<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/NCT03251066</url>
  </required_header>
  <id_info>
    <org_study_id>PNSY2</org_study_id>
    <nct_id>NCT03251066</nct_id>
  </id_info>
  <brief_title>Immediate Effect of Proponent-Nasal-Spray on Unspecific Discomfort in the Nose</brief_title>
  <official_title>Open, Not Randomised, Non-blinded Observation Study to Investigate the Immediate Effect of Proponent - Nasal - Spray in Case of Unspecific Discomfort in the Nose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PRECLIN Biosystems AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>PRECLIN Biosystems AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal -&#xD;
      Spray after a one time administration (following a single dose administration in each&#xD;
      nostril) in an open, not randomised, non-blinded single centre observation study on 40&#xD;
      volunteers between 18-75 years of age with an unspecific discomfort in the nose such as&#xD;
      enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or&#xD;
      feeling of a dry nose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      By regularisation of environment of nasal mucosa and the following restitution and&#xD;
      improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably&#xD;
      enhanced, pathogens from the environment can be physically removed and a bacterial or viral&#xD;
      infection may be prevented on this way.&#xD;
&#xD;
      Such an optimizing effect may be reached by the administration of an equilibrated saline&#xD;
      solution with an optimal composition regarding osmolality, pH-value and buffer substance.&#xD;
&#xD;
      In addition it would be very advantageous to support the efficacy of the local unspecific and&#xD;
      specific immune mechanisms in the nasal respiratory mucosa (NALT) without any negative&#xD;
      effects on the optimized mucociliary clearance.&#xD;
&#xD;
      As demonstrated recently in airway mucosa sodium propionate is able to interact with&#xD;
      macrophages, the interleukin system and other factors of the TNF receptor family.&#xD;
&#xD;
      Sodium propionate could therefore have an ancillary effect on the genuine immune mechanisms&#xD;
      of nasal respiratory mucosa. On this way the primary effect of administration of saline&#xD;
      solution is supported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2017</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Every participant of the study will specify at the beginning of the investigation his subjective starting situation concerning the nasal discomfort.The participant records his/ her personal impression on the change of severity of the general symptoms or selected individual symptoms of unspecific nasal discomfort following the single administration of &quot;Proponent Nasal Spray&quot;. Every Patient serves as his own control.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is the safety endpoint (adverse events non-response rate).</measure>
    <time_frame>up to 48 hrs</time_frame>
    <description>This endpont is defined by the adverse events non-response rate based on the individual adverse events reported by the participant up to 60 min after treatment. The adverse events are specified and defined by scores. The sum score over time for all individual adverse event symptoms will be determined for each participant. Not more than 10 % of all participants of the study should report adverse events with a sum score &gt; 3 for one or more of the listed adverse events. Not more than 10 % of all participants of the study should report adverse events with a sum score &gt; 3 for one or more of the listed adverse effects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary endpoints of the study are the immediate response rate based on the &quot;Change of severity of general and selected individual symptoms of unspecific nasal discomfort&quot;.</measure>
    <time_frame>up to 48 hrs</time_frame>
    <description>The first co-secondary endpoint of the study is the immediate response rate based on the &quot;Change of severity of general symptoms of unspecific nasal discomfort&quot; following the single administration of &quot;Proponent Nasal Spray&quot; up to 60 min after treatment. The second co-secondary endpoint is the immediate response rate based on the &quot;Change of severity of selected individual symptoms&quot; of nasal discomfort following the single administration of &quot;Proponent Nasal Spray&quot; up to 60 min after treatment - provided the respective symptom was identified by a participant prior to the administration of &quot;Proponent Nasal Spray&quot; as a nasal discomfort.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Unspecified Disorder of Nose and Nasal Sinuses</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Proponent Nasal Spray Medical device</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proponent Nasal Spray</intervention_name>
    <description>The medical device consists of a Saline solution containing sodium propionate which is administered as single dose</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Key inclusion criteria are one or more of the following symptoms:&#xD;
&#xD;
          -  nasal discharge/ secretion (runny nose)&#xD;
&#xD;
          -  congested nose&#xD;
&#xD;
          -  sneezing&#xD;
&#xD;
          -  itchy nose&#xD;
&#xD;
          -  feeling of a dry nose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Key exclusion criteria:&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  75 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soyka Michael, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ORL, USZ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik für Ohren-, Nasen-, Hals- und Gesichtschirurgie University Zürich</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.</citation>
    <PMID>24390308</PMID>
  </results_reference>
  <results_reference>
    <citation>Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.</citation>
    <PMID>21865681</PMID>
  </results_reference>
  <results_reference>
    <citation>Achilles N, Mosges R. Nasal saline irrigations for the symptoms of acute and chronic rhinosinusitis. Curr Allergy Asthma Rep. 2013 Apr;13(2):229-35. doi: 10.1007/s11882-013-0339-y.</citation>
    <PMID>23354530</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nose Saline Solution Irrigation Nasal Spray</keyword>
  <keyword>Sodium propionate Locke-Ringer Solution</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nose Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03251066
org study id: PNSY2
nct id: NCT03251066
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of the immediate effect on subjective relief of symptoms by Proponent - Nasal -
      Spray after a one time administration (following a single dose administration in each
      nostril) in an open, not randomised, non-blinded single centre observation study on 40
      volunteers between 18-75 years of age with an unspecific discomfort in the nose such as
      enhanced nasal discharge/ secretion (runny nose), congested nose, sneezing, itchy nose or
      feeling of a dry nose.
By regularisation of environment of nasal mucosa and the following restitution and
      improvement of the ciliary function the efficacy of mucociliary clearance can be remarkably
      enhanced, pathogens from the environment can be physically removed and a bacterial or viral
      infection may be prevented on this way.

