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/NCT06040424</url>
    </required_header>
    <id_info>
      <org_study_id>NEU-01.22</org_study_id>
      <nct_id>NCT06040424</nct_id>
    </id_info>
    <brief_title>Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients</brief_title>
    <official_title>Randomized, Parallel Group, Phase III, Non-inferiority Study Comparing Ipratropium / Levosalbutamol Fixed Dose Combination in pMDI Form and Ipratropium and Salbutamol Free Dose Combination in pMDI Form in Stable 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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the acute bronchodilator effect of pMDI formed&#xD;
        Ipratropium / Levosalbutamol 20 mcg / 50 mcg fixed dose combination or pMDI formed Salbutamol&#xD;
        100 mcg Inhaler and Ipratropium 20 mcg Inhalation Aerosol in combination in stable&#xD;
        moderate-severe-very severe COPD patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>
      <intervention_model_description>Randomized, Parallel Group, Phase III, Non-inferiority Study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h)</measure>
      <time_frame>8 hours</time_frame>
      <description>Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)</measure>
      <time_frame>3 hours</time_frame>
      <description>Change From Baseline in FEV1 AUC (0-3h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEV1 AUC 3-6 h</measure>
      <time_frame>3 to 6 hours</time_frame>
      <description>Change From Baseline in FEV1 AUC (3-6h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FEV1 AUC 6-8 h</measure>
      <time_frame>6 to 8 hours</time_frame>
      <description>Change From Baseline in FEV1 AUC (6-8h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC AUC 0-3 h</measure>
      <time_frame>3 hours</time_frame>
      <description>Change From Baseline in FVC AUC (0-3h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC AUC 3-6 h</measure>
      <time_frame>3 to 6 hours</time_frame>
      <description>Change From Baseline in FVC AUC (3-6h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC AUC 6-8 h</measure>
      <time_frame>6 to 8 hours</time_frame>
      <description>Change From Baseline in FVC AUC (6-8h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>FVC AUC 0-8 h</measure>
      <time_frame>0 to 8 hours</time_frame>
      <description>Change From Baseline in FVC AUC (0-8h).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in FEV1 and FVC within the first 30 minutes after dosing (mL)</measure>
      <time_frame>Baseline, 30 minutes post-dose at treatment day</time_frame>
      <description>Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Maximum Change From Baseline in FEV1 and FVC within the first 1 hours after dosing (mL)</measure>
      <time_frame>Baseline, 1 hours post-dose at treatment day</time_frame>
      <description>Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours (mL)</measure>
      <time_frame>Baseline, 0 to 8 hours post-dose at treatment day</time_frame>
      <description>Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Time to Onset of Bronchodilator Response</measure>
      <time_frame>Baseline, 0 to 8 hours post-dose at treatment day</time_frame>
      <description>Bronchodilator response is defined as 100 mL improvement in FEV1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of Safety</measure>
      <time_frame>Baseline, 0 to 24 hours post-dose</time_frame>
      <description>Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>COPD</condition>
    <arm_group>
      <arm_group_label>Ipratropium / Levosalbutamol Fixed Dose Combination</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this one-day study, patients will be administered 2 inhalation of &quot;İPRALEV 20 mcg/50 mcg aerosol inhalasyonu, süspansiyon&quot; at morning.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ipratropium + Levosalbutamol Free Dose Combination</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this one-day study, patients will be administered 2 inhalations of &quot;VENTOLİN İnhaler 100 mcg&quot; and then 2 inhalations of &quot;ATROVENT MDI 0,02 mg/dose&quot; at morning.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Ipratropium / Levosalbutamol Fixed Dose Combination</intervention_name>
      <description>New combination test treatment</description>
      <arm_group_label>Ipratropium / Levosalbutamol Fixed Dose Combination</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ipratropium + Levosalbutamol Free Dose Combination</intervention_name>
      <description>Free combination control treatment</description>
      <arm_group_label>Ipratropium + Levosalbutamol Free Dose Combination</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female patients aged 40 years and older who have been newly diagnosed or&#xD;
               followed up with a diagnosis of COPD.&#xD;
  &#xD;
            -  Stable moderate-severe-very severe COPD patients with a post-bronchodilator FEV1/FVC&#xD;
               ratio &lt;70% and a postbronchodilator FEV1 value &lt;80% at the screening visit will be&#xD;
               included in the study.&#xD;
  &#xD;
