<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/NCT04402515</url>
  </required_header>
  <id_info>
    <org_study_id>1237-0096</org_study_id>
    <nct_id>NCT04402515</nct_id>
  </id_info>
  <brief_title>Tiotropium Plus Olodaterol vs Inhaled Corticosteroids (ICS) Regimens in the Portuguese Primary Care Setting (TIOLCOR Study)</brief_title>
  <official_title>Preferences and Consequences in Therapy Decision-making: Tiotropium Bromide Plus Olodaterol vs ICS-containing Regimens in COPD Patients in the Portuguese Primary Care Setting: an Observational, Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      What are the differences between patients prescribed a new maintenance treatment for Chronic&#xD;
      Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled&#xD;
      Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and&#xD;
      clinical characteristics?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    not due to safety reasons&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 28, 2021</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 15, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>N of patients by education level</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>smoking status</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>N of patients by Portugal region</measure>
    <time_frame>up to 4 months</time_frame>
    <description>regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>year of COPD diagnosis</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>comorbidities</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>GOLD 2019 group assessment</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GOLD 2019 grade</measure>
    <time_frame>up to 4 months</time_frame>
    <description>Global Initiative for Chronic Obstructive Lung Disease; grades 1-4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>blood eosinophil count</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio</measure>
    <time_frame>up to 4 months</time_frame>
    <description>FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEV1 % predicted</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>number of COPD exacerbations</measure>
    <time_frame>in the 12 months prior to the index date</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>N of patients with pneumonia</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CAT score</measure>
    <time_frame>up to 4 months</time_frame>
    <description>CAT: COPD Assessment Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Setting in which the COPD treatment was prescribed</measure>
    <time_frame>up to 4 months</time_frame>
    <description>primary vs. hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for COPD treatment change</measure>
    <time_frame>Index date</time_frame>
    <description>Index date is the prescription date of the new or initial COPD maintenance treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for COPD treatment change between the index date and the inclusion visit</measure>
    <time_frame>up to 4 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations</measure>
    <time_frame>Index date</time_frame>
    <description>Index date is the prescription date of the new or initial COPD maintenance treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Quality of Life according to EQ-5D-5L questionnaire</measure>
    <time_frame>up to 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall patient satisfaction with inhaler device according to a 5-point Likert scale</measure>
    <time_frame>up to 4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication</measure>
    <time_frame>up to 4 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Tiotropium plus Olodaterol treatment regimen</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Inhaled corticosteroids-containing treatment regimen</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TIO/OLO</intervention_name>
    <description>Tiotropium/Olodaterol</description>
    <arm_group_label>Tiotropium plus Olodaterol treatment regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ICS</intervention_name>
    <description>inhaled cortocosteroids</description>
    <arm_group_label>Inhaled corticosteroids-containing treatment regimen</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The source population are COPD patients starting a new maintenance COPD treatment with&#xD;
        TIO/OLO or with an ICS-containing regimen in the primary care setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 40 years at the date of COPD diagnosis.&#xD;
&#xD;
          2. Diagnosis of COPD confirmed by the investigator. A spirometry confirming the diagnosis&#xD;
             (FEV1/forced vital capacity [FVC] ratio &lt;0.7) and performed within the three years&#xD;
             prior to the inclusion visit must be available in the patient's medical records.&#xD;
&#xD;
          3. Prescription of a new maintenance COPD treatment with TIO/OLO or ICS-containing&#xD;
             regimens (not including TIO/OLO) 3 months (-7/+30 days) prior to the inclusion visit.&#xD;
             The COPD treatment may have been prescribed at primary care sites or at the hospital.&#xD;
&#xD;
