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NCT01684540 Clinical Trial

Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Sinusitis Clinical Trial

— SNS01  

Official title:
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01684540
Other study ID # PPL-047
Secondary ID NIS SNS01
Status Completed
Phase N/A
First received September 11, 2012
Last updated September 21, 2012
Start date February 2012
Est. completion date August 2012

Study information
Verified date September 2012
Source Bitop AG
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Medical Device, Drug-like
Ectoin Rhinitis Nasal Spray
Drug:
• Sinupret forte

Locations
Country Name City State
Germany Dr. med. Georg Krueckels Aachen
Germany Dr. med. Martin Sondermann Aachen
Germany Dr. med. Norbert Pasch Aachen
Germany Dr. med. Wilhelm Schuetz Juelich
Germany Peter Hinterkausen Koeln
Germany Taufik Shahab Koeln

Sponsors (1)
Lead Sponsor Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score day 1, day 7, day 14 No
Secondary Quality of Life questionnaire (Rhino QoL) day 1, day 7, day 14 No
Secondary Rhinoscopy day 1, day 7, day 14 No
Secondary Patient's and physician's judgment of efficacy day 7, day 14 No
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