Effect of Postoperative Additive Systemic Steroids in CRSwNP

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status and phase: Completed; Phase 4

Conditions: Sinusitis, Chronic

Treatments: Other: Placebo; Drug: Systemic Steroid (Prednisolone)

Study type: Interventional

Funder types: Other

Identifiers

NCT04915456

NP1

Details and patient eligibility

About

This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (CRSwNP). All patients receive a functional endoscopic sinus surgery (FESS) followed by topical steroid spray for 3 months. Postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. Patients will be followed for 2 years. Effect on Nasal Polyp score (NPS), Lund-Kennedy-Score (LKS), recurrence rates, smell scores, Rhinosinusitis Disability Index (RSDI), Short-Form 36 (SF-36) and mucus/serum biomarkers will be measured.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CRSwNP
• refractory to medical therapy
• no previous sinus surgery
• Lund-Kennedy-Score ≥ 1
• Lund-Mackay-Score ≥ 10

Exclusion criteria

• ciliary impairment
• autoimmune disease
• cystic fibrosis
• immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Systemic steroid (Prednisolone)

Experimental group

Description:

Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets

Treatment:

Drug: Systemic Steroid (Prednisolone)

Placebo

Placebo Comparator group

Description:

Lactose monohydrate, tablets

Treatment:

Other: Placebo