<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/NCT02196389</url>
  </required_header>
  <id_info>
    <org_study_id>Dec2013</org_study_id>
    <nct_id>NCT02196389</nct_id>
  </id_info>
  <brief_title>Comparison Between 4 Different Nasal Dilators</brief_title>
  <official_title>Comparison Between 4 Different Nasal Dilators: Objective vs Subjective Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several nasal dilators are currently commercially available, and can be applied endonasally&#xD;
      (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison&#xD;
      between these dilators has not been made so far, and would help the clinicians to advise the&#xD;
      use of any of these dilators. From clinical experience, endonasal dilators are well supported&#xD;
      and improve breathing better than the external dilators&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several nasal dilators are currently commercially available, and can be applied endonasally&#xD;
      (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison&#xD;
      between these dilators has not been made so far,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">March 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Nasal Inflammatory Flow</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in Peak Nasal Inflammatory Flow between the 4 different dilators</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>preference</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>surgery</measure>
    <time_frame>4 weeks</time_frame>
    <description>Patients' preference to continue to use the preferred dilator after the 4 weeks' trial period or choice to undergo surgery after one month of usage of the preferred dilator.</description>
  </other_outcome>
  <other_outcome>
    <measure>reasons of choice</measure>
    <time_frame>4 weeks</time_frame>
    <description>Specific reasons for the choice of the two dilators at baseline (functional vs aesthetic) at baseline</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Incompetence of Nasal Valve</condition>
  <arm_group>
    <arm_group_label>Nozovent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal Dilator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasanita</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal Dilator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breath Right</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal Dilator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Airmax</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal Dilator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal dilator Nasanita</intervention_name>
    <description>Nasal Dilator</description>
    <arm_group_label>Nasanita</arm_group_label>
    <other_name>Nasanita</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal dilator Nozovent</intervention_name>
    <arm_group_label>Nozovent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal dilator Breath Right</intervention_name>
    <arm_group_label>Breath Right</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal dilator Airmax</intervention_name>
    <arm_group_label>Airmax</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with nasal obstruction due to external nasal valve problems and with positive&#xD;
        Cottle sign.&#xD;
&#xD;
        Age &gt; 18 and &lt; 60 years. Ability to give reliable information and written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients with nasal obstruction due to other endonasal anatomic deformities besides&#xD;
        external nasal valve dysfunction.&#xD;
&#xD;
        Patients with rhinosinusitis and/or nasal polyps evaluated by nasal endoscopy. Patients&#xD;
        with chronic lower airway disease like severe asthma, chronic obstructive pulmonary disease&#xD;
        (COPD), bronchiectasis and/or other conditions that interfere with the generation of a&#xD;
        reliable Peak Nasal Inspiratory Flow (PNIF) result.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Hellings, Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Hellings, Prof Dr</last_name>
    <phone>+321632338</phone>
    <email>peter.hellings@uzleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Dekimpe, Msc</last_name>
      <phone>+3216340757</phone>
      <email>emily.dekimpe@uzleuven.be</email>
    </contact>
    <investigator>
      <last_name>Peter Hellings, Prof Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02196389
org study id: Dec2013
nct id: NCT02196389
lead sponsor: 
has dmc: No
Several nasal dilators are currently commercially available, and can be applied endonasally
      (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison
      between these dilators has not been made so far, and would help the clinicians to advise the
      use of any of these dilators. From clinical experience, endonasal dilators are well supported
      and improve breathing better than the external dilators
Several nasal dilators are currently commercially available, and can be applied endonasally
      (Airmax°, Nozovent and Nasanita°) or externally (Breath Right°). An objective comparison
      between these dilators has not been made so far,
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Nasal Inflammatory Flow
time frame: 4 weeks
description: Change in Peak Nasal Inflammatory Flow between the 4 different dilators
measure: preference
time frame: 4 weeks
description: Patients' preference of 2 out of 4 dilators tested at baseline for a trial period of 4 week duration.
measure: surgery
time frame: 4 weeks
description: Patients' preference to continue to use the preferred dilator after the 4 weeks' trial period or choice to undergo surgery after one month of usage of the preferred dilator.
measure: reasons of choice
time frame: 4 weeks
description: Specific reasons for the choice of the two dilators at baseline (functional vs aesthetic) at baseline
arm group label: Nozovent
arm group type: Active Comparator
description: Nasal Dilator
arm group label: Nasanita
arm group type: Active Comparator
description: Nasal Dilator
arm group label: Breath Right
arm group type: Active Comparator
description: Nasal Dilator
arm group label: Airmax
arm group type: Active Comparator
description: Nasal Dilator
intervention type: Device
intervention name: Nasal dilator Nasanita
description: Nasal Dilator
arm group label: Nasanita
other name: Nasanita
intervention type: Device
intervention name: Nasal dilator Nozovent
arm group label: Nozovent
intervention type: Device
intervention name: Nasal dilator Breath Right
arm group label: Breath Right
intervention type: Device
intervention name: Nasal dilator Airmax
arm group label: Airmax
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Peter Hellings, Prof Dr
role: Principal Investigator
affiliation: UZ Leuven
last name: Peter Hellings, Prof Dr
phone: +321632338
email: peter.hellings@uzleuven.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor