Adherence by treatment group (ITT analysis)*
| 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).