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

Pari Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rhinosinusitis; Chronic Polyposis

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01946711

12082.101

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Buparid; Treatment A

Experimental group

Description:

Buparid 1 mg budesonide/2 ml nebuliser solution

Treatment:

Drug: Budesonide

Drug: Budesonide

Budes; Treatment B

Active Comparator group

Description:

Budes® Nasal Spray 50 µg budesonide/pump

Treatment:

Drug: Budesonide

Drug: Budesonide