Table 2. Efficacy Results.
| Endpoints | Treatment (N = 80) |
Control (N = 80) |
Mean Difference (95% CI) | ||
|---|---|---|---|---|---|
| No.a | Value | No.a | Value | ||
| By Independent Reviewer at Day 30 | |||||
| Primary efficacy endpoint, No. (%) | |||||
| Need for postoperative interventionb | 61c | 7 (11.5) | 61c | 20 (32.8) | −21.3% (−35.1% to −7.6%) |
| Need for surgical intervention | 58c | 4 (6.9) | 58c | 15 (25.9) | −19.0% (−32.8% to −5.1%) |
| Need for oral steroid intervention | 61c | 6 (9.8) | 61c | 10 (16.4) | −6.6% (−17.1% to 4.0%) |
| By Clinical Investigators at Day 30 | |||||
| Secondary efficacy endpoints, No. (%) | |||||
| Need for postoperative interventionb | 75d | 12 (16.0) | 75d | 25 (33.3) | −17.3% (−27.9% to −6.7%) |
| Need for surgical intervention | 75d | 3 (4.0) | 75d | 11 (14.7) | −10.7% (−18.9% to −2.3%) |
| Need for oral steroid intervention | 75d | 11 (14.7) | 75d | 17 (22.7) | −8.0% (−17.4% to 1.4%) |
| Inflammation (100-mm VAS), mean (SD) | 79d | 23.1 (24.2) | 77d | 35.6 (31.1) | −12.3 (−18.3 to −6.4) |
| Occlusion/restenosis of FSO, No. (%) | 75d | 10 (13.3) | 75d | 27 (36.0) | −22.7% (−33.5% to −11.9%) |
| Estimated FSO diameter, mean (SD), mm | 79d | 6.3 (2.7) | 75d | 4.5 (3.2) | 1.9 (1.3 to 2.5) |
| By clinical investigators at day 90 | |||||
| Inflammation (100-mm VAS), mean (SD) | 76d | 26.0 (31.2) | 77d | 31.9 (32.1) | −5.5 (−11.3 to 0.3) |
| Occlusion/restenosis of FSO, No. (%) | 69d | 16 (23.2) | 69d | 28 (40.6) | −17.4% (−28.6% to −6.1%) |
| Estimated FSO diameter, mean (SD), mm | 68d | 5.7 (3.2) | 68d | 4.7 (3.4) | 1.0 (0.2 to 1.7) |
| Frontal L-M CT stage, mean (SD) | 78d | 0.7 (0.6) | 78d | 0.9 (0.7) | −0.2 (−0.3 to −0.1) |
Abbreviations: CT, computed tomography; FSO, frontal sinus ostia; L-M, Lund-Mackay; VAS, visual analog scale.
No. of patients with evaluable sinuses.
Postoperative intervention was a composite end point including surgical intervention required to debride obstructive adhesions/scarring formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale) and/or oral steroid intervention warranted to resolve recurrent inflammation or polypoid edema in the frontal recess/FSO.
The number of sinuses evaluable based on grading of video endoscopies by independent reviewer varied by parameter. Data were considered missing if the independent reviewer could not grade a video owing to suboptimal video quality or inadequate imaging of the relevant anatomy. Inadequate imaging of the relevant anatomy can occur when polyps in the ethmoid cavity or adhesions of the middle turbinate prevent visualization of the FSO.
The number of sinuses evaluable varied by parameter based on ability to visualize relevant anatomy. For example, presence of polyps in frontal recess or a middle turbinate adhesion can prevent visualization of the FSO, and therefore, estimation of ostial diameter or patency.