xml: <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/NCT06029595</url>
    </required_header>
    <id_info>
      <org_study_id>CLI-06001AA2-01</org_study_id>
      <secondary_id>EUCT: 2022-502208-64-00</secondary_id>
      <nct_id>NCT06029595</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy</brief_title>
    <acronym>TANGO</acronym>
    <official_title>A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chiesi Farmaceutici S.p.A.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chiesi Farmaceutici S.p.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>
        The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as&#xD;
        add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists&#xD;
        in the target patient population. (TANGO)&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 28, 2023</start_date>
    <completion_date type="Anticipated">December 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 18, 2025</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Randomised, double-blind, placebo-controlled, 2-arm parallel group study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double (Participant, Investigator)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Asthma exacerbation over 52 weeks of treatment</measure>
      <time_frame>Over 52 weeks</time_frame>
      <description>Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to first asthma exacerbation;</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of asthma exacerbation and asthma worsening over 52 weeks of treatment</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to first asthma exacerbation or asthma worsening</measure>
      <time_frame>Up to 52 weeks</time_frame>
      <description>Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ACQ-7 responders</measure>
      <time_frame>week 4, week 26 and week 52</time_frame>
      <description>ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units);</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in ACQ-7 and ACQ-6</measure>
      <time_frame>week 4, week 26 and week 52</time_frame>
      <description>Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in Mini-AQLQ</measure>
      <time_frame>week 4, week 26 and week 52</time_frame>
      <description>Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in pre-dose FEV1</measure>
      <time_frame>week 4, week 26 and week 52</time_frame>
      <description>Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in pre-dose FVC</measure>
      <time_frame>Week4, Week 52 and Week 26</time_frame>
      <description>Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.</measure>
      <time_frame>Up to 52 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">464</enrollment>
    <condition>Uncontrolled Asthma</condition>
    <arm_group>
      <arm_group_label>CHF6001 - CHF6001 total daily dose 3200 μg;</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Experimental: CHF6001 3200 μg</intervention_name>
      <description>800 μg/actuation - 2 inhalations of CHF6001 800 μg twice daily (BID) total daily dose 3200 μg</description>
      <arm_group_label>CHF6001 - CHF6001 total daily dose 3200 μg;</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Comparator: CHF6001 Placebo</intervention_name>
      <description>2 inhalations of CHF6001 matching placebo BID</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subject's written informed consent&#xD;
  &#xD;
            2. Male or female subjects aged ≥18 and ≤75 years&#xD;
  &#xD;
            3. A documented history of physician-diagnosed asthma for at least 1 year and with&#xD;
               diagnosis before the age of 50 years&#xD;
  &#xD;
            4. Stable asthma therapy: a stable maintenance treatment with medium to high dose of&#xD;
               inhaled corticosteroids plus long acting β2 agonists for at least 3 months prior to&#xD;
               screening&#xD;
  &#xD;
            5. A prebronchodilator FEV1 ≤80% of the predicted normal value&#xD;
  &#xD;
            6. Bronchodilator responsiveness after inhalation of salbutamol or equivalent&#xD;
  &#xD;
            7. Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score ≥1.5&#xD;
  &#xD;
            8. History of asthma exacerbations : at least 1 asthma exacerbation leading to&#xD;
               hospitalisation or 2 or more asthma exacerbations within the last 12 months&#xD;
  &#xD;
            9. A cooperative attitude and ability to use inhalers and to comply with study procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. e-Diary completion compliance &lt;75% during run-in&#xD;
  &#xD;
            2. History of near fatal asthma or of a past hospitalisation for asthma in intensive care&#xD;
               unit&#xD;
  &#xD;
            3. Recent exacerbation or respiratory tract infection within 4 weeks prior to screening&#xD;
               visit or during the run-in period&#xD;
  &#xD;
            4. Subjects using systemic corticosteroids medication in the 4 weeks or slow-release&#xD;
               corticosteroids in the 12 weeks prior to randomisation&#xD;
  &#xD;
            5. Asthma requiring use of biologics&#xD;
  &#xD;
            6. Respiratory disorders other than asthma: subjects with known respiratory disorders&#xD;
               other than asthma&#xD;
  &#xD;
            7. Subjects with a history of lung volume resection&#xD;
  &#xD;
            8. Current smokers, ex-smokers with a smoking history of ≥10 pack-years or current use of&#xD;
               inhaled or oral cannabis products.&#xD;
  &#xD;
