NCT01684540CompletedNot Applicable
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bitop AG
- Enrollment
- 66
- Locations
- 6
- Primary Endpoint
- Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
Time Frame: day 1, day 7, day 14
Secondary Outcomes
- 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)
Investigators
Study Sites (6)
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