Trials / Completed
CompletedNCT01955980
Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Pari Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide | Inhalation |
| DRUG | Budesonide | Nasal Spray |
Timeline
- Start date
- 2015-10-27
- Primary completion
- 2018-09-27
- Completion
- 2021-07-29
- First posted
- 2013-10-08
- Last updated
- 2022-04-12
- Results posted
- 2022-04-12
Locations
3 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01955980. Inclusion in this directory is not an endorsement.