Table 1.

Description of 2 RCTs Conducted to Assess the Safety and Efficacy of In-office Placement of an MF Sinus Implant.

Study	Trial Design Randomized/Completed Study	Treatment and Control	Follow-up Duration	Diagnosis and Eligibility Criteria	Coprimary Efficacy End Points	Secondary Efficacy End Points
RESOLVE14,15	Phase 2/3Randomized 1:1, parallel group, double-blind (patients, assessors), concurrently controlled, multicenter (18 sites in United States) n = 100/98T: n = 53/52C: n = 47/46	T: in-office bilateral placement of the MF sinus implant in the ethmoid sinuses plus daily MFNSC: in-office bilateral sham procedure plus daily MFNS	6 monthsImplant removal by day 60 to ensure blinding	CRS with NP Prior ESS with bilateral total ethmoidectomy Indicated for repeat ESS: NO/C symptoms despite ongoing use of INCS Bilateral NP (grade ≥ 2 on at least 1 side) by clinical investigators Ongoing use of INCS Recent systemic steroids Grade 4 polyps excluded	Change from baseline to day 90 in NO/C score (scale 0–5) as determined by patients using a reflective questionnaire Change from baseline to day 90 in BPG (scale 0–8), as determined by an independent panel of 3 sinus surgeons based on a centralized blinded video-endoscopy review	Prespecified, not-adjusted for multiplicity: Proportion of patients indicated for repeat ESS at day 90 and month 6 by clinical investigators Change from baseline to day 90 by panel and each time point by clinical investigators in ESO (VAS 0–100) Change from baseline to each time point in NO/C score (scale 0–5) as determined by patients using a reflective questionnaire Change from baseline to month 6 in NOSE score
RESOLVE II 16	Phase 3 pivotalRandomized 2:1, parallel group, double-blind (patients, assessors), concurrently controlled, multicenter (34 sites in United States) n = 300/298T: n = 201/200C: n = 99/98	T: in-office bilateral placement of the MF sinus implant in the ethmoid sinuses plus daily MFNSC: in-office bilateral sham procedure plus daily MFNS	90 daysImplant removal by day 60 to ensure blinding	CRS with NP Prior ESS with bilateral total ethmoidectomy Indicated for repeat ESS NO/C symptoms despite ongoing use of INCS (score ≥ 2 on 5 of 7 days by electronic diary) Bilateral NP (grade ≥2 on each side) by an independent reviewer Ongoing use of INCS Recent systemic steroids Grade 4 polyps excluded	Change from baseline to day 30 in NO/C score (scale 0–3) as determined by patients using a daily diary Change from baseline to day 90 in BPG (scale 0–8), as determined by an independent panel of 3 sinus surgeons based on a centralized blinded video-endoscopy review	Prespecified and adjusted for multiplicity: Proportion of patients indicated for RESS at day 90 by clinical investigators Change from baseline to day 90 in ESO (VAS 0–100) by an independent panel Change from baseline to day 90 in NO/C score (scale 0–3) Change from baseline to day 90 in decreased sense of smell score (scale 0–5) Change from baseline to day 90 in facial pain/pressure score (scale 0–5) using a reflective questionnaire (note: this end point was the only one that did not meet study objective)

Abbreviations: BPG, bilateral polyp grade; C, control group; CRS, chronic rhinosinusitis; ESO, ethmoid sinus obstruction; ESS, endoscopic sinus surgery; INCS, intranasal corticosteroid spray; MF, mometasone furoate; MFNS, MF nasal spray; NO/C, nasal obstruction/congestion; NOSE, Nasal Obstruction Symptom Evaluation; NP, nasal polyps; RCT, randomized control trial; RESS, revision ESS; T, treatment group; VAS, visual analog scale.

For all scales, higher scores indicate worse outcomes.