<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/NCT02988778</url>
  </required_header>
  <id_info>
    <org_study_id>EF149</org_study_id>
    <nct_id>NCT02988778</nct_id>
  </id_info>
  <brief_title>Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis</brief_title>
  <acronym>RINEX50</acronym>
  <official_title>Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic 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 spray 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 persistent rhinitis moderate to severe in sites&#xD;
      located locally in Brazil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    regulatory strategy&#xD;
  </why_stopped>
  <start_date type="Actual">October 8, 2019</start_date>
  <completion_date type="Actual">October 8, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 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 using the questionnaire Nasal Index Score (NIS)</measure>
    <time_frame>28 days</time_frame>
    <description>Using the questionnaire Nasal Index Score (NIS)</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>Budesonid 50mcg (Noex)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.&#xD;
Treatment of 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Budesonid 50mcg (Busonid)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.&#xD;
Treatment of 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonid 50mcg (Noex)</intervention_name>
    <description>Suspention to nasal use, 2 atomization in each nostril during the morning and at night.</description>
    <arm_group_label>Budesonid 50mcg (Noex)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Budesonid 50mcg (Busonid)</intervention_name>
    <description>Suspention to nasal use, 2 atomization in each nostril during the morning and at night.</description>
    <arm_group_label>Budesonid 50mcg (Busonid)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 12&#xD;
&#xD;
          2. History of allergic persistent rhinitis moderate to severe at least 2 years&#xD;
&#xD;
          3. Proved allergic using PRICK or RAST test&#xD;
&#xD;
          4. Nasal symptoms (NIS) &gt; 3 and nasal obstruction &gt;1&#xD;
&#xD;
          5. Indication of nasal corticosteroids use&#xD;
&#xD;
          6. Washout of nasal corticosteroids for 14 days&#xD;
&#xD;
          7. ICF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other types of rhinitis&#xD;
&#xD;
          2. Asthma non controlled&#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 allergy to any substance of medicines&#xD;
&#xD;
          6. non controlled disease&#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, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Allergisa Pesquisa Dermato-Cosmetica LTDA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alexandra Dumont</name>
      <address>
        <city>Campinas</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 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>
  <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/NCT02988778
org study id: EF149
nct id: NCT02988778
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 spray 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 persistent rhinitis moderate to severe in sites
      located locally in Brazil.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Demonstrate non inferiority of Noex using the questionnaire Nasal Index Score (NIS)
time frame: 28 days
description: Using the questionnaire Nasal Index Score (NIS)
arm group label: Budesonid 50mcg (Noex)
arm group type: Experimental
description: Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
arm group label: Budesonid 50mcg (Busonid)
arm group type: Active Comparator
description: Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day.
Treatment of 28 days.
intervention type: Drug
intervention name: Budesonid 50mcg (Noex)
description: Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
arm group label: Budesonid 50mcg (Noex)
intervention type: Drug
intervention name: Budesonid 50mcg (Busonid)
description: Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
arm group label: Budesonid 50mcg (Busonid)
criteria: 
gender: All
minimum age: 12 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mauro Acir Crippa Junior, MD
role: Principal Investigator
affiliation: Allergisa Pesquisa Dermato-Cosmetica LTDA
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Rhinitis, Allergic, Perennial
sharing ipd: Undecided
ipd description: Undecided, but could be shared upon investigator's request