<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/NCT01720485</url>
  </required_header>
  <id_info>
    <org_study_id>DPCEMS0812</org_study_id>
    <nct_id>NCT01720485</nct_id>
  </id_info>
  <brief_title>Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment</brief_title>
  <official_title>A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EMS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>EMS</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the non-inferiority clinical efficacy of two&#xD;
      different drug associations in the treatment of Moderate - Severe Persistent Allergic&#xD;
      Rhinitis in Adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</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>Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score</measure>
    <time_frame>7 days</time_frame>
    <description>The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety will be evaluated by the adverse events occurrences</measure>
    <time_frame>7 days</time_frame>
    <description>Adverse events will be collected and followed in order to evaluate safety and tolerability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">234</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>Desloratadine + Prednisolone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will take 2 tablets three times a day, as follows:&#xD;
Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication.&#xD;
Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication.&#xD;
Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexchlorpheniramine + Betamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will take 2 tablets three times a day, as follows:&#xD;
Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.&#xD;
Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.&#xD;
Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Desloratadine + Prednisolone</intervention_name>
    <description>1 tablet 3 times a day</description>
    <arm_group_label>Desloratadine + Prednisolone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexchlorpheniramine + Betamethasone</intervention_name>
    <description>1 tablet 3 times a day</description>
    <arm_group_label>Dexchlorpheniramine + Betamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Consent of the patient;&#xD;
&#xD;
          -  Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA&#xD;
             classification(Allergic Rhinitis and Its Impact on Asthma);&#xD;
&#xD;
          -  Adults aged ≥ 18 years old;&#xD;
&#xD;
          -  Evidence of sensitization to aeroallergens in examination (immediate skin tests or&#xD;
             serum specific IgE) in the 12 months prior to inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Decongestants dependent patients or patients receiving allergen specific&#xD;
             immunotherapy;&#xD;
&#xD;
          -  Patients who were in use of oral antihistamines or decongestants in the past 15 days;&#xD;
&#xD;
          -  Patients who were treated with systemic corticosteroids in the last month;&#xD;
&#xD;
          -  Patients on treatment with monoamine oxidase inhibitors (MAOIs);&#xD;
&#xD;
          -  Patients with history of hypersensitivity to any of the formula compounds;&#xD;
&#xD;
          -  Patients with any clinically significant disease that in the investigator opinion can&#xD;
             not participate in the study&#xD;
&#xD;
          -  Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and&#xD;
             nasal anatomic abnormalities.&#xD;
&#xD;
          -  Participation in clinical trial in 30 days prior to study entry;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IMA - Instituto de Pesquisa Clínica e Medicina Avançada</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Fabio M Castro, MD</last_name>
      <phone>55 11 38639156</phone>
      <email>daniela.fakih@imabrasil.com</email>
    </contact>
    <investigator>
      <last_name>Fabio M Castro, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>September 24, 2013</last_update_submitted>
  <last_update_submitted_qc>September 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2013</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>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Desloratadine</mesh_term>
    <mesh_term>Dexchlorpheniramine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 24, 2015</submitted>
    <returned>September 23, 2015</returned>
    <submitted>March 30, 2021</submitted>
    <returned>April 23, 2021</returned>
  </pending_results>
  <!-- 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/NCT01720485
org study id: DPCEMS0812
nct id: NCT01720485
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two
      different drug associations in the treatment of Moderate - Severe Persistent Allergic
      Rhinitis in Adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
time frame: 7 days
description: The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
measure: Safety will be evaluated by the adverse events occurrences
time frame: 7 days
description: Adverse events will be collected and followed in order to evaluate safety and tolerability
arm group label: Desloratadine + Prednisolone
arm group type: Experimental
description: The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication.
Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
arm group label: Dexchlorpheniramine + Betamethasone
arm group type: Active Comparator
description: The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
intervention type: Drug
intervention name: Desloratadine + Prednisolone
description: 1 tablet 3 times a day
arm group label: Desloratadine + Prednisolone
intervention type: Drug
intervention name: Dexchlorpheniramine + Betamethasone
description: 1 tablet 3 times a day
arm group label: Dexchlorpheniramine + Betamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Prednisolone
mesh term: Betamethasone
mesh term: Desloratadine
mesh term: Dexchlorpheniramine
submitted: August 24, 2015
returned: September 23, 2015
submitted: March 30, 2021
returned: April 23, 2021