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

Phase 1

Completed

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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Buparid; Treatment A	Budesonide	Buparid 1mg budesonide/2 ml nebulizer solution
Budes; Treatment B	Budesonide	Budes Nasal Spray 50 µg budesonide/pump

Primary Outcome Measures

Name	Time	Method
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus	Change from Baseline to week 8	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.

Secondary Outcome Measures

Name	Time	Method
Nasal Obstruction	4 weeks / 8 weeks	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.
Health-specific Quality of Life	change of SNOT-20 total score from baseline to week 48	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).
Inflammation of the Nasal Mucosa and Paranasal Sinus	Changes from Baseline at Week 8	Determination of the thickness of the mucosa using Magnetic Resonance Imaging
Safety Assessment	48 weeks	Treatment-emergent adverse events

Locations (3): UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
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Mainz, Germany
University Göttingen
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Göttingen, Germany
University Munich
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Munich, Germany