<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/NCT03282045</url>
  </required_header>
  <id_info>
    <org_study_id>BOS_CS_01</org_study_id>
    <nct_id>NCT03282045</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat</brief_title>
  <official_title>A Multicenter, Single-blind, Randomized, Placebo-controlled Comparative Study on Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® Spray and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat in Common Cold</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bosnalijek D.D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MonitorCRO</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bosnalijek D.D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this multicenter, single-blind, randomized, placebo-controlled,&#xD;
      prospective, comparative study with parallel design and 4-arms is to evaluate superiority of&#xD;
      Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray®&#xD;
      against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the&#xD;
      pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4&#xD;
      centers in Turkey.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      The primary objective of this study is to evaluate superiority of Lysobact Complete Spray®&#xD;
      against placebo and non inferiority of Lysobact Complete Spray® against active comparators&#xD;
      (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by&#xD;
      the patient using Sore Throat Pain Intensity Scale (STPIS).&#xD;
&#xD;
      Secondary objective(s):&#xD;
&#xD;
        -  Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal®&#xD;
           Oromucosal Spray, based on the frequency and nature of adverse events occurring during&#xD;
           treatment period.&#xD;
&#xD;
        -  Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in&#xD;
           Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.&#xD;
&#xD;
        -  Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day&#xD;
           2, Day 4 and Day 6, as compared with baseline.&#xD;
&#xD;
        -  Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as&#xD;
           compared with baseline.&#xD;
&#xD;
      Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active&#xD;
      comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      • Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.&#xD;
&#xD;
      Secondary endpoint(s):&#xD;
&#xD;
      Secondary endpoints are as follows:&#xD;
&#xD;
        -  change from baseline to Day 6 in mean VAS score for DSS&#xD;
&#xD;
        -  change from baseline to Day 6 in mean VAS score for SwoTS&#xD;
&#xD;
        -  change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS&#xD;
&#xD;
        -  percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS&#xD;
           and SwoTS&#xD;
&#xD;
        -  Incidence of adverse events and relationship to the study treatments&#xD;
&#xD;
        -  Incidence of serious adverse events and relationship to the study treatments&#xD;
&#xD;
      Statistical methods:&#xD;
&#xD;
      All patients who have received at least one dose of any study medication will be included in&#xD;
      the safety evaluation (safety population). Patients who have completed all visits according&#xD;
      to the protocol will be included in the efficacy population. The superiority and inferiority&#xD;
      of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the&#xD;
      mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2,&#xD;
      4 and 6.&#xD;
&#xD;
      Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is&#xD;
      defined as the end of the follow up period for the last patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">May 24, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators</measure>
    <time_frame>Day 6</time_frame>
    <description>The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">346</enrollment>
  <condition>Sore Throat</condition>
  <arm_group>
    <arm_group_label>Lysobact Complete Sprey</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lysobact Complete Sprey&#xD;
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open&#xD;
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tantum Verde® Spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tantum Verde® Spray&#xD;
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.&#xD;
Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pharyngal® Oromucosal Spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pharyngal® Oromucosal Spray&#xD;
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.&#xD;
Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open.&#xD;
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lysobact Complete Sprey</intervention_name>
    <description>Inhaling spray</description>
    <arm_group_label>Lysobact Complete Sprey</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tantum Verde® Spray</intervention_name>
    <description>Inhaling spray</description>
    <arm_group_label>Tantum Verde® Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharyngal® Oromucosal Spray</intervention_name>
    <description>Inhaling spray</description>
    <arm_group_label>Pharyngal® Oromucosal Spray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inhaling spray</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a&#xD;
             scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of&#xD;
             pharyngeal infection, with a score of ≥5&#xD;
&#xD;
          -  Patients who will be treated only on a symptomatic treatment basis, and with a&#xD;
             prescribed a oropharyngeal spray&#xD;
&#xD;
          -  Patients, 18 years of age and above, who provided an informed consent&#xD;
&#xD;
          -  Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours&#xD;
&#xD;
          -  Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale&#xD;
             (STPIS)&#xD;
&#xD;
          -  Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale&#xD;
             (DSS)&#xD;
&#xD;
          -  Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale&#xD;
             (SwoTS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had any previous (within 4 hours prior to screening examination) throat&#xD;
             lozenge treatment/use&#xD;
&#xD;
          -  Patients who had used any flu-preparation which contains any analgesic ingredient such&#xD;
             as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant&#xD;
&#xD;
          -  Patients who had analgesic use (any) 4 hours prior to the screening examination&#xD;
&#xD;
          -  Patients who are prescribed an antibiotic use before the screening visit and are&#xD;
             entitled to use antibiotics during the course of this non-interventional study&#xD;
&#xD;
          -  Patients with a known hypersensitivity to active/inactive ingredients of medications&#xD;
             which is prescribed for the symptomatic treatment of sore throat&#xD;
&#xD;
          -  Patients with known hypersensitiveness to egg white and other allergens&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#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>OZGUN ENVER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina</name>
      <address>
        <city>Banja Luka</city>
        <zip>78000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bosnia and Herzegovina</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute sore throat</keyword>
  <keyword>lysobact</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</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/NCT03282045
org study id: BOS_CS_01
nct id: NCT03282045
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of this multicenter, single-blind, randomized, placebo-controlled,
      prospective, comparative study with parallel design and 4-arms is to evaluate superiority of
      Lysobact Complete Spray® against placebo and non inferiority of Lysobact Complete Spray®
      against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the
      pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
This study will be conducted in approximately 3 centers in Bosnia Herzegovina and in 4
      centers in Turkey.