          4. Written informed consent prior to participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Respiratory disorders other than COPD, such as asthma-COPD overlap or asthma (prior to&#xD;
        or at the index date).&#xD;
&#xD;
        2a. For treatment naïve patients (i.e., those who have never started a maintenance therapy&#xD;
        for COPD [with either short- or long-acting bronchodilators or ICS]) - no data on the GOLD&#xD;
        2019 group at the index date is available in the medical records. Patients may still be&#xD;
        included if the determination of the GOLD 2019 group is possible based on the medical&#xD;
        records' data and/or patient interviews (e.g. by using information on exacerbation history&#xD;
        in the 12 months prior to the index date, and data on mMRC and COPD Assessment Test (CAT)&#xD;
        at the index date).&#xD;
&#xD;
        2b. For treatment experienced patients - no data on the predominant treatable trait to&#xD;
        target at the index date (dyspnea, exacerbation or both) is available in the medical&#xD;
        records. Patients may still be included if this information is obtained based on patient&#xD;
        interviews.&#xD;
&#xD;
        3. Participation in a clinical trial within the 3 months prior to the inclusion visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2021</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>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:&#xD;
studies in products where Boehringer Ingelheim is not the license holder;&#xD;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;&#xD;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).&#xD;
For more details refer to: https://www.mystudywindow.com/msw/datasharing</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/NCT04402515
org study id: 1237-0096
nct id: NCT04402515
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
What are the differences between patients prescribed a new maintenance treatment for Chronic
      Obstructive Pulmonary Disease (COPD) with tiotropium/olodaterol (TIO/OLO) or Inhaled
      Corticosteroids (ICS)-containing regimens in terms of sociodemographic, anthropometric and
      clinical characteristics?
observational model: Cohort
time perspective: Prospective
measure: N of patients by education level
time frame: up to 4 months
measure: smoking status
time frame: up to 4 months
measure: BMI
time frame: up to 4 months
measure: N of patients by Portugal region
time frame: up to 4 months
description: regions: North, Center, Lisbon, Alentejo and Algarve (NUTS II)
measure: year of COPD diagnosis
time frame: up to 4 months
measure: comorbidities
time frame: up to 4 months
measure: GOLD 2019 group assessment
time frame: up to 4 months
description: Global Initiative for Chronic Obstructive Lung Disease; groups A, B, C, D
measure: GOLD 2019 grade
time frame: up to 4 months
description: Global Initiative for Chronic Obstructive Lung Disease; grades 1-4
measure: blood eosinophil count
time frame: up to 4 months
measure: post-bronchodilator FEV1/FVC ratio (FEV1/FVC) ratio
time frame: up to 4 months
description: FEV1: Forced expiratory volume in one second; FVC: Forced Vital Capacity
measure: FEV1 % predicted
time frame: up to 4 months
measure: number of COPD exacerbations
time frame: in the 12 months prior to the index date
measure: N of patients with pneumonia
time frame: up to 4 months
measure: Patient symptomatology according to the modified British Medical Research Council (mMRC) questionnaire
time frame: up to 4 months
measure: CAT score
time frame: up to 4 months
description: CAT: COPD Assessment Test
measure: Setting in which the COPD treatment was prescribed
time frame: up to 4 months
description: primary vs. hospital
measure: Reasons for COPD treatment change
time frame: Index date
description: Index date is the prescription date of the new or initial COPD maintenance treatment.
measure: Reasons for COPD treatment change between the index date and the inclusion visit
time frame: up to 4 months
measure: Number of patients for whom the new COPD treatment is in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 Guideline recommendations
time frame: Index date
description: Index date is the prescription date of the new or initial COPD maintenance treatment.
measure: Patient Quality of Life according to EQ-5D-5L questionnaire
time frame: up to 4 months
measure: Overall patient satisfaction with inhaler device according to a 5-point Likert scale
time frame: up to 4 months
measure: Patient satisfaction with treatment according to Treatment Satisfaction Questionnaire for Medication
time frame: up to 4 months
arm group label: Tiotropium plus Olodaterol treatment regimen
arm group label: Inhaled corticosteroids-containing treatment regimen
intervention type: Drug
intervention name: TIO/OLO
description: Tiotropium/Olodaterol
arm group label: Tiotropium plus Olodaterol treatment regimen
intervention type: Drug
intervention name: ICS
description: inhaled cortocosteroids
arm group label: Inhaled corticosteroids-containing treatment regimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
url: https://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datasharing