<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/NCT03028701</url>
  </required_header>
  <id_info>
    <org_study_id>NEU-20.13</org_study_id>
    <nct_id>NCT03028701</nct_id>
  </id_info>
  <brief_title>Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in COPD</brief_title>
  <acronym>COPD</acronym>
  <official_title>Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neutec Ar-Ge San ve Tic A.Ş</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neutec Ar-Ge San ve Tic A.Ş</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective is to asses the bronchodilator effect of single dose of&#xD;
      Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with&#xD;
      COPD.&#xD;
&#xD;
      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different&#xD;
      times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2&#xD;
      hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective is to asses the bronchodilator effect of single dose of&#xD;
      Formoterol/Budesonide 12/400 mcg fixed dose combination delivered via Discair® in patients&#xD;
      with COPD.&#xD;
&#xD;
      Patients will be assigned to receive single dose of Formoterol/Budesonide 12/400 mcg fixed&#xD;
      dose combination delivered via Discair® (test product, n = 33). Patients will be evaluated at&#xD;
      4 consecutive visits: baseline (enrollment), screening, treatment, and end of treatment (24h&#xD;
      after treatment).&#xD;
&#xD;
      For newly diagnosed and formerly diagnosed patients who are not on COPD medication, the&#xD;
      screening visit will be performed on the day of enrollment. For formerly diagnosed patients&#xD;
      receiving COPD treatment, the day of the screening visit will be based on the completion of a&#xD;
      run-in period, with the length determined by the specific medication. During the run-in&#xD;
      period, salbutamol (100 μg inhaler) will be prescribed as a rescue medication.&#xD;
&#xD;
      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different&#xD;
      times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2&#xD;
      hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The time to onset of max improvement from baseline in FEV1.</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period).</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period).</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period).</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1 (AUC0-12) response</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC (AUC0-12) response</measure>
    <time_frame>Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)</time_frame>
    <description>Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of safety</measure>
    <time_frame>Predose and up to 12 hours postdose</time_frame>
    <description>(Physical examination, numbers of adverse reactions and abnormal laboratory values related</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Copd</condition>
  <arm_group>
    <arm_group_label>Formoterol/Budesonide 12/400 mcg Discair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Formoterol/Budesonide 12/400 mcg Discair</intervention_name>
    <description>Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®</description>
    <arm_group_label>Formoterol/Budesonide 12/400 mcg Discair</arm_group_label>
    <other_name>Forpack Discair® Inhalation Powder 12/400 mcg.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged ≥40 years with newly or formerly diagnosed moderate to severe COPD&#xD;
             (Patients with postbronchodilator FEV1/FVC ratio &lt;0.70, and FEV1 &lt;80% of predicted&#xD;
             normal. Patients have chronic cough or chronic productive cough with breathlessness&#xD;
             even walking slowly along flat ground.) Current smokers or exsmokers with a smoking&#xD;
             history of at least 10 pack-years&#xD;
&#xD;
          -  Patients who have no exacerbation within last 4 weeks&#xD;
&#xD;
          -  Females patients with childbearing potential using effective birth control method&#xD;
&#xD;
          -  Patients who has a capability of communicate with investigator&#xD;
&#xD;
          -  Patients who accept to comply with the requirements of the protocol&#xD;
&#xD;
          -  Patients who signed written informed consent prior to participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have history of hypersensitivity to drugs contains long-acting&#xD;
             beta2-agonist or corticosteroids&#xD;
&#xD;
          -  Patients who have abnormal blood glucose level ((≥140 mg/dl)&#xD;
&#xD;
          -  Patients who have unregulated diabetes mellitus&#xD;
&#xD;
          -  Patients who have a serum potassium level of ≤3.5 mEq/L or &gt;5.5mEq/L&#xD;
&#xD;
          -  Patients who have asthma&#xD;
&#xD;
          -  Patients who have a history of myocardial infarction, severe hearth failure, acute&#xD;
             ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least&#xD;
             6 weeks&#xD;
&#xD;
          -  Patients who have lung cancer&#xD;
&#xD;
          -  Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening&#xD;
             visit or during run-in period.&#xD;
&#xD;
          -  Patients who had COPD exacerbation or lower respiratory track infections that required&#xD;
             antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to&#xD;
             screening visit or during run-in period.&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  History of allergic rhinitis or atopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pınar Yıldız, Assoc. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Yildiz P, Bayraktaroglu M, Gorgun D, Yuksel K. Bronchodilator Efficacy of a Single-Dose 12/400-microg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair(R) in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clin Drug Investig. 2019 Oct;39(10):991-1001. doi: 10.1007/s40261-019-00828-y.</citation>
    <PMID>31332649</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Formoterol</keyword>
  <keyword>Budesonide</keyword>
  <keyword>Dry powder inhalation</keyword>
  <keyword>Discair</keyword>
  <keyword>COPD</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Budesonide</mesh_term>
    <mesh_term>Formoterol Fumarate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03028701
org study id: NEU-20.13
nct id: NCT03028701
lead sponsor: 
has dmc: No
The overall objective is to asses the bronchodilator effect of single dose of
      Formoterol/Budesonide 12/400 mcg fixed combination delivered via Discair® in patients with
      COPD.

      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different
      times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2
      hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).
The overall objective is to asses the bronchodilator effect of single dose of
      Formoterol/Budesonide 12/400 mcg fixed dose combination delivered via Discair® in patients
      with COPD.

      Patients will be assigned to receive single dose of Formoterol/Budesonide 12/400 mcg fixed
      dose combination delivered via Discair® (test product, n = 33). Patients will be evaluated at
      4 consecutive visits: baseline (enrollment), screening, treatment, and end of treatment (24h
      after treatment).

      For newly diagnosed and formerly diagnosed patients who are not on COPD medication, the
      screening visit will be performed on the day of enrollment. For formerly diagnosed patients
      receiving COPD treatment, the day of the screening visit will be based on the completion of a
      run-in period, with the length determined by the specific medication. During the run-in
      period, salbutamol (100 μg inhaler) will be prescribed as a rescue medication.

      Spirometric measurements (FEV1, FVC) will be performed for a period of 12 h at 12 different
      times: pretreatment (prior to the first dose) and posttreatment (15. min, 30. min, 1 hr, 2
      hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr ve 12 hr).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: The time to onset of max improvement from baseline in FEV1.
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period).
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period).
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: FEV1 (AUC0-12) response
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: FVC (AUC0-12) response
time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
description: Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
measure: Evaluation of safety
time frame: Predose and up to 12 hours postdose
description: (Physical examination, numbers of adverse reactions and abnormal laboratory values related
arm group label: Formoterol/Budesonide 12/400 mcg Discair
arm group type: Experimental
description: Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
intervention type: Drug
intervention name: Formoterol/Budesonide 12/400 mcg Discair
description: Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
arm group label: Formoterol/Budesonide 12/400 mcg Discair
other name: Forpack Discair® Inhalation Powder 12/400 mcg.
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Pınar Yıldız, Assoc. Prof.
role: Principal Investigator
affiliation: Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital Istanbul, Turkey, 34020
facility: 
country: Turkey
citation: Yildiz P, Bayraktaroglu M, Gorgun D, Yuksel K. Bronchodilator Efficacy of a Single-Dose 12/400-microg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair(R) in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clin Drug Investig. 2019 Oct;39(10):991-1001. doi: 10.1007/s40261-019-00828-y.
PMID: 31332649
responsible party type: Sponsor
mesh term: Budesonide
mesh term: Formoterol Fumarate
sharing ipd: No