Phase 2 N=14 Randomized Treatment

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

Rhinosinusitis · Chronic Polyposis

Bottom Line

View on ClinicalTrials.gov: NCT01946711 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2022

Primary outcome: Primary: Change of Inflammation of the Nasal Mucosa and Paranasal Sinus — -2; -0.8 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Budesonide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pari Pharma GmbH
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change of Inflammation of the Nasal Mucosa and Paranasal Sinus	-2; -0.8	—
SECONDARY Safety Assessment	5; 4	—

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.

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01946711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.