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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Inhalation
Nasal Spray
University Göttingen
Göttingen, Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Germany
University Munich
Munich, Germany
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.
Time frame: Change from Baseline to week 8
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).
Time frame: 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.
Time frame: 4 weeks / 8 weeks
Inflammation of the Nasal Mucosa and Paranasal Sinus
Determination of the thickness of the mucosa using Magnetic Resonance Imaging
Time frame: Changes from Baseline at Week 8
Safety Assessment
Treatment-emergent adverse events
Time frame: 48 weeks
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