<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/NCT04446637</url>
  </required_header>
  <id_info>
    <org_study_id>NEU-01.19</org_study_id>
    <nct_id>NCT04446637</nct_id>
  </id_info>
  <brief_title>Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD</brief_title>
  <official_title>Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe 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 purpose of this study is to compare acute bronchodilator effects of&#xD;
      Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and&#xD;
      Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2&#xD;
      inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    administrative decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 3, 2021</start_date>
  <completion_date type="Anticipated">September 3, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 3, 2022</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>Multicenter, single day, noninferiority study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FEV1 AUC (0-8h)</measure>
    <time_frame>Baseline, 0 to 8 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.&#xD;
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>FEV1 AUC (0-4h)</measure>
    <time_frame>Baseline, 0 to 4 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FEV1 AUC (0-4h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1 AUC (4-6h)</measure>
    <time_frame>Baseline, 4 to 6 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FEV1 AUC (4-6h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1 AUC (6-8h)</measure>
    <time_frame>Baseline, 6 to 8 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FEV1 AUC (6-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC AUC (0-4h)</measure>
    <time_frame>Baseline, 0 to 4 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC AUC (4-6h)</measure>
    <time_frame>Baseline, 4 to 6 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FVC AUC (4-6h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC AUC (6-8h)</measure>
    <time_frame>Baseline, 6 to 8 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FVC AUC (6-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC AUC (0-8h)</measure>
    <time_frame>Baseline, 0 to 8 hours post-dose at treatment day</time_frame>
    <description>Change From Baseline in FVC AUC (0-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing</measure>
    <time_frame>Baseline, 0 to 15 minutes post-dose at treatment day</time_frame>
    <description>Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing</measure>
    <time_frame>Baseline, 0 to 2 hours post-dose at treatment day</time_frame>
    <description>Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours</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, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</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. Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Time to Maximum Effect</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, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration 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. Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)</measure>
    <time_frame>Baseline, 0 to 24 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Ipratropium/Levosalbutamol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI</intervention_name>
    <description>Ipratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)</description>
    <arm_group_label>Ipratropium/Levosalbutamol</arm_group_label>
    <other_name>IPRALEV 20 mcg/50 mcg Aerosol Inhalation, Suspension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI</intervention_name>
    <description>Salbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).</description>
    <arm_group_label>Salbutamol + Ipratropium</arm_group_label>
    <other_name>VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female and male patients aged ≥40 years diagnosed with symptomathic stable&#xD;
             moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC &lt;70% predicted and a&#xD;
             post-bronchodilator FEV1 &lt;80% predicted at screen visit.&#xD;
&#xD;
        Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)&#xD;
&#xD;
        Group C COPD CAT: &lt;10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or&#xD;
        ≥1 (leading to hospital admission)&#xD;
&#xD;
        Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or&#xD;
        ≥1 (leading to hospital admission)&#xD;
&#xD;
          -  Current or ex-smokers with a smoking history of at least 10 pack-years&#xD;
&#xD;
          -  Patients who have no exacerbation within the last 4 weeks&#xD;
&#xD;
          -  Female patients who use effective contraception&#xD;
&#xD;
          -  Patients who have a capability to communicate with 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 hypersensitive to anticholinergics or SABAs&#xD;
&#xD;
          -  History of COPD exacerbation or lower respiratory track infection that required&#xD;
             treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks&#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;
          -  Use of oral corticosteroid at unstable dosages (i.e. &lt;6 weeks on a stable dose of&#xD;
             prednisone)&#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;
          -  Initiation of an inhaled steroid or change in dose within &lt;6 weeks prior the screening&#xD;
             visit&#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 ≤1 year 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 measure) 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;
          -  History of cancer within the last 5 years&#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>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismail Hanta, Professor Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cukurova University Faculty of Medicine, Chest Diseases Department Adana - Turkey</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hakan Gunen, Professor Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Maltepe, Istanbul - Turkey</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, MDI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <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>


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/NCT04446637
org study id: NEU-01.19
nct id: NCT04446637
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare acute bronchodilator effects of
      Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and
      Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2
      inhalations) Free Combination in Patients with stable moderate-severe-very severe COPD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, single day, noninferiority study
primary purpose: Treatment
masking: None (Open Label)
measure: FEV1 AUC (0-8h)
time frame: Baseline, 0 to 8 hours post-dose at treatment day
description: Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FEV1 AUC (0-4h)
time frame: Baseline, 0 to 4 hours post-dose at treatment day
description: Change From Baseline in FEV1 AUC (0-4h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FEV1 AUC (4-6h)
time frame: Baseline, 4 to 6 hours post-dose at treatment day
description: Change From Baseline in FEV1 AUC (4-6h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FEV1 AUC (6-8h)
time frame: Baseline, 6 to 8 hours post-dose at treatment day
description: Change From Baseline in FEV1 AUC (6-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FVC AUC (0-4h)
time frame: Baseline, 0 to 4 hours post-dose at treatment day
description: Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FVC AUC (4-6h)
time frame: Baseline, 4 to 6 hours post-dose at treatment day
description: Change From Baseline in FVC AUC (4-6h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FVC AUC (6-8h)
time frame: Baseline, 6 to 8 hours post-dose at treatment day
description: Change From Baseline in FVC AUC (6-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: FVC AUC (0-8h)
time frame: Baseline, 0 to 8 hours post-dose at treatment day
description: Change From Baseline in FVC AUC (0-8h). Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
time frame: Baseline, 0 to 15 minutes post-dose at treatment day
description: Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
time frame: Baseline, 0 to 2 hours post-dose at treatment day
description: Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
time frame: Baseline, 0 to 8 hours post-dose at treatment day
description: Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
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. Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: The Time to Maximum Effect
time frame: Baseline, 0 to 8 hours post-dose at treatment day
description: Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: Duration 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. Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
measure: Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)
time frame: Baseline, 0 to 24 hours post-dose
arm group label: Ipratropium/Levosalbutamol
arm group type: Experimental
description: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI
arm group label: Salbutamol + Ipratropium
arm group type: Active Comparator
description: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI
intervention type: Drug
intervention name: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI
description: Ipratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)
arm group label: Ipratropium/Levosalbutamol
other name: IPRALEV 20 mcg/50 mcg Aerosol Inhalation, Suspension
intervention type: Drug
intervention name: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI
description: Salbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).
arm group label: Salbutamol + Ipratropium
other name: VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/dose
criteria: 
gender: All
minimum age: 40 Years
maximum age: 120 Years
healthy volunteers: No
last name: Ismail Hanta, Professor Doctor
role: Principal Investigator
affiliation: Cukurova University Faculty of Medicine, Chest Diseases Department Adana - Turkey
last name: Hakan Gunen, Professor Doctor
role: Principal Investigator
affiliation: Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Maltepe, Istanbul - Turkey
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Albuterol
mesh term: Ipratropium
sharing ipd: No