<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/NCT01699165</url>
  </required_header>
  <id_info>
    <org_study_id>1202-2</org_study_id>
    <secondary_id>CIV-12-06-007121</secondary_id>
    <secondary_id>1-10-72-371-12.</secondary_id>
    <nct_id>NCT01699165</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)</brief_title>
  <official_title>Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spirare ApS</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of reducing exposure to allergens in&#xD;
      patients with hay fever by means of a nasal filter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score</measure>
    <time_frame>Day 1 and day 15</time_frame>
    <description>To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry</measure>
    <time_frame>Day 1 and day 15</time_frame>
    <description>To assess the effects of active nasal filters on intranasal volume in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To assess symptoms using a VAS Scale symptoms questionnaire (PC)</measure>
    <time_frame>Day 1 and Day 15</time_frame>
    <description>On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post</description>
  </other_outcome>
  <other_outcome>
    <measure>To assess the tolerability and safety of nasal filters</measure>
    <time_frame>Day 1 and Day 15</time_frame>
    <description>By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure</description>
  </other_outcome>
  <other_outcome>
    <measure>To assess the effects on the lower airway via nitrogen oxide measurements during expiration.</measure>
    <time_frame>Day 1 and Day 15</time_frame>
    <description>On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure</description>
  </other_outcome>
  <other_outcome>
    <measure>Spirometric lung function</measure>
    <time_frame>Day 1 and Day 15</time_frame>
    <description>On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours</description>
  </other_outcome>
  <other_outcome>
    <measure>Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Ocular Symptom Score (TOSS)</measure>
    <time_frame>Day 1 and day 15</time_frame>
    <description>To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Ocular Symptom Score (TOSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Rhinitis, Allergic, Seasonal</condition>
  <arm_group>
    <arm_group_label>Placebo Nasal filter</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Placebo treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal Filter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal filter</intervention_name>
    <description>Active nasal filter</description>
    <arm_group_label>Nasal Filter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo nasal filter</intervention_name>
    <description>Placebo nasal filter</description>
    <arm_group_label>Placebo Nasal filter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study&#xD;
             entry. Documented by a positive skin test within 12 months of study enrollment.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Reliable anticonception for fertile women&#xD;
&#xD;
          -  Must be able to complete the study&#xD;
&#xD;
          -  Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value&#xD;
&#xD;
          -  Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive pregnancy test for fertile women&#xD;
&#xD;
          -  Asthma unless mild and only occurring in relation to the grass pollen season as&#xD;
             assessed by the investigator&#xD;
&#xD;
          -  Inadequate washout periods in regards to Environmental Exposure Unit (EEU)&#xD;
             appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2&#xD;
             weeks), intranasal or systemic decongestants (3 days), intranasal or systemic&#xD;
             antihistamines (3 days), loratadine (10 days))&#xD;
&#xD;
          -  Rhinitis medicamentosa&#xD;
&#xD;
          -  Use of long acting anti-histamines&#xD;
&#xD;
          -  Documented evidence of acute or chronic sinusitis as determined by individual&#xD;
             investigator&#xD;
&#xD;
          -  FEV1 lower than 70 % of predicted value&#xD;
&#xD;
          -  Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs&#xD;
             moulds unless symptom free&#xD;
&#xD;
          -  Allergic rhinitis requiring medication caused by allergens other than grass unless&#xD;
             symptom free&#xD;
&#xD;
          -  Subjects with nasal conditions likely to affect the outcome of the study in the&#xD;
             opinion of the investigator, i.e. anterior nasal septum deviation, nasal septum&#xD;
             perforations, nasal polyps, chronic nasal obstruction or other nasal diseases&#xD;
&#xD;
          -  Receipt of immunotherapy with grass pollen within the previous 10 years&#xD;
&#xD;
          -  Women who are breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torben Sigsgaard, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarhus University, School of Public Health, Dept. of Environmental &amp; Occupational Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University, School of Public Health, Department of Environmental &amp; Occupational Medicine</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 18, 2013</last_update_submitted>
  <last_update_submitted_qc>April 18, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rhinitis</keyword>
  <keyword>allergic</keyword>
  <keyword>seasonal</keyword>
  <keyword>double blind</keyword>
  <keyword>doubleblind</keyword>
  <keyword>randomized</keyword>
  <keyword>randomised</keyword>
  <keyword>placebo</keyword>
  <keyword>crossover</keyword>
  <keyword>clinical</keyword>
  <keyword>nasal</keyword>
  <keyword>filter</keyword>
  <keyword>controlled</keyword>
  <keyword>trial</keyword>
  <keyword>hayfever</keyword>
  <keyword>hay</keyword>
  <keyword>fever</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <keyword>prevention</keyword>
  <keyword>adult</keyword>
  <keyword>grass</keyword>
  <keyword>pollen</keyword>
  <keyword>symptom</keyword>
  <keyword>Total nasal symptom score</keyword>
  <keyword>acoustic rhinometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Rhinitis, Allergic, Seasonal</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/NCT01699165
org study id: 1202-2
secondary id: CIV-12-06-007121
secondary id: 1-10-72-371-12.
nct id: NCT01699165
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to assess the effect of reducing exposure to allergens in
      patients with hay fever by means of a nasal filter.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
time frame: Day 1 and day 15
description: To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Nasal Symptom Score (TNSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.
measure: Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
time frame: Day 1 and day 15
description: To assess the effects of active nasal filters on intranasal volume in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter. The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry measurements pre- and post-exposure on each study day. The statistical analysis will be a parametric paired t-test.
measure: To assess symptoms using a VAS Scale symptoms questionnaire (PC)
time frame: Day 1 and Day 15
description: On each study day: pre-exposure and post exposure: 30 minutes post and 3 hours post
measure: To assess the tolerability and safety of nasal filters
time frame: Day 1 and Day 15
description: By means of a product evaluation questionnaire. On each study day evaluated 30 minutes post exposure
measure: To assess the effects on the lower airway via nitrogen oxide measurements during expiration.
time frame: Day 1 and Day 15
description: On each study day: pre-exposure, 30 minutes post exposure and 3 hours post exposure
measure: Spirometric lung function
time frame: Day 1 and Day 15
description: On each study day: pre-exposure, 30 minute post exposure and in 3 hour intervals for 24 hours
measure: Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Ocular Symptom Score (TOSS)
time frame: Day 1 and day 15
description: To assess the effects of active nasal filters on symptoms development in patients with seasonal allergic rhinitis (SAR) exposed to air-born allergens compared to the same patients in an exposed environment with a placebo nasal filter determined by their maximum Total Ocular Symptom Score (TOSS) out of the nine samples taken during a trial day. The statistical analysis will be done using non-parametric paired Wilcoxon signed rank test.
arm group label: Placebo Nasal filter
arm group type: Sham Comparator
description: Placebo treatment
arm group label: Nasal Filter
arm group type: Active Comparator
description: Active treatment
intervention type: Device
intervention name: Nasal filter
description: Active nasal filter
arm group label: Nasal Filter
intervention type: Device
intervention name: Placebo nasal filter
description: Placebo nasal filter
arm group label: Placebo Nasal filter
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Torben Sigsgaard, Professor
role: Principal Investigator
affiliation: Aarhus University, School of Public Health, Dept. of Environmental & Occupational Medicine
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Seasonal