Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
SNS01
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
2 other identifiers
observational
66
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2012
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2012
CompletedFirst Posted
Study publicly available on registry
September 13, 2012
CompletedJanuary 29, 2026
January 1, 2026
6 months
September 11, 2012
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
day 1, day 7, day 14
Secondary Outcomes (3)
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
Interventions
Ectoin Rhinitis Nasal Spray
Eligibility Criteria
Primary Care Clinic
You may qualify if:
- 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
You may not qualify if:
- Contra indications according to the label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bitop AGlead
Study Sites (6)
Dr. med. Georg Krueckels
Aachen, Germany
Dr. med. Martin Sondermann
Aachen, Germany
Dr. med. Norbert Pasch
Aachen, Germany
Peter Hinterkausen
Cologne, Germany
Taufik Shahab
Cologne, Germany
Dr. med. Wilhelm Schuetz
Jülich, Germany
Related Publications (1)
Eichel A, Wittig J, Shah-Hosseini K, Mosges R. A prospective, controlled study of SNS01 (ectoine nasal spray) compared to BNO-101 (phytotherapeutic dragees) in patients with acute rhinosinusitis. Curr Med Res Opin. 2013 Jul;29(7):739-46. doi: 10.1185/03007995.2013.800474. Epub 2013 May 14.
PMID: 23621514DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ralph Mösges, Prof.
Institut für Med. Informatik, Statistik und Epidemiologie
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2012
First Posted
September 13, 2012
Study Start
February 1, 2012
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
January 29, 2026
Record last verified: 2026-01