Sinusitis
Conditions
Keywords
sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
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.
Interventions
Ectoin Rhinitis Nasal Spray
DRUGSinupret forte
Sponsors
Bitop AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Contra indications according to the label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score | day 1, day 7, day 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Contacts
STUDY_DIRECTORRalph Mösges, Prof.
Institut für Med. Informatik, Statistik und Epidemiologie
Outcome results
None listed