<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/NCT02194062</url>
  </required_header>
  <id_info>
    <org_study_id>1407014259</org_study_id>
    <nct_id>NCT02194062</nct_id>
  </id_info>
  <brief_title>Comparison of Nasal Steroids After FESS in CRSwNP</brief_title>
  <official_title>A Comparison of Budesonide Nasal Irrigation in Different Head Positions and Fluticasone Nasal Spray in Post-operative Functional Endoscopic Sinus Surgery Patients With Chronic Rhinosinusitis With Nasal Polyposis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal&#xD;
      saline rinses in both the upright and head forward positions in patients who have had&#xD;
      functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis&#xD;
      (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-&#xD;
      Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4&#xD;
      months, and 6 months post-op.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and&#xD;
      sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1).&#xD;
      CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus.&#xD;
      Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic&#xD;
      sinus surgery.&#xD;
&#xD;
      Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies&#xD;
      have shown that nasal steroids are superior to placebo in maintaining improvement in symptom&#xD;
      scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal&#xD;
      steroids can reduce inflammation locally and can prevent disease relapse without the systemic&#xD;
      effects of oral steroids. However, there is no consensus as to which nasal steroid and which&#xD;
      delivery method is most effective in treating these patients. Traditional nasal sprays, such&#xD;
      as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide&#xD;
      is available in a respule form that can be used to instill the medication in the nose. In an&#xD;
      attempt to more effectively deliver the medication, changes in patient's head position has&#xD;
      been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more&#xD;
      potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy&#xD;
      over fluticasone nasal spray remains anecdotal as head to head comparisons have not&#xD;
      previously been performed.&#xD;
&#xD;
      Practice patterns among rhinologists in the post-operative prescription of nasal steroids&#xD;
      vary widely. Determining which medication/delivery method is more effective will help&#xD;
      rhinologists better treat their patients and prevent symptoms, for which the surgery was&#xD;
      performed, from returning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SNOT-22 Scores</measure>
    <time_frame>6 months post-op.</time_frame>
    <description>SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lund-Kennedy Scoring for Nasal Endoscopy</measure>
    <time_frame>6 months post-op</time_frame>
    <description>The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Sinusitis</condition>
  <condition>Nasal Polyps</condition>
  <arm_group>
    <arm_group_label>fluticasone nasal spray</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>budesonide respule in head upright</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>budesonide head forward</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluticasone nasal spray</intervention_name>
    <description>use 2-50 mcg sprays to each nostril two times per day</description>
    <arm_group_label>fluticasone nasal spray</arm_group_label>
    <other_name>fluticasone propionate nasal</other_name>
    <other_name>Flonase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide head upright</intervention_name>
    <description>(0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
    <arm_group_label>budesonide respule in head upright</arm_group_label>
    <other_name>budesonide</other_name>
    <other_name>pulmicort respules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide head forward</intervention_name>
    <description>(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day</description>
    <arm_group_label>budesonide head forward</arm_group_label>
    <other_name>budesonide</other_name>
    <other_name>pulmicort respules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who have had FESS for CRSwNP within the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are under the age of 18&#xD;
&#xD;
          2. Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of&#xD;
             prednisone use per day&#xD;
&#xD;
          3. The use of medications that accelerate the clearance of systemic cortisol (Dilantin,&#xD;
             rifampin, amphetamines, and lithium)&#xD;
&#xD;
          4. The use of medications that inhibit the clearance of systemic cortisol (ketoconazole,&#xD;
             amphotericin B, bupropion, fluoroquinolones)&#xD;
&#xD;
          5. Known hypersensitivity to corticosteroids&#xD;
&#xD;
          6. A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal&#xD;
             manifestations&#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>R. Peter Manes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University School of Medicine, Asst Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Physicians Bldg</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale ENT Stratford</name>
      <address>
        <city>Stratford</city>
        <state>Connecticut</state>
        <zip>06614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.</citation>
    <PMID>22469599</PMID>
  </reference>
  <reference>
    <citation>Snidvongs K, Kalish L, Sacks R, Sivasubramaniam R, Cope D, Harvey RJ. Sinus surgery and delivery method influence the effectiveness of topical corticosteroids for chronic rhinosinusitis: systematic review and meta-analysis. Am J Rhinol Allergy. 2013 May-Jun;27(3):221-33. doi: 10.2500/ajra.2013.27.3880.</citation>
    <PMID>23710959</PMID>
  </reference>
  <reference>
    <citation>Beule A, Athanasiadis T, Athanasiadis E, Field J, Wormald PJ. Efficacy of different techniques of sinonasal irrigation after modified Lothrop procedure. Am J Rhinol Allergy. 2009 Jan-Feb;23(1):85-90. doi: 10.2500/ajra.2009.23.3265.</citation>
    <PMID>19379619</PMID>
  </reference>
  <reference>
    <citation>Bhalla RK, Payton K, Wright ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5.</citation>
    <PMID>19128710</PMID>
  </reference>
  <reference>
