At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 14 enrolled
Drug / intervention
Budesonide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Budesonide for Rhinosinusitis and Chronic Polyposis. Completed, enrolled 14 participants across 4 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRhinosinusitis, Chronic Polyposis
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionFeb 2020
Study CompletionJun 2021
TodayJul 2026
First PostedSep 20, 2013
Enrollment StartAug 28, 2013
Primary CompletionFeb 3, 2020
Study CompletionJun 21, 2021
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 12.8 years ago
Interventions
Budesonidedrug
Inhalation
Budesonidedrug
Nasal spray