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

NCT01946711 | Completed Phase 1 Results

• 1 other identifier: 12082.101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 4

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.

Conditions

Rhinosinusitis; Chronic Polyposis

Keywords

CRS; polyposis

Outcome Measures

Primary Outcomes (1)

• Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

  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.

  Change from Baseline to Week 8

Secondary Outcomes (1)

• Safety Assessment

  up to 26 weeks

Other Outcomes (2)

• Health-specific Quality of Life

  24 weeks

• Nasal Obstruction

  4 weeks / 8 weeks

Study Arms (2)

Buparid; Treatment A

EXPERIMENTAL

Buparid 1 mg budesonide/2 ml nebuliser solution

Drug: Budesonide

Budes; Treatment B

ACTIVE COMPARATOR

Budes® Nasal Spray 50 µg budesonide/pump

Drug: Budesonide

Interventions

Budesonide DRUG

Inhalation

Buparid; Treatment A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pari Pharma GmbH: lead

Study Sites (4)

University Göttingen

Göttingen, 37075, Germany

Location

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

University LMU Munich

Munich, 81377, Germany

Location

HNO-Zentrum Mangfall-Inn

Rosenheim, 83022, Germany

Location

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Friedrich gruber
• Organization: Pari Pharma

friedrich.gruber@pari.com

+4989742846

Study Officials

• Sven Becker, MD

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 20, 2013
• Study Start: August 28, 2013
• Primary Completion: February 3, 2020
• Study Completion: June 21, 2021
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-02

Locations

DE (4)