drugset / Trial / NCT01946711

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

NCT01946711

Phase 1/2 Completed 14 enrolled Pari Pharma GmbH
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-08-28
Primary completion
2020-02-03
Completion
2021-06-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Budesonide Small molecule 50 ug Inhaled
Comparator Budesonide Small molecule 1 mg Inhaled