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

NCT01955980 | Completed Phase 1 Results

• 1 other identifier: 12082.102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

The study should create data for the selection of a clinically relevant endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.

Conditions

Rhinosinusitis

Keywords

CRS; without 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 thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.

  Change from Baseline to week 8

Secondary Outcomes (4)

• Health-specific Quality of Life

  change of SNOT-20 total score from baseline to week 48

• Nasal Obstruction

  4 weeks / 8 weeks

• Inflammation of the Nasal Mucosa and Paranasal Sinus

  Changes from Baseline at Week 8

• Safety Assessment

  48 weeks

Study Arms (2)

Buparid; Treatment A

EXPERIMENTAL

Buparid 1mg budesonide/2 ml nebulizer 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
• Patient without alternative other than sinus surgery
• Patient's written informed consent obtained prior to any screening or study-specific procedure
• Male or female, ≥ 18 years of age
• Patient is able to undergo nasal therapy without restrictions
• Capable to correctly use the PARI SINUS device
• 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 is able to participate in the study according to Investigator's opinion

You may not qualify if:

• Patients with cystic fibrosis
• Patients with polyposis nasi grade I-IV
• Patients with prior FESS (Functional Endoscopic Sinus Surgery)
• Pregnant or breastfeeding women
• Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration
• No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
• Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
• Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
• Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the clinical trial
• Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
• Drug or alcohol abuse
• End-stage malignancies
• Known hypersensitivity to Budesonide
• Patients with oral steroid therapy within the last 3 months
• Patients needing \> 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma

Sponsors & Collaborators

• Pari Pharma GmbH: lead

Study Sites (3)

University Göttingen

Göttingen, 37099, Germany

Location

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

University Munich

Munich, 81377, 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

• Martin Canis, MD

  University Goettingen

  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 30, 2013
• First Posted: October 8, 2013
• Study Start: October 27, 2015
• Primary Completion: September 27, 2018
• Study Completion: July 29, 2021
• Last Updated: April 12, 2022
• Results First Posted: April 12, 2022

Record last verified: 2022-02

Locations

DE (3)