            9. Subjects with cancer or history of cancer&#xD;
  &#xD;
           10. Subjects with cardiovascular diseases&#xD;
  &#xD;
           11. Subjects with any abnormal and clinically significant 12-lead ECG&#xD;
  &#xD;
           12. Subjects with previous medical history, evidence of an uncontrolled intercurrent&#xD;
               illness, or any clinically relevant abnormal findings in haematology, clinical&#xD;
               chemistry, or urinalysis&#xD;
  &#xD;
           13. Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal&#xD;
               ideation or behaviour&#xD;
  &#xD;
           14. Patients mentally or legally incapacitated or patients accommodated in an&#xD;
               establishment&#xD;
  &#xD;
           15. Subjects with liver diseases&#xD;
  &#xD;
           16. Drugs with hepatoxicity potential&#xD;
  &#xD;
           17. Subjects with contra-indications to IMPs:&#xD;
  &#xD;
           18. Subjects with history alcohol/drug abuse&#xD;
  &#xD;
           19. Subjects with major surgery in the 3 months prior to screening visit or planned during&#xD;
               the trial&#xD;
  &#xD;
           20. Subjects treated with non-potassium sparing diuretics, nonselective β-blocking drugs,&#xD;
               quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation&#xD;
               potential or a history of QTc prolongation&#xD;
  &#xD;
           21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic&#xD;
               anti-depressants&#xD;
  &#xD;
           22. Subjects receiving any therapy that could interfere with the study drugs&#xD;
  &#xD;
           23. Participation in another investigational trial&#xD;
  &#xD;
           24. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks&#xD;
  &#xD;
           25. Subjects having received a vaccination within 2 weeks prior to screening or during the&#xD;
               run-in period.&#xD;
  &#xD;
           26. For females only: pregnant or lactating women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Johann Christian VIRCHOW, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitätsmedizin Rostock</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chiesi Clinical Trial info</last_name>
      <phone>+3905212791</phone>
      <email>clinicaltrials_info@chiesi.Com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Asthma</keyword>
    <keyword>PDE4 inhibitor</keyword>
    <keyword>anti-inflammatory respiratory drug</keyword>
    <keyword>Tanimilast</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029595
  org study id: CLI-06001AA2-01
  secondary id: EUCT: 2022-502208-64-00
  nct id: NCT06029595
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as
        add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists
        in the target patient population. (TANGO)
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomised, double-blind, placebo-controlled, 2-arm parallel group study
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Double (Participant, Investigator)
  measure: Number of Asthma exacerbation over 52 weeks of treatment
  time frame: Over 52 weeks
  description: Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)
  measure: Time to first asthma exacerbation;
  time frame: Up to 52 weeks
  description: Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization
  measure: Number of asthma exacerbation and asthma worsening over 52 weeks of treatment
  time frame: Up to 52 weeks
  description: Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.
  measure: Time to first asthma exacerbation or asthma worsening
  time frame: Up to 52 weeks
  description: Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.
  measure: ACQ-7 responders
  time frame: week 4, week 26 and week 52
  description: ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of ≥0.5 units);
  measure: Change from baseline in ACQ-7 and ACQ-6
  time frame: week 4, week 26 and week 52
  description: Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52
  measure: Change from baseline in Mini-AQLQ
  time frame: week 4, week 26 and week 52
  description: Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52
  measure: Change from baseline in pre-dose FEV1
  time frame: week 4, week 26 and week 52
  description: Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;
  measure: Change from baseline in pre-dose FVC
  time frame: Week4, Week 52 and Week 26
  description: Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;
  measure: Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;
  time frame: Up to 52 weeks
  measure: Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score
  time frame: Up to 52 weeks
  measure: Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.
  time frame: Up to 52 weeks
  arm group label: CHF6001 - CHF6001 total daily dose 3200 μg;
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Experimental: CHF6001 3200 μg
  description: 800 μg/actuation - 2 inhalations of CHF6001 800 μg twice daily (BID) total daily dose 3200 μg
  arm group label: CHF6001 - CHF6001 total daily dose 3200 μg;
  intervention type: Drug
  intervention name: Placebo Comparator: CHF6001 Placebo
  description: 2 inhalations of CHF6001 matching placebo BID
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Johann Christian VIRCHOW, Prof
  role: Principal Investigator
  affiliation: Universitätsmedizin Rostock
  last name: Chiesi Clinical Trial info
  phone: +3905212791
  email: clinicaltrials_info@chiesi.Com
  responsible party type: Sponsor
  mesh term: Asthma
  sharing ipd: No