<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/NCT01676415</url>
  </required_header>
  <id_info>
    <org_study_id>18369</org_study_id>
    <nct_id>NCT01676415</nct_id>
  </id_info>
  <brief_title>Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)</brief_title>
  <official_title>Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the most effective route to administer steroids to&#xD;
      patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with&#xD;
      nasal polyps (CRSsNP). The investigators would like to better understand whether orally&#xD;
      administered steroids results in superior results when compared with nasally sprayed&#xD;
      steroids. The investigators propose to test the hypothesis that for patients with&#xD;
      radiographically proven CRSsNP, routine medical therapy consisting of a short course of&#xD;
      systemic corticosteroids is superior to topical corticosteroids for relieving inflammation&#xD;
      and the symptoms of CRS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic sinus infections (chronic sinusitis or CRS) are common conditions that affect&#xD;
      millions of Americans. While this is a common disorder, medical treatments for this condition&#xD;
      vary a lot and little is known how and why different treatments work in some individuals and&#xD;
      not in others. Some physicians commonly utilize a course of oral steroid therapy similar to&#xD;
      treatment of inflammatory conditions including asthma and arthritis. Other physicians feel&#xD;
      that oral steroids are not more effective than nasal steroid sprays in reducing inflammation&#xD;
      and prefer prescribing nasal steroids. There is no conclusive data as to whether oral or&#xD;
      sprayed nasal steroids are more effective in providing long-term benefit to patients. Nasal&#xD;
      steroids are FDA approved to treat some types of chronic sinusitis but oral steroids are FDA&#xD;
      approved medications that are used to treat inflammatory conditions but is not specifically&#xD;
      indicated for chronic sinusitis and thus should be regarded as investigational drug. The&#xD;
      purpose of this research study is to better understand whether orally administered steroids&#xD;
      results in superior results when compared with nasally sprayed steroids. The investigators&#xD;
      will compare patients with chronic sinusitis who are first treated with antibiotics and oral&#xD;
      steroids, and compare them to chronic sinusitis patients who receive antibiotics and nasally&#xD;
      sprayed steroid therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    participants are no longer receiving intervention due to clinical logistics&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>Phase 4</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 Questionnaire</measure>
    <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
    <description>The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (&quot;nasal obstruction&quot; and &quot;loss of smell and taste&quot;) ranked from 0 (not a problem) to 5 (problem as bad as it can be).&#xD;
Min score= 0, Max score= 110 (&quot;worst possible problem&quot; on all symptoms)&#xD;
Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lund-McKay Score From CT Scan</measure>
    <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
    <description>Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Taskforce Symptom Inventory</measure>
    <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
    <description>Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Side-effect and Compliance Inventory</measure>
    <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
    <description>The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Chronic Rhinosinusitis Without Nasal Polyps</condition>
  <arm_group>
    <arm_group_label>Prednisone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral steroid medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical Mometasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical steroid medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
    <arm_group_label>Prednisone</arm_group_label>
    <other_name>Glucocorticoid</other_name>
    <other_name>Deltasone</other_name>
    <other_name>Liquid Pred</other_name>
    <other_name>Meticorten</other_name>
    <other_name>Orasone</other_name>
    <other_name>Prednicen-M</other_name>
    <other_name>Prednicot</other_name>
    <other_name>Sterapred</other_name>
    <other_name>Sterapred DS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical mometasone</intervention_name>
    <description>Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
    <arm_group_label>Topical Mometasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. They have three-months of persistent symptoms meeting criteria for chronic&#xD;
             rhinosinusitis as defined by the Taskforce on Rhinosinusitis.&#xD;
&#xD;
          2. They have a CT-scan in our clinic or have a viewable recent (&lt; 3weeks prior to clinic&#xD;
             visit) CT-scan with a Lund Mckay score of 6 or greater. A Lund Mckay score of 6 or&#xD;
             greater is felt to be indicative of at least moderate CRS.&#xD;
&#xD;
          3. They do not have nasal polyps on initial clinic nasal endoscopy&#xD;
&#xD;
          4. They are willing to participate in a clinical study&#xD;
&#xD;
          5. They are between the ages of 18 to 80.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. They have a condition in which the use of systemic corticosteroids is contraindicated&#xD;
             such as diabetes will be excluded.&#xD;
&#xD;
          2. They are unable to or unwilling to take the prescribed antibiotics or steroids will&#xD;
             excluded.&#xD;
&#xD;
          3. They have been treated with a &gt; 3 week course of antibiotics and/or systemic steroids&#xD;
             will also be excluded.&#xD;
&#xD;
          4. They have variants of chronic sinusitis known to be refractory to medical therapy such&#xD;
             as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.&#xD;
&#xD;
          5. They have sinusitis secondary to prior surgery, a dental procedure or anatomical&#xD;
             variants.&#xD;
&#xD;
          6. They have nasal polyps on physical exam.&#xD;
&#xD;
          7. They are pregnant. Subjects who are possibly pregnant will be excluded based on&#xD;
             history. Pregnancy testing is not standard of care for diagnostic imaging.&#xD;
&#xD;
          8. They have a Lund-Mckay score on CT scan of &lt; 6&#xD;
&#xD;
          9. They are &lt; 18 or &gt; 80 years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruce Tan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>: Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.northwestern-sinus.com/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.</citation>
    <PMID>16815148</PMID>
  </reference>
  <reference>
    <citation>Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.</citation>
    <PMID>17903570</PMID>
  </reference>
  <reference>
    <citation>Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.</citation>
    <PMID>19793277</PMID>
  </reference>
  <reference>
    <citation>Parikh A, Scadding GK, Darby Y, Baker RC. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray. Rhinology. 2001 Jun;39(2):75-9.</citation>
    <PMID>11486442</PMID>
  </reference>
  <reference>
    <citation>Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.</citation>
    <PMID>12862401</PMID>
  </reference>
  <reference>
    <citation>Wallwork B, Coman W, Mackay-Sim A, Greiff L, Cervin A. A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope. 2006 Feb;116(2):189-93. doi: 10.1097/01.mlg.0000191560.53555.08.</citation>
    <PMID>16467702</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>January 27, 2017</results_first_submitted>
  <results_first_submitted_qc>March 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 8, 2017</results_first_posted>
  <last_update_submitted>March 28, 2018</last_update_submitted>
  <last_update_submitted_qc>March 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Bruce Tan</investigator_full_name>
    <investigator_title>MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Sinus disease</keyword>
  <keyword>Sinonasal complaints</keyword>
  <keyword>Chronic sinusitis</keyword>
  <keyword>Nasal polyps</keyword>
  <keyword>Chronic rhinosinusitis without nasal polyps</keyword>
  <keyword>Glucocorticoids</keyword>
  <keyword>Prednisone</keyword>
  <keyword>Topical mometasone</keyword>
  <keyword>Anti-inflammatory agents</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>
    <mesh_term>Polyps</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mometasone Furoate</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Prednisone</title>
          <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
        </group>
        <group group_id="P2">
          <title>Topical Mometasone</title>
          <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prednisone</title>
          <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
        </group>
        <group group_id="B2">
          <title>Topical Mometasone</title>
          <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
        </group>
        <group group_id="B3">
          <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="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="46.7" spread="16.5"/>
                    <measurement group_id="B2" value="45.9" spread="11.5"/>
                    <measurement group_id="B3" value="46.3" spread="14.3"/>
                  </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="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SNOT-22 Questionnaire</title>
        <description>The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (&quot;nasal obstruction&quot; and &quot;loss of smell and taste&quot;) ranked from 0 (not a problem) to 5 (problem as bad as it can be).&#xD;
Min score= 0, Max score= 110 (&quot;worst possible problem&quot; on all symptoms)&#xD;
Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.</description>
        <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
          </group>
          <group group_id="O2">
            <title>Topical Mometasone</title>
            <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>SNOT-22 Questionnaire</title>
          <description>The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (&quot;nasal obstruction&quot; and &quot;loss of smell and taste&quot;) ranked from 0 (not a problem) to 5 (problem as bad as it can be).&#xD;
Min score= 0, Max score= 110 (&quot;worst possible problem&quot; on all symptoms)&#xD;
Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-6 WEEKS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.75" spread="6.7"/>
                    <measurement group_id="O2" value="34.4" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 MONTHS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" spread="9.3"/>
                    <measurement group_id="O2" value="34.4" spread="8.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lund-McKay Score From CT Scan</title>
        <description>Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.</description>
        <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
        <population>Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
          </group>
          <group group_id="O2">
            <title>Topical Mometasone</title>
            <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Lund-McKay Score From CT Scan</title>
          <description>Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.</description>
          <population>Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Taskforce Symptom Inventory</title>
        <description>Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.</description>
        <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
        <population>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
          </group>
          <group group_id="O2">
            <title>Topical Mometasone</title>
            <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Taskforce Symptom Inventory</title>
          <description>Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.</description>
          <population>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medication Side-effect and Compliance Inventory</title>
        <description>The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.</description>
        <time_frame>4-6 weeks and 3 months after initiation of treatment</time_frame>
        <population>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Prednisone</title>
            <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
          </group>
          <group group_id="O2">
            <title>Topical Mometasone</title>
            <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Medication Side-effect and Compliance Inventory</title>
          <description>The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.</description>
          <population>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected over 3 months that patients were enrolled in the study.</time_frame>
      <desc>The definition of adverse events/serious adverse events do not differ from the Clinical Trials definition. None of the patients in this study had an adverse event or serious adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Prednisone</title>
          <description>Oral steroid medication&#xD;
Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days&#xD;
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study</description>
        </group>
        <group group_id="E2">
          <title>Topical Mometasone</title>
          <description>Topical steroid medication&#xD;
Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily&#xD;
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead&#xD;
Antihistamines if an appropriate history of atopy is obtained&#xD;
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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>Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>BRUCE TAN</name_or_title>
      <organization>NORTHWESTERN UNIVERSITY</organization>
      <phone>3126958182</phone>
      <email>CPRICE2@NM.ORG</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/NCT01676415
org study id: 18369
nct id: NCT01676415
lead sponsor: 
The purpose of this study is to determine the most effective route to administer steroids to
      patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with
      nasal polyps (CRSsNP). The investigators would like to better understand whether orally
      administered steroids results in superior results when compared with nasally sprayed
      steroids. The investigators propose to test the hypothesis that for patients with
      radiographically proven CRSsNP, routine medical therapy consisting of a short course of
      systemic corticosteroids is superior to topical corticosteroids for relieving inflammation
      and the symptoms of CRS.
Chronic sinus infections (chronic sinusitis or CRS) are common conditions that affect
      millions of Americans. While this is a common disorder, medical treatments for this condition
      vary a lot and little is known how and why different treatments work in some individuals and
      not in others. Some physicians commonly utilize a course of oral steroid therapy similar to
      treatment of inflammatory conditions including asthma and arthritis. Other physicians feel
      that oral steroids are not more effective than nasal steroid sprays in reducing inflammation
      and prefer prescribing nasal steroids. There is no conclusive data as to whether oral or
      sprayed nasal steroids are more effective in providing long-term benefit to patients. Nasal
      steroids are FDA approved to treat some types of chronic sinusitis but oral steroids are FDA
      approved medications that are used to treat inflammatory conditions but is not specifically
      indicated for chronic sinusitis and thus should be regarded as investigational drug. The
      purpose of this research study is to better understand whether orally administered steroids
      results in superior results when compared with nasally sprayed steroids. The investigators
      will compare patients with chronic sinusitis who are first treated with antibiotics and oral
      steroids, and compare them to chronic sinusitis patients who receive antibiotics and nasally
      sprayed steroid therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SNOT-22 Questionnaire
time frame: 4-6 weeks and 3 months after initiation of treatment
description: The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be).
Min score= 0, Max score= 110 ("worst possible problem" on all symptoms)
Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.
measure: Lund-McKay Score From CT Scan
time frame: 4-6 weeks and 3 months after initiation of treatment
description: Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.
measure: Taskforce Symptom Inventory
time frame: 4-6 weeks and 3 months after initiation of treatment
description: Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.
measure: Medication Side-effect and Compliance Inventory
time frame: 4-6 weeks and 3 months after initiation of treatment
description: The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.
arm group label: Prednisone
arm group type: Active Comparator
description: Oral steroid medication
arm group label: Topical Mometasone
arm group type: Active Comparator
description: Topical steroid medication
intervention type: Drug
intervention name: Prednisone
description: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study
arm group label: Prednisone
other name: Glucocorticoid
other name: Deltasone
other name: Liquid Pred
other name: Meticorten
other name: Orasone
other name: Prednicen-M
other name: Prednicot
other name: Sterapred
other name: Sterapred DS
intervention type: Drug
intervention name: Topical mometasone
description: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
Antihistamines if an appropriate history of atopy is obtained
Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study.
arm group label: Topical Mometasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bruce Tan, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
url: http://www.northwestern-sinus.com/
description: Related Info
citation: Hissaria P, Smith W, Wormald PJ, Taylor J, Vadas M, Gillis D, Kette F. Short course of systemic corticosteroids in sinonasal polyposis: a double-blind, randomized, placebo-controlled trial with evaluation of outcome measures. J Allergy Clin Immunol. 2006 Jul;118(1):128-33. doi: 10.1016/j.jaci.2006.03.012. Epub 2006 May 19.
PMID: 16815148
citation: Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
PMID: 17903570
citation: Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
PMID: 19793277
citation: Parikh A, Scadding GK, Darby Y, Baker RC. Topical corticosteroids in chronic rhinosinusitis: a randomized, double-blind, placebo-controlled trial using fluticasone propionate aqueous nasal spray. Rhinology. 2001 Jun;39(2):75-9.
PMID: 11486442
citation: Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
PMID: 12862401
citation: Wallwork B, Coman W, Mackay-Sim A, Greiff L, Cervin A. A double-blind, randomized, placebo-controlled trial of macrolide in the treatment of chronic rhinosinusitis. Laryngoscope. 2006 Feb;116(2):189-93. doi: 10.1097/01.mlg.0000191560.53555.08.
PMID: 16467702
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Bruce Tan
investigator title: MD, Assistant Professor, Dept of Otolaryngology, Northwestern University Feinberg School of Medicine
mesh term: Sinusitis
mesh term: Nasal Polyps
mesh term: Polyps
mesh term: Mometasone Furoate
mesh term: Prednisone
mesh term: Glucocorticoids
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.
point of contact: 