Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi

Phase 1

Completed

Brief Summary: The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.

Recruitment & Eligibility

Inclusion Criteria

Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
Patient with a PNIF of > 7 l/min separated for left and right side of the nose
Patient's written informed consent
Male or female,>= 18 years of age
Patient is able to undergo nasal therapy without restrictions
Capable of understanding the purpose and risk of the clinical trial
Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration
Patient has completed correctly the diary during the Wash-in Phase

Exclusion Criteria

Patients with cystic fibrosis
Patients with polyposis nasi grade IV
Patients with prior sinonasal surgery (exemption: polypectomy)
Patients with primary ciliaritis
Pregnant or breastfeeding women
Patients with suspected active upper airway infection
Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
Drug or alcohol abuse
End-stage malignancies
Known hypersensitivity to Budesonide
Patients with oral steroid therapy within the last 4 weeks
Patients with frequent epistaxis (> 2 per month)

Arm && Interventions

Group	Intervention	Description
Buparid; Treatment A	Budesonide	Buparid 1 mg budesonide/2 ml nebuliser solution
Budes; Treatment B	Budesonide	Budes® Nasal Spray 50 µg budesonide/pump

Primary Outcome Measures

Name	Time	Method
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus	Change from Baseline to Week 8	Inflammation of the nasal mucosa and paranasal sinus was assessed using the Lund-Mackay score based on magnetic resonance imaging. The score can take on values between 0 and 24 points, with higher values indicating more severe impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.

Secondary Outcome Measures

Name	Time	Method
Safety Assessment	up to 26 weeks	Treatment-emergent adverse events (AEs) Each participant has been monitored for adverse events up to 26 weeks. All patients withdrawn from the study will be followed-up for AEs or SAEs for further 2 weeks or 4 weeks, respectively.

Locations (4): HNO-Zentrum Mangfall-Inn
🇩🇪
Rosenheim, Germany
University LMU Munich
🇩🇪
Munich, Germany
University Göttingen
🇩🇪
Göttingen, Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
🇩🇪
Mainz, Germany