<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/NCT02236169</url>
  </required_header>
  <id_info>
    <org_study_id>244.2480</org_study_id>
    <nct_id>NCT02236169</nct_id>
  </id_info>
  <brief_title>Trial to Determine the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to ATROVENT® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>An Open-Label, Crossover, Pharmacokinetic Trial to Determine the Comparability of 84 µg Ipratropium Bromide HFA-134a Inhalation Aerosol to 84 µg ATROVENT® CFC Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The objective of this study was to determine the pharmacokinetic comparability of 84 µg&#xD;
      ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in&#xD;
      COPD patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2000</start_date>
  <primary_completion_date type="Actual">April 2001</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose</measure>
    <time_frame>Up to 24 hours (h) after single drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state</measure>
    <time_frame>1h after drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state</measure>
    <time_frame>up to 6 h after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma ipratropium concentration time curve at different time points</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma ipratropium concentration at different time points</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough plasma ipratropium concentration at different time points</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak plasma ipratropium concentrations at steady state</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of fluctuation (DF) of the plasma ipratropium concentrations</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma ipratropium concentration time curve</measure>
    <time_frame>Day 1 after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma ipratropium concentration</measure>
    <time_frame>Day 1 after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in pulse rate and blood pressure</measure>
    <time_frame>Baseline, day 23 day after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in laboratory tests</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in physical examination</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical significant findings in electrocardiogram (ECG)</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from test-day baseline in pulse rate and blood pressure</measure>
    <time_frame>Up to 23 days after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Ipratropium bromide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ATROVENT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipratropium bromide HFA-134a inhalation aerosol</intervention_name>
    <arm_group_label>Ipratropium bromide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atrovent CFC inhalation aerosol</intervention_name>
    <arm_group_label>ATROVENT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients must have a diagnosis of COPD and must meet the following spirometric&#xD;
        criteria:&#xD;
&#xD;
          -  Patients must have a stable, moderate to severe airway obstruction with an Forced&#xD;
             Expiratory Volume in one second (FEV1) &lt;=65% of predicted normal and FEV1 &lt;=70% of&#xD;
             Forced vital capacity (FVC)&#xD;
&#xD;
               -  Males: Predicted Normal FEV1 = 0.093 (height in inches)-0.032 (age)-1.343&#xD;
&#xD;
               -  Females: Predicted Normal FEV1 = 0.085 (height in inches)-0.025(age)-1.692&#xD;
&#xD;
          -  Male or female age 40 years or older&#xD;
&#xD;
          -  Patients must have a smoking history of more than 10 pack-years. A pack-year is&#xD;
             defined as the equivalent of smoking one pack of cigarettes (20 cigarettes) per day&#xD;
             for a year&#xD;
&#xD;
          -  Patients must be able to satisfactorily administer the medication, perform pulmonary&#xD;
             function tests (PFTs) and maintain records during the study period as required in the&#xD;
             protocol&#xD;
&#xD;
          -  All patients must sign an Informed Consent Form prior to participation in the trial&#xD;
             (i.e., prior to pre-study washout of their usual pulmonary medications and prior to&#xD;
             fasting for laboratory tests)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with significant diseases other than COPD will be excluded. A significant&#xD;
             disease is defined as a disease which in the opinion of the investigator may either&#xD;
             put the patient at risk because of participation in the study or a disease with may&#xD;
             influence the results of the study or patients ability to participate in the study&#xD;
&#xD;
          -  Patients with clinically relevant baseline hematology, blood chemistry or urinalysis.&#xD;
             If the abnormality defines a disease listed as an exclusion criterion the patient is&#xD;
             excluded&#xD;
&#xD;
          -  All patients with serum glutamic oxaloacetic transaminase (SGOT) &gt;80 IU/L, serum&#xD;
             glutamic pyruvic transaminase (SGPT) &gt;80 IU/L, bilirubin &gt;2.0 mg/dl, or creatinine&#xD;
             &gt;2.0 mg/dl will be excluded regardless of the clinical condition. Repeat laboratory&#xD;
             evaluation will be not be conducted in these patients&#xD;
&#xD;
          -  Patients with a history of asthma, allergic rhinitis or atopy or who have a blood&#xD;
