<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01684540</url>
  </required_header>
  <id_info>
    <org_study_id>PPL-047</org_study_id>
    <secondary_id>NIS SNS01</secondary_id>
    <nct_id>NCT01684540</nct_id>
  </id_info>
  <brief_title>Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis</brief_title>
  <acronym>SNS01</acronym>
  <official_title>Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bitop AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bitop AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a comparative, open label, parallel group, non interventional study to further&#xD;
      demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition&#xD;
      the effectiveness and safety shall be compared to a Sinupret forte. The patient applies&#xD;
      Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use.&#xD;
      The observation takes place over a period of 14 days. Response to treatment is recorded at&#xD;
      day 7 and day 14 by the physician and in daily by the patient in a dairy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score</measure>
    <time_frame>day 1, day 7, day 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life questionnaire (Rhino QoL)</measure>
    <time_frame>day 1, day 7, day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rhinoscopy</measure>
    <time_frame>day 1, day 7, day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's and physician's judgment of efficacy</measure>
    <time_frame>day 7, day 14</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">66</enrollment>
  <condition>Sinusitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medical Device, Drug-like</intervention_name>
    <description>Ectoin Rhinitis Nasal Spray</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sinupret forte</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary Care Clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male individuals ≥ 18 years&#xD;
&#xD;
          -  Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray&#xD;
             or Sinupret forte during the observational period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra indications according to the label&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ralph Mösges, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Institut für Med. Informatik, Statistik und Epidemiologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. med. Georg Krueckels</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. med. Martin Sondermann</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. med. Norbert Pasch</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. med. Wilhelm Schuetz</name>
      <address>
        <city>Juelich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter Hinterkausen</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taufik Shahab</name>
      <address>
        <city>Koeln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 21, 2012</last_update_submitted>
  <last_update_submitted_qc>September 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01684540
org study id: PPL-047
secondary id: NIS SNS01
nct id: NCT01684540
lead sponsor: 
has dmc: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score
time frame: day 1, day 7, day 14
measure: Quality of Life questionnaire (Rhino QoL)
time frame: day 1, day 7, day 14
measure: Rhinoscopy
time frame: day 1, day 7, day 14
measure: Patient's and physician's judgment of efficacy
time frame: day 7, day 14
intervention type: Other
intervention name: Medical Device, Drug-like
description: Ectoin Rhinitis Nasal Spray
intervention type: Drug
intervention name: Sinupret forte
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ralph Mösges, Prof.
role: Study Director
affiliation: Institut für Med. Informatik, Statistik und Epidemiologie
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Sinusitis