<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/NCT02983994</url>
  </required_header>
  <id_info>
    <org_study_id>FPS-INH-2016-01</org_study_id>
    <nct_id>NCT02983994</nct_id>
  </id_info>
  <brief_title>Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma</brief_title>
  <official_title>Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Pública Andaluza Progreso y Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Andalusian Network for Design and Translation of Advanced Therapies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the errors that may occur during inhalation of two&#xD;
      devices in patients with asthma, as well as to study whether it relates to the degree of&#xD;
      control of patient symptoms and the degree of compliance of medication symptoms. Finally, we&#xD;
      also want to study the degree of patient satisfaction with each of the inhalers studied&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">October 10, 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The effectiveness of inhaler management.</measure>
    <time_frame>two months</time_frame>
    <description>The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Patients with asthma with an inhaled steroid</arm_group_label>
    <description>Patients with a diagnosis of asthma with indication of Treatment with an inhaled steroid (CI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with asthma with an inhaled Beta agonist</arm_group_label>
    <description>Patients with a diagnosis of asthma with indication of Treatment with an inhaled Beta agonist (LABA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TURBUHALER®</intervention_name>
    <arm_group_label>Patients with asthma with an inhaled steroid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPIROMAX®</intervention_name>
    <arm_group_label>Patients with asthma with an inhaled Beta agonist</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed as asthma with indication for treatment with an inhaled steroid (IC) and&#xD;
        long-acting beta agonist (LABA), over 18 years of age, will be consecutively included&#xD;
        according to the criteria of the GINA 2015 (Global Strategy for Asthma Management and&#xD;
        Prevention), who have never used dry-powder inhalers, and whose doctor has prescribed one&#xD;
        of the inhalation systems to be studied in the normal practice of the consultation.&#xD;
        Patients will be recruited consecutively to complete the sample size established with each&#xD;
        type of device, in each of the participating centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015&#xD;
             guide and in dry powder device.&#xD;
&#xD;
          -  Over 18 years.&#xD;
&#xD;
          -  Patient in stable phase without having had exacerbations in the 3 months previous to&#xD;
             the Inclusion in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of relevant respiratory disease other than asthma (including COPD).&#xD;
&#xD;
          -  Refusal to participate in the study and sign informed consent or inability to To give&#xD;
             informed consent.&#xD;
&#xD;
          -  Patients who have previously been treated with inhaled dust devices dry.&#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>Hospital Universitario Puerta del Mar</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional de Málaga</name>
      <address>
        <city>Malaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Macarena</name>
      <address>
        <city>Sevilla</city>
        <zip>41092</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma, devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_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/NCT02983994
org study id: FPS-INH-2016-01
nct id: NCT02983994
lead sponsor: 
has dmc: No
The aim of the study is to evaluate the errors that may occur during inhalation of two
      devices in patients with asthma, as well as to study whether it relates to the degree of
      control of patient symptoms and the degree of compliance of medication symptoms. Finally, we
      also want to study the degree of patient satisfaction with each of the inhalers studied
observational model: Other
time perspective: Prospective
measure: The effectiveness of inhaler management.
time frame: two months
description: The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices.
arm group label: Patients with asthma with an inhaled steroid
description: Patients with a diagnosis of asthma with indication of Treatment with an inhaled steroid (CI)
arm group label: Patients with asthma with an inhaled Beta agonist
description: Patients with a diagnosis of asthma with indication of Treatment with an inhaled Beta agonist (LABA)
intervention type: Device
intervention name: TURBUHALER®
arm group label: Patients with asthma with an inhaled steroid
intervention type: Device
intervention name: SPIROMAX®
arm group label: Patients with asthma with an inhaled Beta agonist
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Asthma