    <citation>Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555.</citation>
    <PMID>19289711</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>October 19, 2016</results_first_submitted>
  <results_first_submitted_qc>January 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2017</results_first_posted>
  <last_update_submitted>January 12, 2018</last_update_submitted>
  <last_update_submitted_qc>January 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic rhinosinusitis with polyps</keyword>
  <keyword>Nasal steroids</keyword>
  <keyword>Functional endoscopic sinus surgery</keyword>
  <keyword>SNOT-22</keyword>
  <keyword>Lund-Kennedy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Nasal Polyps</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
    <mesh_term>Budesonide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fluticasone Nasal Spray</title>
          <description>Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)&#xD;
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day</description>
        </group>
        <group group_id="P2">
          <title>Budesonide Respule in Head Upright</title>
          <description>Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
        </group>
        <group group_id="P3">
          <title>Budesonide Head Forward</title>
          <description>Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fluticasone Nasal Spray</title>
          <description>Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)&#xD;
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day</description>
        </group>
        <group group_id="B2">
          <title>Budesonide Respule in Head Upright</title>
          <description>Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
        </group>
        <group group_id="B3">
          <title>Budesonide Head Forward</title>
          <description>Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="12"/>
            <count group_id="B4" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" spread="1"/>
                    <measurement group_id="B2" value="44.8" spread="1"/>
                    <measurement group_id="B3" value="39.6" spread="1"/>
                    <measurement group_id="B4" value="43.9" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>asthma</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SNOT-22 Scores</title>
        <description>SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.</description>
        <time_frame>6 months post-op.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Nasal Spray</title>
            <description>Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)&#xD;
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day</description>
          </group>
          <group group_id="O2">
            <title>Budesonide Respule in Head Upright</title>
            <description>Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
          </group>
          <group group_id="O3">
            <title>Budesonide Head Forward</title>
            <description>Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day</description>
          </group>
        </group_list>
        <measure>
          <title>SNOT-22 Scores</title>
          <description>SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" lower_limit="28.35" upper_limit="34.65"/>
                    <measurement group_id="O2" value="10.29" lower_limit="9.59" upper_limit="10.99"/>
                    <measurement group_id="O3" value="15.88" lower_limit="13.78" upper_limit="17.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lund-Kennedy Scoring for Nasal Endoscopy</title>
        <description>The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.</description>
        <time_frame>6 months post-op</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fluticasone Nasal Spray</title>
            <description>Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)&#xD;
fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day</description>
          </group>
          <group group_id="O2">
            <title>Budesonide Respule in Head Upright</title>
            <description>Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
          </group>
          <group group_id="O3">
            <title>Budesonide Head Forward</title>
            <description>Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.&#xD;
Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day</description>
          </group>
        </group_list>
        <measure>
          <title>Lund-Kennedy Scoring for Nasal Endoscopy</title>
          <description>The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" lower_limit="2.06" upper_limit="3.30"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.25" upper_limit="0.74"/>
                    <measurement group_id="O3" value="1.13" lower_limit="0.71" upper_limit="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected over 6 months</time_frame>
      <desc>No difference in definitions for adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fluticasone Group</title>
          <description>Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)</description>
        </group>
        <group group_id="E2">
          <title>Budesonide Respule in Head Upright</title>
          <description>Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day</description>
        </group>
        <group group_id="E3">
          <title>Budesonide Head Forward</title>
          <description>budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small numbers recruited due to time constraints. Not all patients included in final data analysis because of loss to follow up and time constraints of collecting the data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Paul Neubauer</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>2037855430</phone>
      <email>paul.neubauer@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02194062
org study id: 1407014259
nct id: NCT02194062
lead sponsor: 
has dmc: No
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal
      saline rinses in both the upright and head forward positions in patients who have had
      functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis
      (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund-
      Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4
      months, and 6 months post-op.
Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and
      sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1).
      CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus.
      Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic
      sinus surgery.

      Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies
      have shown that nasal steroids are superior to placebo in maintaining improvement in symptom
      scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal
      steroids can reduce inflammation locally and can prevent disease relapse without the systemic
      effects of oral steroids. However, there is no consensus as to which nasal steroid and which
      delivery method is most effective in treating these patients. Traditional nasal sprays, such
      as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide
      is available in a respule form that can be used to instill the medication in the nose. In an
      attempt to more effectively deliver the medication, changes in patient's head position has
      been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more
      potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy
      over fluticasone nasal spray remains anecdotal as head to head comparisons have not
      previously been performed.

      Practice patterns among rhinologists in the post-operative prescription of nasal steroids
      vary widely. Determining which medication/delivery method is more effective will help
      rhinologists better treat their patients and prevent symptoms, for which the surgery was
      performed, from returning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SNOT-22 Scores
time frame: 6 months post-op.
description: SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
measure: Lund-Kennedy Scoring for Nasal Endoscopy
time frame: 6 months post-op
description: The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.
arm group label: fluticasone nasal spray
arm group type: Active Comparator
description: Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
arm group label: budesonide respule in head upright
arm group type: Active Comparator
description: Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
arm group label: budesonide head forward
arm group type: Active Comparator
description: Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
intervention type: Drug
intervention name: fluticasone nasal spray
description: use 2-50 mcg sprays to each nostril two times per day
arm group label: fluticasone nasal spray
other name: fluticasone propionate nasal
other name: Flonase
intervention type: Drug
intervention name: Budesonide head upright
description: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
arm group label: budesonide respule in head upright
other name: budesonide
other name: pulmicort respules
intervention type: Drug
intervention name: Budesonide head forward
description: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
arm group label: budesonide head forward
other name: budesonide
other name: pulmicort respules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: R. Peter Manes, MD
role: Principal Investigator
affiliation: Yale University School of Medicine, Asst Professor
facility: 
facility: 
country: United States
citation: Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
PMID: 22469599
citation: Snidvongs K, Kalish L, Sacks R, Sivasubramaniam R, Cope D, Harvey RJ. Sinus surgery and delivery method influence the effectiveness of topical corticosteroids for chronic rhinosinusitis: systematic review and meta-analysis. Am J Rhinol Allergy. 2013 May-Jun;27(3):221-33. doi: 10.2500/ajra.2013.27.3880.
PMID: 23710959
citation: Beule A, Athanasiadis T, Athanasiadis E, Field J, Wormald PJ. Efficacy of different techniques of sinonasal irrigation after modified Lothrop procedure. Am J Rhinol Allergy. 2009 Jan-Feb;23(1):85-90. doi: 10.2500/ajra.2009.23.3265.
PMID: 19379619
citation: Bhalla RK, Payton K, Wright ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5.
PMID: 19128710
citation: Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555.
PMID: 19289711
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Nasal Polyps
mesh term: Fluticasone
mesh term: Xhance
mesh term: Budesonide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small numbers recruited due to time constraints. Not all patients included in final data analysis because of loss to follow up and time constraints of collecting the data.
point of contact: 