<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/NCT02260011</url>
  </required_header>
  <id_info>
    <org_study_id>244.2498</org_study_id>
    <nct_id>NCT02260011</nct_id>
  </id_info>
  <brief_title>Study of the Comparability of Ipratropium Bromide Hydrofluoroalkane (HFA)-134a Inhalation Aerosol to the Market Standard, Atrovent® Chlorofluorocarbon (CFC) Inhalation Aerosol, in Patients With Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>A Single-Dose, Double Blind, Crossover Trial to Determinate the Comparability of Ipratropium Bromide HFA-134a Inhalation Aerosol to the Market Standard, 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 compare the bronchodilator efficacy and safety of&#xD;
      ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation&#xD;
      Aerosol in COPD patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2000</start_date>
  <primary_completion_date type="Actual">February 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>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)</measure>
    <time_frame>After each drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in peak FEV1 response</measure>
    <time_frame>Baseline and after each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset of therapeutic FEV1 response</measure>
    <time_frame>After each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of therapeutic FEV1 response</measure>
    <time_frame>After each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak FEV1 response</measure>
    <time_frame>After each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Vital Capacity (FVC) AUC0-6</measure>
    <time_frame>After each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in FEV1</measure>
    <time_frame>Baseline and after each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 5 month after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak FVC response</measure>
    <time_frame>After each drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in FVC</measure>
    <time_frame>Baseline and after each drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Ipratropium bromide HFA-134a low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Ipratropium bromide HFA-134a high</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Atrovent® CFC low</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Atrovent® CFC high</arm_group_label>
    <arm_group_type>Active Comparator</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>Ipratropium bromide HFA-134a inhalation aerosol</intervention_name>
    <arm_group_label>Ipratropium bromide HFA-134a high</arm_group_label>
    <arm_group_label>Ipratropium bromide HFA-134a low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atrovent® CFC inhalation aerosol</intervention_name>
    <arm_group_label>Atrovent® CFC high</arm_group_label>
    <arm_group_label>Atrovent® CFC low</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</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 stable, moderate to severe airway obstruction with an FEV 1 (forced&#xD;
             expiratory volume in the first second) &lt;=65% of predicted normal and FEV1 &lt;=70% of FVC&#xD;
             (Forced Vital Capacity)&#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 patients 40 years of age or older&#xD;
&#xD;
          -  Patients must have a smoking history of more than ten pack-years&#xD;
&#xD;
          -  Patients must be able to demonstrate an improvement in FEV1 &gt;=015% within one hour&#xD;
             after inhalation of two puffs of Atrovent® inhalation aerosol (21 mcg per puff)&#xD;
&#xD;
          -  Patients must be able to satisfactorily administer the medication, perform pulmonary&#xD;
             function test and maintain records during the study period as required in the 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 disease other than COPD were 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 which may&#xD;
             influence the results of the study or the patient's ability to participate in the&#xD;
             study&#xD;
&#xD;
          -  Patients with clinical relevant baseline hematology, blood chemistry or urinalysis. If&#xD;
             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 not to be conducted in these patients&#xD;
&#xD;
          -  Patients with a history of asthma, allergic rhinitis or atopy or have a blood&#xD;
             eosinophil count above 600/mm³. A repeat eosinophil count will not to be conducted in&#xD;
             these patients&#xD;
&#xD;
          -  Patients with a recent history (i.e., one year or less) of myocardial infarction&#xD;
&#xD;
          -  Patients with a recent history (i.e., three years or less) of heart failure, patients&#xD;
             with any cardiac arrhythmia requiring therapy, patients receiving any systemic beta&#xD;
             blocker 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 five years. Patients with treated&#xD;
             basal 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 or a thoracotomy for other reasons be evaluated as per exclusion criterion No.&#xD;
             1&#xD;
&#xD;
          -  Patients with an upper respiratory tract infection or COPD exacerbation in the six&#xD;
             weeks prior to screening visit (vist1) 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 or women of childbearing potential not using a medically&#xD;
             approved means of contraception (e.g., oral contraceptives, intrauterine devices,&#xD;
             diaphragm or Norplant®)&#xD;
&#xD;
          -  Patients who have taken an investigational drug within one month or 6 half-lives&#xD;
             (whichever is longer) of the drug prior to the screening visit or patients currently&#xD;
             enrolled in other research study&#xD;
&#xD;
          -  Patients with a history of and/or active alcohol or drug abuse&#xD;
&#xD;
        Exclusion criteria for patients with allergies&#xD;
&#xD;
          -  Patients with active infectious rhinitis (common cold) as determined by history and&#xD;
             physical&#xD;
&#xD;
          -  Patients with upper or lower respiratory infection at screening&#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>October 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 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/NCT02260011
org study id: 244.2498
nct id: NCT02260011
lead sponsor: 
The objective of this study was to compare the bronchodilator efficacy and safety of
      ipratropium bromide HFA-134a inhalation aerosol and marketed, Atrovent® CFC Inhalation
      Aerosol in COPD patients
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double
measure: Forced expiratory volume in 1 second (FEV1) response, calculated as area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 (AUC0-6)
time frame: After each drug administration
measure: Changes in peak FEV1 response
time frame: Baseline and after each drug administration
measure: Onset of therapeutic FEV1 response
time frame: After each drug administration
measure: Duration of therapeutic FEV1 response
time frame: After each drug administration
measure: Time to peak FEV1 response
time frame: After each drug administration
measure: Forced Vital Capacity (FVC) AUC0-6
time frame: After each drug administration
measure: Changes from baseline in FEV1
time frame: Baseline and after each drug administration
measure: Number of patients with adverse events
time frame: Up to 5 month after first drug administration
measure: Peak FVC response
time frame: After each drug administration
measure: Changes from baseline in FVC
time frame: Baseline and after each drug administration
arm group label: Ipratropium bromide HFA-134a low
arm group type: Experimental
arm group label: Ipratropium bromide HFA-134a high
arm group type: Experimental
arm group label: Atrovent® CFC low
arm group type: Active Comparator
arm group label: Atrovent® CFC high
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Ipratropium bromide HFA-134a inhalation aerosol
arm group label: Ipratropium bromide HFA-134a high
arm group label: Ipratropium bromide HFA-134a low
intervention type: Drug
intervention name: Atrovent® CFC inhalation aerosol
arm group label: Atrovent® CFC high
arm group label: Atrovent® CFC low
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
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