD Assessment Test; CI, confidence interval; HRU, healthcare resource utilisation; ITT, intent-to-treat; LS, least squares; MARS-A 9; Medication Adherence Report Scale for Asthma (modified for use in COPD, 9-item questionnaire used [omitting score for Question ‘Before doing something’]; higher MARS-A 9 scores indicate better adherence); PEA, primary effectiveness analysis; SD, standard deviation. ^{*}Based on a total of 2739 patients in the ITT population with available treatment adherence data, unless otherwise stated. ^{†}PDC determined at study end, using all prescriptions during the study treatment period. ^{¶}Based on last available MARS-A 9 measurement post-randomisation. ^{‡}Based on a total of 2223 patients in the PEA population with available treatment adherence data. ^{§}Post-hoc summary/analysis of CAT data by PDC category; all other summaries/analyses were pre-specified. CAT responder is defined as a change from baseline of ≤ –2 at endpoint (last available on-treatment measurement).