<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/NCT02972866</url>
  </required_header>
  <id_info>
    <org_study_id>EF148</org_study_id>
    <nct_id>NCT02972866</nct_id>
  </id_info>
  <brief_title>Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis</brief_title>
  <acronym>RINEX32</acronym>
  <official_title>Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eurofarma Laboratorios S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurofarma Laboratorios S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral&#xD;
      Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients&#xD;
      will receive Astrazeneca medication. There is no placebo group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the&#xD;
      intention to collect more data about safety and efficacy and present them to local authority.&#xD;
&#xD;
      This study was draw to treat patients with persisntent rhinits moderate to severe in sites&#xD;
      localted locally in Brasil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Regulatory strategy&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2016</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2019</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.</measure>
    <time_frame>28 days</time_frame>
    <description>The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Rhinitis, Allergic, Perennial</condition>
  <arm_group>
    <arm_group_label>Noex 32mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.&#xD;
Tretament of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Budecort Aqua 32 mcg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.&#xD;
Tretament of 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonide</intervention_name>
    <description>Suspention to nasal use, 2 atomization in each nostril during the morning and at night.</description>
    <arm_group_label>Budecort Aqua 32 mcg</arm_group_label>
    <arm_group_label>Noex 32mcg</arm_group_label>
    <other_name>Noex 32mcg</other_name>
    <other_name>Budecort Aqua 32mcg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 12.&#xD;
&#xD;
          2. History of alergic persistent rhinitis moderate to severe at least 2 years.&#xD;
&#xD;
          3. Proved alergic using PRICK or RAST test.&#xD;
&#xD;
          4. Nasal symptoms (NIS) &gt; 3 and nasal obstruction &gt;1.&#xD;
&#xD;
          5. Indication of nasal corticorteroids use..&#xD;
&#xD;
          6. Washout of nasal corticorteroids for 14 days.&#xD;
&#xD;
          7. ICF.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other types of rhinitis;&#xD;
&#xD;
          2. Asthma non controled&#xD;
&#xD;
          3. Use of oral/injectable corticoids 30 days before screening.&#xD;
&#xD;
          4. patients not eligible to complete diaries.&#xD;
&#xD;
          5. patients with alergy to any substance of medicines.&#xD;
&#xD;
          6. non controlled desease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Acir Crippa Junior</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergisa Pesquisa Dermato-Cosmética Ltda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allergisa pesquisa dermato-cosmética ltda</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</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>
    <mesh_term>Rhinitis, Allergic, Perennial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided, but could be shared upon investigator's request.</ipd_description>
  </patient_data>
  <!-- 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/NCT02972866
org study id: EF148
nct id: NCT02972866
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral
      Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients
      will receive Astrazeneca medication. There is no placebo group.
Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the
      intention to collect more data about safety and efficacy and present them to local authority.

      This study was draw to treat patients with persisntent rhinits moderate to severe in sites
      localted locally in Brasil.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Demonstrate non inferiority of Noex comparable with referral product Budecort Aqua in the treatment of rinithis moderate to severe during 4 weeks of treatment.
time frame: 28 days
description: The questionnaire Nasal Index Score (NIS) will be used to check intensity of symptons and patient will answer this questionnaire daily at home.
arm group label: Noex 32mcg
arm group type: Experimental
description: Noex/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days.
arm group label: Budecort Aqua 32 mcg
arm group type: Experimental
description: Budecort Aqua/Budesonide 32mcg, 2 atomizations in each nostril by the morning and during the night, total of 256 mcg per day.
Tretament of 28 days.
intervention type: Drug
intervention name: Budesonide
description: Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
arm group label: Budecort Aqua 32 mcg
arm group label: Noex 32mcg
other name: Noex 32mcg
other name: Budecort Aqua 32mcg
criteria: 
gender: All
minimum age: 12 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mauro Acir Crippa Junior
role: Principal Investigator
affiliation: Allergisa Pesquisa Dermato-Cosmética Ltda
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
mesh term: Budesonide
sharing ipd: Undecided
ipd description: Undecided, but could be shared upon investigator's request.