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

September 21, 2012 updated by: Bitop AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany
        • Dr. med. Georg Krueckels
      • Aachen, Germany
        • Dr. med. Martin Sondermann
      • Aachen, Germany
        • Dr. med. Norbert Pasch
      • Juelich, Germany
        • Dr. med. Wilhelm Schuetz
      • Koeln, Germany
        • Peter Hinterkausen
      • Koeln, Germany
        • Taufik Shahab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
Time Frame: day 1, day 7, day 14
day 1, day 7, day 14

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bitop AG

Investigators

  • Study Director: Ralph Mösges, Prof., Institut für Med. Informatik, Statistik und Epidemiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 13, 2012

Study Record Updates

Last Update Posted (Estimate)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 21, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPL-047
  • NIS SNS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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