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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bitop AG
ClinicalTrials.gov Identifier:
NCT01684540
First received: September 11, 2012
Last updated: September 21, 2012
Last verified: September 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life questionnaire (Rhino QoL) [ Time Frame: day 1, day 7, day 14 ] [ Designated as safety issue: No ]
  • Rhinoscopy [ Time Frame: day 1, day 7, day 14 ] [ Designated as safety issue: No ]
  • Patient's and physician's judgment of efficacy [ Time Frame: day 7, day 14 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684540

Locations
Germany
Dr. med. Norbert Pasch
Aachen, Germany
Dr. med. Georg Krueckels
Aachen, Germany
Dr. med. Martin Sondermann
Aachen, Germany
Dr. med. Wilhelm Schuetz
Juelich, Germany
Taufik Shahab
Koeln, Germany
Peter Hinterkausen
Koeln, Germany
Sponsors and Collaborators
Bitop AG
Investigators
Study Director: Ralph Mösges, Prof. Institut für Med. Informatik, Statistik und Epidemiologie
  More Information

No publications provided by Bitop AG

Additional 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
Study First Received: September 11, 2012
Last Updated: September 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on August 28, 2014