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

February 14, 2022 updated by: Pari Pharma GmbH

A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • University Göttingen
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Munich, Germany, 81377
        • University LMU Munich
      • Rosenheim, Germany, 83022
        • HNO-Zentrum Mangfall-Inn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buparid; Treatment A
Buparid 1 mg budesonide/2 ml nebuliser solution
Drug: Budesonide
Inhalation
Drug: Budesonide
Nasal spray
Active Comparator: Budes; Treatment B
Budes® Nasal Spray 50 µg budesonide/pump
Drug: Budesonide
Inhalation
Drug: Budesonide
Nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
Time Frame: 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.
Change from Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment
Time Frame: 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.
up to 26 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-specific Quality of Life
Time Frame: 24 weeks

Health-specific quality of life was assessed by means of the self-rated, 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 total score has a (theoretical) range of 0 - 110 points, with higher scores indicating more severe impairment.

Presented are the mean values of the SNOT-22 total score after 24 weeks minus value at day 0 (baseline).
24 weeks
Nasal Obstruction
Time Frame: 4 weeks / 8 weeks
Nasal obstruction was assessed using the method of rhinomanometry by measuring the positive nasal inspiratory flow (PNIF). For the assessment the subject had to inhale maximally through the nose three times and the highest value of flow rate was recorded after 4 weeks and 8 weeks of treatment.
4 weeks / 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pari Pharma GmbH

Investigators

  • Principal Investigator: Sven Becker, MD, Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2013

Primary Completion (Actual)

February 3, 2020

Study Completion (Actual)

June 21, 2021

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12082.101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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