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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684540
First Posted: September 13, 2012
Last Update Posted: September 24, 2012
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.
Information provided by (Responsible Party):
Bitop AG
  Purpose
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 Intervention
Sinusitis Other: Medical Device, Drug-like Drug: Sinupret forte

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Bitop AG:

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

Enrollment: 66
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Medical Device, Drug-like
    Ectoin Rhinitis Nasal Spray
    Drug: Sinupret forte
  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01684540


Locations
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, Germany
Sponsors and Collaborators
Bitop AG
Investigators
Study Director: Ralph Mösges, Prof. Institut für Med. Informatik, Statistik und Epidemiologie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT01684540     History of Changes
Other Study ID Numbers: PPL-047
NIS SNS01
First Submitted: September 11, 2012
First Posted: September 13, 2012
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:
Rhinitis
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases