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

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pari Pharma GmbH
• Treatments: Budesonide

Criteria

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)