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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinosinusitis, Chronic Polyposis

Intervention / Treatment
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* Drug: Budesonide
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRS, polyposis