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

Study Overview
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Brief Summary
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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.

Detailed Description
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The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct a pivotal study.

Official Title
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A Pilot Study to Investigate the Potential of Buparid/PARI SINUS Versus Budes® Nasal Spray to Avoid or Postpone Sinus Surgery in Adult Patients With Chronic Rhinosinusitis

Conditions
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Rhinosinusitis

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 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 Exclusion Criteria: 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 Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics Patients with frequent epistaxis (> 1 episode per week)

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 1mg budesonide/2 ml nebulizer 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-specific Quality of Life | Health-specific quality of life was assessed by means of the self-rated, 20-item Sino-Nasal Outcome Test (SNOT-20). The SNOT-20 total score has a (theoretical) range of 0 - 100 points, with higher scores indicating more severe impairment. Presented are the mean values of the SNOT-20 total score after 48 weeks minus value at day 0 (baseline). | change of SNOT-20 total score from baseline to week 48 | 
| 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 | 
| Inflammation of the Nasal Mucosa and Paranasal Sinus | Determination of the thickness of the mucosa using Magnetic Resonance Imaging | Changes from Baseline at Week 8 | 
| Safety Assessment | Treatment-emergent adverse events | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRS, without polyposis