      Primary objective:

      The primary objective of this study is to evaluate superiority of Lysobact Complete Spray®
      against placebo and non inferiority of Lysobact Complete Spray® against active comparators
      (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by
      the patient using Sore Throat Pain Intensity Scale (STPIS).

      Secondary objective(s):

        -  Safety evaluation of Lysobact Complete Spray®, Tantum Verde® Spray, Pharyngal®
           Oromucosal Spray, based on the frequency and nature of adverse events occurring during
           treatment period.

        -  Extent of change in difficulty in swallowing, evaluated on the basis of Difficulty in
           Swallowing Scale (DSS), on Day 2, Day 4 and Day 6, as compared with baseline.

        -  Extent of change in swollen throat evaluation based on Swollen Throat Scale (STS) on Day
           2, Day 4 and Day 6, as compared with baseline.

        -  Change in frequency of study treatment applications on Day 2, Day 4 and Day 6, as
           compared with baseline.

      Test product: Lysobact Complete Spray® Active comparator product: Tantum Verde® Spray Active
      comparator product: Pharyngal® Oromucosal Spray Placebo product: Placebo

      Primary endpoint:

      • Primary endpoint is the change from baseline to Day 6 in mean VAS score for STPIS.

      Secondary endpoint(s):

      Secondary endpoints are as follows:

        -  change from baseline to Day 6 in mean VAS score for DSS

        -  change from baseline to Day 6 in mean VAS score for SwoTS

        -  change from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS and SwoTS

        -  percent improvement from baseline to each visit (Day 2, Day 4, Day 6) for STPIS , DSS
           and SwoTS

        -  Incidence of adverse events and relationship to the study treatments

        -  Incidence of serious adverse events and relationship to the study treatments

      Statistical methods:

      All patients who have received at least one dose of any study medication will be included in
      the safety evaluation (safety population). Patients who have completed all visits according
      to the protocol will be included in the efficacy population. The superiority and inferiority
      of Lysobact Complete Spray® will be tested in hierarchical order by the comparison of the
      mean change of VAS scores [Sore Throat Pain Intensity Scale (STPIS)] from baseline to Day 2,
      4 and 6.

      Planned treatment duration is 5 days. Safety will be followed-up until Day 6. End of study is
      defined as the end of the follow up period for the last patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators
time frame: Day 6
description: The primary objective of this study is to evaluate superiority of Lysobact Complete Spray® against placebo and non-inferiority of Lysobact Complete Spray® against active comparators (Tantum Verde® and Pharyngal®) in terms of efficacy based on the pain VAS scores evaluated by the patient using Sore Throat Pain Intensity Scale (STPIS).
arm group label: Lysobact Complete Sprey
arm group type: Experimental
description: Lysobact Complete Sprey
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.
arm group label: Tantum Verde® Spray
arm group type: Active Comparator
description: Tantum Verde® Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose.
arm group label: Pharyngal® Oromucosal Spray
arm group type: Active Comparator
description: Pharyngal® Oromucosal Spray
Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride.
arm group label: Placebo
arm group type: Placebo Comparator
description: Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open.
Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times.
intervention type: Drug
intervention name: Lysobact Complete Sprey
description: Inhaling spray
arm group label: Lysobact Complete Sprey
intervention type: Drug
intervention name: Tantum Verde® Spray
description: Inhaling spray
arm group label: Tantum Verde® Spray
intervention type: Drug
intervention name: Pharyngal® Oromucosal Spray
description: Inhaling spray
arm group label: Pharyngal® Oromucosal Spray
intervention type: Drug
intervention name: Placebo
description: Inhaling spray
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: OZGUN ENVER, MD
role: Principal Investigator
affiliation: Istanbul University - Cerrahpasa (IUC)
facility: 
country: Bosnia and Herzegovina
responsible party type: Sponsor
mesh term: Pharyngitis