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

Rhinosinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946711
• Other study ID #: 12082.101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 28, 2013
• Est. completion date: June 21, 2021

Study information

• Verified date: February 2022
• Source: Pari Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 21, 2021
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Polyposis
• Colorectal Neoplasms
• Nasopharyngeal Neoplasms
• Rhinosinusitis
• Sinusitis

Intervention

Drug:
• Budesonide
Inhalation
• Budesonide
Nasal spray

Locations

Country	Name	City	State
Germany	University Göttingen	Göttingen
Germany	UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz	Mainz
Germany	University LMU Munich	Munich
Germany	HNO-Zentrum Mangfall-Inn	Rosenheim

Sponsors (1)

Lead Sponsor	Collaborator
Pari Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-specific Quality of Life	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
Other	Nasal Obstruction	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
Primary	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	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.	up to 26 weeks