      Such an optimizing effect may be reached by the administration of an equilibrated saline
      solution with an optimal composition regarding osmolality, pH-value and buffer substance.

      In addition it would be very advantageous to support the efficacy of the local unspecific and
      specific immune mechanisms in the nasal respiratory mucosa (NALT) without any negative
      effects on the optimized mucociliary clearance.

      As demonstrated recently in airway mucosa sodium propionate is able to interact with
      macrophages, the interleukin system and other factors of the TNF receptor family.

      Sodium propionate could therefore have an ancillary effect on the genuine immune mechanisms
      of nasal respiratory mucosa. On this way the primary effect of administration of saline
      solution is supported.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Every participant of the study will specify at the beginning of the investigation his subjective starting situation concerning the nasal discomfort.The participant records his/ her personal impression on the change of severity of the general symptoms or selected individual symptoms of unspecific nasal discomfort following the single administration of "Proponent Nasal Spray". Every Patient serves as his own control.
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is the safety endpoint (adverse events non-response rate).
time frame: up to 48 hrs
description: This endpont is defined by the adverse events non-response rate based on the individual adverse events reported by the participant up to 60 min after treatment. The adverse events are specified and defined by scores. The sum score over time for all individual adverse event symptoms will be determined for each participant. Not more than 10 % of all participants of the study should report adverse events with a sum score > 3 for one or more of the listed adverse events. Not more than 10 % of all participants of the study should report adverse events with a sum score > 3 for one or more of the listed adverse effects.
measure: The secondary endpoints of the study are the immediate response rate based on the "Change of severity of general and selected individual symptoms of unspecific nasal discomfort".
time frame: up to 48 hrs
description: The first co-secondary endpoint of the study is the immediate response rate based on the "Change of severity of general symptoms of unspecific nasal discomfort" following the single administration of "Proponent Nasal Spray" up to 60 min after treatment. The second co-secondary endpoint is the immediate response rate based on the "Change of severity of selected individual symptoms" of nasal discomfort following the single administration of "Proponent Nasal Spray" up to 60 min after treatment - provided the respective symptom was identified by a participant prior to the administration of "Proponent Nasal Spray" as a nasal discomfort.
arm group label: Test group
arm group type: Other
description: Proponent Nasal Spray Medical device
intervention type: Other
intervention name: Proponent Nasal Spray
description: The medical device consists of a Saline solution containing sodium propionate which is administered as single dose
arm group label: Test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Soyka Michael, MD
role: Principal Investigator
affiliation: ORL, USZ
facility: 
country: Switzerland
citation: Trompette A, Gollwitzer ES, Yadava K, Sichelstiel AK, Sprenger N, Ngom-Bru C, Blanchard C, Junt T, Nicod LP, Harris NL, Marsland BJ. Gut microbiota metabolism of dietary fiber influences allergic airway disease and hematopoiesis. Nat Med. 2014 Feb;20(2):159-66. doi: 10.1038/nm.3444. Epub 2014 Jan 5.
PMID: 24390308
citation: Brandtzaeg P. Immune functions of nasopharyngeal lymphoid tissue. Adv Otorhinolaryngol. 2011;72:20-4. doi: 10.1159/000324588. Epub 2011 Aug 18.
PMID: 21865681
citation: Achilles N, Mosges R. Nasal saline irrigations for the symptoms of acute and chronic rhinosinusitis. Curr Allergy Asthma Rep. 2013 Apr;13(2):229-35. doi: 10.1007/s11882-013-0339-y.
PMID: 23354530
responsible party type: Sponsor
mesh term: Nose Diseases
sharing ipd: No