            -  Symptom status such as chronic cough, sputum production, and progressive dyspnea with&#xD;
               the BCSS (Breathlessness, Cough and Sputum Scale) Index will be evaluated, and the&#xD;
               COPD staging of the patient with CAT (COPD Assessment Test) and the severity of&#xD;
               dyspnea with mMRC (Modified Medical Research Council) will be determined.&#xD;
  &#xD;
            -  Patients with at least 10 pack/year smoking status or smoking history (patients who&#xD;
               have quit smoking for at least 6 months or more are defined as ex-smokers).&#xD;
  &#xD;
            -  Patients who have not experienced an exacerbation in the previous 4 weeks.&#xD;
  &#xD;
            -  If the study participant is female; women using appropriate contraception (pregnancy&#xD;
               test will be performed at screening visit).&#xD;
  &#xD;
            -  Patients with the ability to communicate with the investigator.&#xD;
  &#xD;
            -  Patients who accept to comply with the protocol.&#xD;
  &#xD;
            -  Patients who sign written informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of hypersensitivity to anticholinergics or SABAs (short acting beta agonist).&#xD;
  &#xD;
            -  History of COPD exacerbation or lower respiratory track infection that required&#xD;
               treatment with antibiotic, oral or parenteral corticosteroid within the last 3 days&#xD;
               prior the screening visit or during the run-in/wash-out period or history of&#xD;
               respiratory tract infection that required treatment with antibiotic within the last 14&#xD;
               days prior the screening visit.&#xD;
  &#xD;
            -  Hospitalization due to COPD or pneumonia within the last 3 mounts prior the screening&#xD;
               visit.&#xD;
  &#xD;
            -  SGOT (serum glutamic-oxaloacetic transaminase) &gt;80 IU/L, SGPT (serum glutamic-pyruvic&#xD;
               transaminase) &gt;80 IU/L, bilirubin &gt;2.0 mg/dL or creatinine &gt;2.0 mg/dL.&#xD;
  &#xD;
            -  History of asthma, significant chronic respiratory diseases (i.e., significant&#xD;
               bronchiectasis, interstitial lung diseases, etc.) other than COPD or presence of&#xD;
               disease that may be serious and/or potentially affect results of the study.&#xD;
  &#xD;
            -  Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant&#xD;
               within the last 30 days prior the screening visit&#xD;
  &#xD;
            -  Recent (within ≤3 months prior the screening visit) history of heart attack, heart&#xD;
               failure, acute ischemic heart disease or presence of serious cardiac arrhythmia&#xD;
               requiring drug treatment.&#xD;
  &#xD;
            -  Regularly use of daytime CPAP (continuous positive airway pressure) oxygen therapy for&#xD;
               longer than 1 hour per day.&#xD;
  &#xD;
            -  Initiation of pulmonary rehabilitation within the 3 months prior the screening visit.&#xD;
  &#xD;
            -  History of lung volume reduction surgery&#xD;
  &#xD;
            -  Drug or alcohol abuse&#xD;
  &#xD;
            -  Presence of active tuberculosis&#xD;
  &#xD;
            -  History of atopy or allergic rhinitis&#xD;
  &#xD;
            -  Presence of active cancer&#xD;
  &#xD;
            -  Attenuated live virus vaccination within the last 2 weeks prior the screening visit or&#xD;
               during the run-in/wash-out period&#xD;
  &#xD;
            -  Pregnancy or lactation&#xD;
  &#xD;
            -  Presence of known symptomatic prostatic hypertrophy requiring treatment&#xD;
  &#xD;
            -  Presence of known narrow-angle glaucoma requiring treatment&#xD;
  &#xD;
            -  Currently participating in another clinical trial or treatment with another&#xD;
               investigational study drug within the last month or 6-half-lives, whichever is longer.&#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_contact>
      <last_name>Irem KARAMAN</last_name>
      <phone>05051747902</phone>
      <email>iremkaraman@neutecrdc.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Neutec RD</last_name>
      <email>meltembuyukzongur@neutecrdc.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Albuterol</mesh_term>
      <mesh_term>Ipratropium</mesh_term>
    </intervention_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/NCT06040424
  org study id: NEU-01.22
  nct id: NCT06040424
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the acute bronchodilator effect of pMDI formed
        Ipratropium / Levosalbutamol 20 mcg / 50 mcg fixed dose combination or pMDI formed Salbutamol
        100 mcg Inhaler and Ipratropium 20 mcg Inhalation Aerosol in combination in stable
        moderate-severe-very severe COPD patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, Parallel Group, Phase III, Non-inferiority Study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h)
  time frame: 8 hours
  description: Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
  measure: FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)
  time frame: 3 hours
  description: Change From Baseline in FEV1 AUC (0-3h).
