Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
- Conditions
- Sinusitis
- Registration Number
- NCT01684540
- Lead Sponsor
- Bitop AG
- Brief Summary
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- Female or male individuals ≥ 18 years
- Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period
- Contra indications according to the label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score day 1, day 7, day 14
- Secondary Outcome Measures
Name Time Method Quality of Life questionnaire (Rhino QoL) day 1, day 7, day 14 Rhinoscopy day 1, day 7, day 14 Patient's and physician's judgment of efficacy day 7, day 14
Trial Locations
- Locations (6)
Dr. med. Norbert Pasch
🇩🇪Aachen, Germany
Peter Hinterkausen
🇩🇪Koeln, Germany
Dr. med. Wilhelm Schuetz
🇩🇪Juelich, Germany
Taufik Shahab
🇩🇪Koeln, Germany
Dr. med. Martin Sondermann
🇩🇪Aachen, Germany
Dr. med. Georg Krueckels
🇩🇪Aachen, Germany