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Late-Breaking Scientific Oral Presentations

Rhinology/Allergy

Session: Late Breaking Scientific Orals 3

In-office, intra-sinus application of 0.0644% betamethasone dipropionate nasal cream (nasal-BMDP): Phase 2 OT-007b trial results

Monday, October 13, 2025

4:42 PM - 4:48 PM EDT

Location: 233-234

Disclosure(s):

Anders U. Cervin, MD, PhD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Introduction: Appropriate medical therapy for chronic rhinosinusitis (CRS) comprises intranasal corticosteroids, saline rinsing, and short courses of systemic corticosteroids (SCS). Endoscopic sinus surgery (ESS), and biologics (in selected cases), are indicated for failed medical therapy. Medically refractory symptoms, polyp recurrence, and acute flares are common. In-office treatment options are limited and avoiding SCS is challenging.

Methods: This was a multicentre, single-group, open-label, non-randomised study. Eligible patients were 18+ years, with persistent CRS symptoms despite undergoing ESS and appropriate medical therapy. Patients received one application of nasal-BMDP cream onto the sinus mucosa. Co-primary endpoints were change from baseline at week 3 in 4 Cardinal Symptom Score (4CSS) and Sino-Nasal Outcome Test (SNOT-22). Secondary efficacy assessments included endoscopic examination (modified Lund-Kennedy Score [MLKS]), 3CSS, global disease severity score (GDSS), and patient global impression score (PGIS).

Results: Twenty-three patients (39.1% male, age range 30-77, 54.5% eosinophilic) were treated. Nasal-BMDP cream significantly improved the co-primary endpoints. At week 3, 69.9% of patients experienced clinically meaningful improvements in SNOT-22. Improvements from baseline were observed for SNOT-22 (-17.70; 95%CI-24.42,-10.99), 4CSS (-3.99; 95%CI-5.30,-2.67), 3CSS (-3.00; 95%CI-3.94,-2.06), GDSS (-20.38; 95%CI-27.99,-12.78), and MLKS (-0.72; 95%CI-1.25,-0.19). Overall, 91.3% of patients reported an improvement in PGIS (with 60.1% reporting being much/very much improved). Adverse events (AEs) were mostly mild (73.9%). No serious AEs were reported.

Conclusions: Endoscopic in-office intra-sinus application of nasal-BMDP cream improved symptom control in post-ESS patients with refractory CRS. These promising results support further exploration of nasal-BMDP cream as a potential in-office treatment for refractory CRS symptoms.

Presenting Author(s)

Anders U. Cervin, MD, PhD

Honorary Professor of Otolaryngology (Rhinology)
University of Queensland
Helsingborg, Skane Lan, Sweden

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

EO

Eng H. Ooi, MBBS, PhD, FRACS

Flinders Medical Centre, Adelaide ENT Surgery Flinders Private Hospital and Flinders University
Adelaide, South Australia, Australia

Disclosure information not submitted.
AW

Abigail Walker, MBChB, FRCS (ORL-HNS)

Royal Brisbane and Women’s Hospital
Brisbane, Queensland, Australia

Disclosure information not submitted.
NS

Narinder Singh, MBBS, MS, FRACS

Westmead Hospital and University of Sydney
Sydney, New South Wales, Australia

Disclosure information not submitted.
CS

Chady Sader, MBBS, FRACS

Sir Charles Gairdner Hospital
Perth, Western Australia, Australia

Disclosure information not submitted.
PS

Patrick W. Slater, MD

Austin Ear Clinic
Austin, Texas, United States

Disclosure information not submitted.

Senior Author(s)

Anders U. Cervin, MD, PhD

Honorary Professor of Otolaryngology (Rhinology)
University of Queensland
Helsingborg, Skane Lan, Sweden

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.