             eosinophil count above 600/mm3. A repeat eosinophil count will be not be conducted in&#xD;
             these patients&#xD;
&#xD;
          -  Patients with a recent (i.e., one year or less) history of myocardial infarction&#xD;
&#xD;
          -  Patients with a recent history (i.e., three years or less) of cardiac failure,&#xD;
             patients with cardiac arrhythmia requiring therapy, patients receiving any systemic&#xD;
             beta-blockers and patients on chronic daytime oxygen therapy&#xD;
&#xD;
          -  Patients with known active tuberculosis&#xD;
&#xD;
          -  Patients with a history of cancer within the last 5 years. Patients with treated basal&#xD;
             cell carcinoma are allowed&#xD;
&#xD;
          -  Patients with a history of life-threatening pulmonary obstruction, or a history of&#xD;
             cystic fibrosis or bronchiectasis&#xD;
&#xD;
          -  Patients who have undergone thoracotomy with pulmonary resection. Patients with a&#xD;
             history of thoracotomy for other reason should be evaluated per exclusion criterion&#xD;
             No.1&#xD;
&#xD;
          -  Patients with an upper respiratory tract infection or COPD exacerbation in the 6 weeks&#xD;
             prior to the screening visit (Visit 1) or during the baseline period&#xD;
&#xD;
          -  Patients with known hypersensitivity to anticholinergic drugs&#xD;
&#xD;
          -  Patients with known symptomatic prostatic hypertrophy or bladder-neck obstruction&#xD;
&#xD;
          -  Patients with known narrow-angle glaucoma&#xD;
&#xD;
          -  Patients who are on cromolyn sodium or nedocromil sodium&#xD;
&#xD;
          -  Patients who are on antihistamines&#xD;
&#xD;
          -  Pregnant or nursing women and women of childbearing potential not using a medically&#xD;
             approved means of contraception (e.g., oral contraceptive, intrauterine devices,&#xD;
             diaphragm or Norplant®)&#xD;
&#xD;
          -  Patients who have taken an investigational drug within 1 month or 6 half-lives&#xD;
             (whichever is longer) of the drug prior to the screening visit or patients currently&#xD;
             enrolled in another research study&#xD;
&#xD;
          -  Patients with a history of and/or active alcohol or drug abuse&#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>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</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</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Norflurane</mesh_term>
    <mesh_term>Ipratropium</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02236169
org study id: 244.2480
nct id: NCT02236169
lead sponsor: 
The objective of this study was to determine the pharmacokinetic comparability of 84 µg
      ipratropium bromide HFA-134a inhalation aerosol and 84 µg ATROVENT® CFC Inhalation Aerosol in
      COPD patients
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Amount of unchanged ipratropium excreted in the urine from 0 to 24 h after a single dose
time frame: Up to 24 hours (h) after single drug administration
measure: Amount of unchanged ipratropium excreted in the urine within 1 hour at steady state
time frame: 1h after drug administration
measure: Amount of unchanged ipratropium excreted in the urine over the 6 h dosing interval at steady state
time frame: up to 6 h after drug administration
measure: Area under the plasma ipratropium concentration time curve at different time points
time frame: Up to 23 days after first drug administration
measure: Peak plasma ipratropium concentration at different time points
time frame: Up to 23 days after first drug administration
measure: Trough plasma ipratropium concentration at different time points
time frame: Up to 23 days after first drug administration
measure: Time to peak plasma ipratropium concentrations at steady state
time frame: Up to 23 days after first drug administration
measure: Degree of fluctuation (DF) of the plasma ipratropium concentrations
time frame: Up to 23 days after first drug administration
measure: Area under the plasma ipratropium concentration time curve
time frame: Day 1 after first drug administration
measure: Peak plasma ipratropium concentration
time frame: Day 1 after first drug administration
measure: Number of patients with adverse events
time frame: Up to 23 days after first drug administration
measure: Changes from baseline in pulse rate and blood pressure
time frame: Baseline, day 23 day after first drug administration
measure: Number of patients with clinical significant findings in laboratory tests
time frame: Up to 23 days after first drug administration
measure: Number of patients with clinical significant findings in physical examination
time frame: Up to 23 days after first drug administration
measure: Number of patients with clinical significant findings in electrocardiogram (ECG)
time frame: Up to 23 days after first drug administration
measure: Changes from test-day baseline in pulse rate and blood pressure
time frame: Up to 23 days after first drug administration
arm group label: Ipratropium bromide
arm group type: Experimental
arm group label: ATROVENT
arm group type: Active Comparator
intervention type: Drug
intervention name: Ipratropium bromide HFA-134a inhalation aerosol
arm group label: Ipratropium bromide
intervention type: Drug
intervention name: Atrovent CFC inhalation aerosol
arm group label: ATROVENT
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Respiratory Aspiration
mesh term: Bromides
mesh term: Norflurane
mesh term: Ipratropium