Table 2.
Efficacy Outcomes.
| Measure | EDS-placebo BID n = 82 | EDS-FLU 93 µg BID n = 81 | EDS-FLU 186 µg BID n = 80 | EDS-FLU 372 µg BID n = 79 | ||
|---|---|---|---|---|---|---|
| Nasal symptoms, LS mean change from baseline (SE) | ||||||
| Coprimary end pointa | ||||||
| Congestion/obstruction, week 4 | −0.24 (0.07) | −0.49 (0.08) | −0.54 (0.08) | −0.62 (0.08) | ||
| Difference, active-placebo (95% CI) | − | −0.43, −0.06 | −0.48, −0.11 | −0.57, −0.19 | ||
| P value versus EDS-placebo | .010 | .002 | <.001 | |||
| Secondary outcomes | n = 77 | n = 78 | n = 79 | n = 78 | ||
| Congestion/obstruction, week 4 | −0.26 (0.08) | −0.51 (0.08)** | −0.55 (0.08)** | −0.64 (0.08)* | ||
| Rhinorrhea, week 4 | −0.23 (0.09) | −0.48 (0.09)** | −0.55 (0.08)** | −0.55 (0.08)** | ||
| Facial pain and pressure, week 4 | −0.18 (0.08) | −0.35 (0.08) | −0.43 (0.08)** | −0.39 (0.08)** | ||
| Smell, week 4 | −0.04 (0.08) | −0.23 (0.08)** | −0.21 (0.08) | −0.33 (0.08)** | ||
| Objective assessments of nasal polyps | n = 82 | n = 81 | n = 80 | n = 79 | ||
| Coprimary end pointa | ||||||
| Total polyp grade, LS mean change (SE), week 16 | −0.45 (0.14) | −0.96 (0.14) | −1.03 (0.14) | −1.06 (0.14) | ||
| Difference, active-placebo (95% CI) | − | −0.86, −0.16 | −0.93, −0.24 | −0.96, −0.27 | ||
| P value versus EDS-placebo | − | .004 | <.001 | <.001 | ||
| Secondary outcomes | ||||||
| Total polyp grade, LS mean change (SE) | Week 24b (EDS-FLU 372 µg) | −1.08 (0.15) | −1.40 (0.15) | −1.39 (0.15) | −1.43 (0.14) | |
| ≥1-point improvement n/N (%) | Week 16 | 28/68 (41.2) | 42/75 (56.0) [OR = 1.921] |
45/68 (66.2)** [OR = 3.017] |
54/75 (72.0)* [OR = 2.783] |
|
| Week 24 (EDS-FLU 372 µg)b 6 µ | 47/64 (73.4) | 50/70 (71.4) [OR = 0.966] |
48/64 (75.0) [OR = 1.112] |
53/71 (74.6) [OR = 1.144] |
||
| Polyp elimination n/N (%) | Week 16 | 9/68 (13.2) | 19/75 (25.3) [OR = 2.343] |
12/68 (17.6) [OR = 1.518] |
14/75 (18.7) [OR = 1.485] |
|
| Week 24 (EDS-FLU 372 µg)b | 17/64 (26.6) | 24/70 (34.3) [OR = 1.537] |
16/64 (25.0) [OR = 0.978] |
19/71 (26.8) [OR = 1.007] |
||
| Patient reported outcome measures | ||||||
| Key secondary end pointsa | ||||||
| SNOT-22, LS mean change (SE) | Week 16 | −10.96 (2.07) | −18.32 (2.05)* | −19.56 (2.04)* | −19.80 (2.05)* | |
| Week 24 (EDS-FLU 372 µg)b | −20.78 (2.11) | −21.20 (2.07) | −23.28 (2.08) | −21.72 (2.07) | ||
| MOS Sleep-R Sleep Problems Index, LS mean change (SE) | Week 16 | −8.53 (1.61) | −10.69 (1.59) | −14.24 (1.59)** | −10.66 (1.55) | |
| Other secondary end points | ||||||
| PGIC, much improved or very much improved, n/N (%) | Week 16 | 28/68 (41.2) | 45/73 (61.6)** [OR = 0.508] |
47/70 (67.1)* [OR = 0.290] |
50/75 (66.7)* [OR = 0.367] |
|
| Week 24 (EDS-FLU 372 µg)b | 52/64 (81.3) | 44/70 (62.9) [OR = 1.365] |
52/64 (81.3) [OR = 0.640] |
55/71 (77.5) [OR = 1.211] |
||
| RSDI Total Score, LS mean change (SE) | Week 16 | −10.71 (2.07) | −17.08 (1.99)** | −16.44 (2.02)** | −16.37 (1.94)** | |
| SF-36 Mental Composite, LS mean change (SE) | Week 16 | 0.7 (0.87) | 3.19 (0.84)** | 4.03 (0.85)** | 1.83 (0.82) | |
| SF-36 Physical Composite Score, LS mean change (SE) | Week 16 | 2.67 (0.76) | 4.12 (0.74)** | 5.19 (0.74) | 3.58 (0.72) | |
| Nasal polyp surgery | ||||||
| Qualified for surgical evaluation, n/N (%) | Screening | 53/82 (64.6) | 45/81 (55.6) | 44/80 (55.0) | 47/78 (60.3) | |
| Week 16 | 27/68 (39.7) | 17/74 (23.0)a,** [OR = 0.322] |
21/69 (30.4) | 19/75 (25.3)** [OR = 0.387] |
||
| Week 24b (EDS-FLU 372 µg) | 15/64 (23.4) | 14/70 (20.0) | 17/63 (27.0) | 16/70 (22.9) | ||
Abbreviations: am, morning; BID, twice daily; CI, confidence interval; EDS-FLU, exhalation delivery system with fluticasone; LS, least squares; MOS-Sleep, Medical Outcomes Study Sleep Scale; n, total of number of patients randomized/enrolled/treated; n/N (%), number (%) of patients in the subset at the given time point; OR, odds ratio; PGIC, Patient Global Impression of Change; RSDI, Rhinosinusitis Disability Index; SE, standard error; SF-36, 36-Item Short-Form Health Survey; SNOT-22, Sinonasal Outcome Test-22.
aData are from the Full Analysis Set with Imputation.
bAll patients received EDS-FLU 372 µg during the extension phase.
*P < .001 versus EDS-placebo.
**P < .05.