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

Primary Purpose

Rhinosinusitis, Chronic Polyposis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Budesonide
Budesonide
Sponsored by
Pari Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinosinusitis focused on measuring CRS, polyposis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University Göttingen
  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
  • University LMU Munich
  • HNO-Zentrum Mangfall-Inn

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Buparid; Treatment A

Budes; Treatment B

Arm Description

Buparid 1 mg budesonide/2 ml nebuliser solution

Budes® Nasal Spray 50 µg budesonide/pump

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety Assessment
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.

Full Information

First Posted
September 4, 2013
Last Updated
February 14, 2022
Sponsor
Pari Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01946711
Brief Title
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis With Polyposis Nasi
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2013 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pari Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinosinusitis, Chronic Polyposis
Keywords
CRS, polyposis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buparid; Treatment A
Arm Type
Experimental
Arm Description
Buparid 1 mg budesonide/2 ml nebuliser solution
Arm Title
Budes; Treatment B
Arm Type
Active Comparator
Arm Description
Budes® Nasal Spray 50 µg budesonide/pump
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Inhalation
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Nasal spray
Primary Outcome Measure Information:
Title
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
Description
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.
Time Frame
Change from Baseline to Week 8
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
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.
Time Frame
up to 26 weeks
Other Pre-specified Outcome Measures:
Title
Health-specific Quality of Life
Description
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).
Time Frame
24 weeks
Title
Nasal Obstruction
Description
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.
Time Frame
4 weeks / 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Becker, MD
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
University LMU Munich
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
HNO-Zentrum Mangfall-Inn
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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