COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis (SNS01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684540
Recruitment Status : Completed
First Posted : September 13, 2012
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sinusitis Other: Medical Device, Drug-like Drug: Sinupret forte

Layout table for study information
Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis
Study Start Date : February 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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

Primary Outcome Measures :
  1. Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score [ Time Frame: day 1, day 7, day 14 ]

Secondary Outcome Measures :
  1. Quality of Life questionnaire (Rhino QoL) [ Time Frame: day 1, day 7, day 14 ]
  2. Rhinoscopy [ Time Frame: day 1, day 7, day 14 ]
  3. Patient's and physician's judgment of efficacy [ Time Frame: day 7, day 14 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684540

Layout table for location information
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, Germany
Sponsors and Collaborators
Bitop AG
Layout table for investigator information
Study Director: Ralph Mösges, Prof. Institut für Med. Informatik, Statistik und Epidemiologie

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bitop AG Identifier: NCT01684540    
Other Study ID Numbers: PPL-047
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012
Keywords provided by Bitop AG:
sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
Additional relevant MeSH terms:
Layout table for MeSH terms
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases