<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/NCT01691677</url>
  </required_header>
  <id_info>
    <org_study_id>MC/PR/1400/007/11</org_study_id>
    <nct_id>NCT01691677</nct_id>
  </id_info>
  <brief_title>beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study</brief_title>
  <acronym>CLEAR</acronym>
  <official_title>Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate Suspension for Inhalation 800 µg Twice Daily vs. Placebo Added to Antibiotic Therapy in Patients With Acute Rhinosinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiesi Farmaceutici S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chiesi Farmaceutici S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As&#xD;
      adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400&#xD;
      μg twice daily, was well tolerated and significantly more effective in reducing the symptoms&#xD;
      of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone&#xD;
      propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical&#xD;
      success rates and accelerated recovery of patients with a history of chronic rhinitis or&#xD;
      recurrent sinusitis who present for treatment of acute rhinosinusitis.&#xD;
&#xD;
      The present study was planned to assess the effects of nebulised beclomethasone dipropionate&#xD;
      given as add-on therapy to standard care (oral antibiotics) in the treatment of acute&#xD;
      symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>proportion of patients who will experience clinical success</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall sinus symptoms</measure>
    <time_frame>7,14,21,28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of each symptom</measure>
    <time_frame>7, 14, 21, 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time</measure>
    <time_frame>7, 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>absence of relapses</measure>
    <time_frame>7, 14, 21, 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nasal mucociliary transport time</measure>
    <time_frame>7, 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nasal air flow resistance</measure>
    <time_frame>7, 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events and adverse drug reactions</measure>
    <time_frame>0, 7, 14, 21, 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vital signs</measure>
    <time_frame>0, 7, 14, 21, 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>Acute Rhinosinusitis</condition>
  <arm_group>
    <arm_group_label>beclomethasone dipropionate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days</intervention_name>
    <arm_group_label>beclomethasone dipropionate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject's written informed consent obtained prior to any study-related procedures&#xD;
&#xD;
          2. Male and female out-patients aged between 18 and 65 years (inclusive).&#xD;
&#xD;
          3. History of previously diagnosed recurrent or chronic sinusitis that necessitate&#xD;
             antibiotic therapy as judged by the investigator.&#xD;
&#xD;
          4. Clinical diagnosis of acute rhinosinusitis defined, according to the European Position&#xD;
             Paper on Rhinosinusitis and Nasal Polyps 2007 (20), as the sudden onset of two or more&#xD;
             relevant symptoms for &lt;12 weeks, at least one of which is:&#xD;
&#xD;
               -  Nasal blockage/obstruction/congestion, OR&#xD;
&#xD;
               -  Nasal discharge (anterior/posterior nasal drip);&#xD;
&#xD;
             AND the second one is:&#xD;
&#xD;
             • Facial pain/pressure or/and reduction/loss of sense of smell.&#xD;
&#xD;
          5. A cooperative attitude and ability to be trained to use correctly the nebuliser with&#xD;
             intranasal nose piece.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous sinus surgery;&#xD;
&#xD;
          2. Sinus lavage within the past 7 days;&#xD;
&#xD;
          3. Nasal polyposis or important nasal septum deviation;&#xD;
&#xD;
          4. Antibiotic use (by any route) in the past 30 days;&#xD;
&#xD;
          5. Recurrent moderate epistaxis;&#xD;
&#xD;
          6. Chronic bacterial sinusitis with evidence of failure of antimicrobial therapy;&#xD;
&#xD;
          7. Intranasal or systemic use of corticosteroids within the past 30 days;&#xD;
&#xD;
          8. Chronic use of corticosteroids or immunosuppressive agents;&#xD;
&#xD;
          9. Immunocompromised states;&#xD;
&#xD;
         10. Diagnosis of bronchial asthma or chronic obstructive pulmonary disease (COPD);&#xD;
&#xD;
         11. History of clinically significant cardiac (i.e. congestive heart failure or severe&#xD;
             hypertension), renal (i.e. kidney failure), psychiatric (i.e. depression or mood&#xD;
             disorders), hepatic (i.e. cholestatic jaundice or hepatic dysfunction), endocrine&#xD;
             (i.e. hyperthyroidism or adrenal suppression) or pulmonary disease, or laboratory&#xD;
             testing abnormalities, whose sequelae and/or treatments can interfere with the results&#xD;
             or treatments of the present study;&#xD;
&#xD;
         12. History of psychiatric diseases likely to require treatment with antidepressant drugs&#xD;
             during the study period or treatment with antidepressant drugs in the past 2 weeks;&#xD;
&#xD;
         13. Diagnosis of glaucoma or prostatic hypertrophy;&#xD;
&#xD;
         14. History of alcohol or drug abuse;&#xD;
&#xD;
         15. Allergy, sensitivity or intolerance to study drugs and/or study drugs formulations&#xD;
             ingredients (e.g. corticosteroids);&#xD;
&#xD;
         16. Pregnant or lactating women or all women physiologically capable of becoming pregnant&#xD;
             UNLESS they meet the following definition of post-menopausal: 12 months of natural&#xD;
             (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels&#xD;
             &gt;40 mIU/mL or are using one or more of the following acceptable methods of&#xD;
             contraception. surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)&#xD;
             hormonal contraception (implantable, patch, oral) double-barrier methods (any double&#xD;
             combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge,&#xD;
             cervical cap). A pregnancy test (urine) will be performed at screening in women of&#xD;
             childbearing potential.&#xD;
&#xD;
         17. Patients unlikely to comply with the protocol or unable to understand the nature,&#xD;
             scope and possible consequences of the study.&#xD;
&#xD;
         18. Participation in another trial in the past 12 weeks or patients previously enrolled in&#xD;
             this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale Cisanello</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Univesitario Gemelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Santa Maria alle Scotte</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-001459-35</url>
    <description>Study Record on EU Clinical Trials Register including results</description>
  </link>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 1, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>March 28, 2017</last_update_submitted>
  <last_update_submitted_qc>March 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Beclomethasone</mesh_term>
  </intervention_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/NCT01691677
org study id: MC/PR/1400/007/11
nct id: NCT01691677
lead sponsor: 
has dmc: No
Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As
      adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400
      μg twice daily, was well tolerated and significantly more effective in reducing the symptoms
      of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone
      propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical
      success rates and accelerated recovery of patients with a history of chronic rhinitis or
      recurrent sinusitis who present for treatment of acute rhinosinusitis.

      The present study was planned to assess the effects of nebulised beclomethasone dipropionate
      given as add-on therapy to standard care (oral antibiotics) in the treatment of acute
      symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: proportion of patients who will experience clinical success
time frame: 28 days
measure: overall sinus symptoms
time frame: 7,14,21,28 days
measure: changes of each symptom
time frame: 7, 14, 21, 28 days
measure: level of work performance based on patient perception (recorded on a VAS scale of the diary card) and on missed working time
time frame: 7, 14 days
measure: absence of relapses
time frame: 7, 14, 21, 28 days
measure: nasal mucociliary transport time
time frame: 7, 14 days
measure: nasal air flow resistance
time frame: 7, 14 days
measure: Adverse events and adverse drug reactions
time frame: 0, 7, 14, 21, 28 days
measure: vital signs
time frame: 0, 7, 14, 21, 28 days
arm group label: beclomethasone dipropionate
arm group type: Experimental
description: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
arm group label: placebo
arm group type: Placebo Comparator
description: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
intervention type: Drug
intervention name: beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days
arm group label: beclomethasone dipropionate
intervention type: Drug
intervention name: placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Italy
url: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2011-001459-35
description: Study Record on EU Clinical Trials Register including results
responsible party type: Sponsor
mesh term: Sinusitis
mesh term: Beclomethasone