  measure: FEV1 AUC 3-6 h
  time frame: 3 to 6 hours
  description: Change From Baseline in FEV1 AUC (3-6h).
  measure: FEV1 AUC 6-8 h
  time frame: 6 to 8 hours
  description: Change From Baseline in FEV1 AUC (6-8h).
  measure: FVC AUC 0-3 h
  time frame: 3 hours
  description: Change From Baseline in FVC AUC (0-3h).
  measure: FVC AUC 3-6 h
  time frame: 3 to 6 hours
  description: Change From Baseline in FVC AUC (3-6h).
  measure: FVC AUC 6-8 h
  time frame: 6 to 8 hours
  description: Change From Baseline in FVC AUC (6-8h).
  measure: FVC AUC 0-8 h
  time frame: 0 to 8 hours
  description: Change From Baseline in FVC AUC (0-8h).
  measure: Change From Baseline in FEV1 and FVC within the first 30 minutes after dosing (mL)
  time frame: Baseline, 30 minutes post-dose at treatment day
  description: Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
  measure: Mean Maximum Change From Baseline in FEV1 and FVC within the first 1 hours after dosing (mL)
  time frame: Baseline, 1 hours post-dose at treatment day
  description: Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
  measure: Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours (mL)
  time frame: Baseline, 0 to 8 hours post-dose at treatment day
  description: Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
  measure: The Time to Onset of Bronchodilator Response
  time frame: Baseline, 0 to 8 hours post-dose at treatment day
  description: Bronchodilator response is defined as 100 mL improvement in FEV1.
  measure: Evaluation of Safety
  time frame: Baseline, 0 to 24 hours post-dose
  description: Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs.
  arm group label: Ipratropium / Levosalbutamol Fixed Dose Combination
  arm group type: Experimental
  description: In this one-day study, patients will be administered 2 inhalation of "İPRALEV 20 mcg/50 mcg aerosol inhalasyonu, süspansiyon" at morning.
  arm group label: Ipratropium + Levosalbutamol Free Dose Combination
  arm group type: Active Comparator
  description: In this one-day study, patients will be administered 2 inhalations of "VENTOLİN İnhaler 100 mcg" and then 2 inhalations of "ATROVENT MDI 0,02 mg/dose" at morning.
  intervention type: Combination Product
  intervention name: Ipratropium / Levosalbutamol Fixed Dose Combination
  description: New combination test treatment
  arm group label: Ipratropium / Levosalbutamol Fixed Dose Combination
  intervention type: Drug
  intervention name: Ipratropium + Levosalbutamol Free Dose Combination
  description: Free combination control treatment
  arm group label: Ipratropium + Levosalbutamol Free Dose Combination
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Irem KARAMAN
  phone: 05051747902
  email: iremkaraman@neutecrdc.com
  last name: Neutec RD
  email: meltembuyukzongur@neutecrdc.com
  responsible party type: Sponsor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Albuterol
  mesh term: Ipratropium
  sharing ipd: No