<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/NCT02249312</url>
  </required_header>
  <id_info>
    <org_study_id>543.11</org_study_id>
    <nct_id>NCT02249312</nct_id>
  </id_info>
  <brief_title>The Effect of BIIL 284 BS on Induced-sputum Variables in Patients With Bronchial Asthma</brief_title>
  <official_title>The Effect of BIIL 284 BS (14 Day Treatment) on Induced-sputum Variables in Patients With Bronchial Asthma (a Double-blind, Randomized, Placebo-controlled Parallel Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in&#xD;
      patients with asthma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1999</start_date>
  <primary_completion_date type="Actual">April 2000</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of neutrophils in induced sputum differential cell count</measure>
    <time_frame>Baseline, Day 1 and 14</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of myeloperoxidase (MPO) in induced sputum</measure>
    <time_frame>Baseline, Day 1 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Interleukin-8 (IL-8) in induced sputum</measure>
    <time_frame>Baseline, Day 1 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of tumor necrosis factor (TNF) alpha in induced sputum</measure>
    <time_frame>Baseline, Day 1 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differential cell count in induced sputum</measure>
    <time_frame>Baseline, Day 1 and 14</time_frame>
    <description>eosinophils, basophils, macrophages, lymphocytes and epithelia cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in expression of Epidermal growth Factor (EGF) receptors in induced sputum</measure>
    <time_frame>Day 1 and 14</time_frame>
    <description>only in US center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in expression of tissue growth factor (TGF) alpha in induced sputum</measure>
    <time_frame>Day 1 and 14</time_frame>
    <description>only in US center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in expression of MUC5AC (maximum use concentration) in induced sputum</measure>
    <time_frame>Day 1 and 14</time_frame>
    <description>only in US center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced vital capacity (FVC)</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in forced expiratory flow (FEF) 25-70%</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FEF50%</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FEF 75%</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
    <description>assessed by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in peak expiratory flow rate (PEFR) a.m. versus p.m.by patients daily records</measure>
    <time_frame>Up to Day 27 after drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physician's global evaluation of symptoms assessed on a 6 point severity scale</measure>
    <time_frame>Baseline, Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inhibition of MAC-1 expression</measure>
    <time_frame>Day 1 and 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Adverse Events</measure>
    <time_frame>Up to day 27 after drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>BIIIL</arm_group_label>
    <arm_group_type>Experimental</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>BIIL 284 BS</intervention_name>
    <arm_group_label>BIIIL</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;
          -  Written informed consent signed and dated prior to participation into the study&#xD;
&#xD;
          -  Males and females aged 18 - 65 years. Female patients of child bearing potential&#xD;
             cannot participate in this study. Female patients are eligible to participate only if&#xD;
             they are surgically sterilized or two years post menopausal. Women entering into this&#xD;
             trial will have a pregnancy test before and after participation in the trial. Testing&#xD;
             will be done during visit 1 and visit 5&#xD;
&#xD;
          -  A documented diagnosis of asthma as defined by the American thoracic society i.e.,&#xD;
             episodic wheezing, chest tightness, cough and/or shortness of breath at least&#xD;
             partially relieved by bronchodilator medication. No hospital admission in the last&#xD;
             eight weeks for the treatment of asthma; no requirement for steroid therapy (systemic&#xD;
             or inhaled) for the previous four weeks, nedocromil sodium or sodium cromoglycate in&#xD;
             the previous two weeks; asthma therapy stable and limited to intermittent use of&#xD;
             inhaled β2-agonists or anticholinergics on an as required basis, or occasional use of&#xD;
             antihistamines. Predicted equations for forced expiratory volume in one second (FEV1)&#xD;
             of Caucasians and African - Americans are those of Morris et. al. and Glindmeyer et.&#xD;
             al. At visit 2, 3, and 5, immediately prior to the induced sputum test, but following&#xD;
             albuterol administration, a patient's FEV1 must be above 60 % of predicted&#xD;
&#xD;
          -  The presence of, at least, 25 % of neutrophils in induced sputum during screening&#xD;
             visit 2 (this requirement refers to the neutrophils percentage exclusive of squamous&#xD;
             cells)&#xD;
&#xD;
          -  Ability to produce an adequate induced sputum sample (visit 2) as defined by: Volume &gt;&#xD;
             1 ml, squamous cells &lt; 80 % and ability to tolerate the procedure for at least 4&#xD;
             minutes with no bronchoconstriction (a fall in FEV1 &gt; 20 %)&#xD;
&#xD;
          -  Patients with PC20 methacholine &lt;= 8 mg/ml as determined at visit 1&#xD;
&#xD;
          -  Non-smokers (patients who have never smoked) or ex-smokers for at least one year with&#xD;
             a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per&#xD;
             day for 1 year)&#xD;
&#xD;
          -  Ability to be trained in the proper use of peak flow meter (Mini Wright peak flow&#xD;
             meter, Clement Clarke, Inc.) and in performing and recording technically satisfactory&#xD;
             pulmonary function tests&#xD;
&#xD;
          -  Willing to attend an outpatient clinic on a regular basis and undergo three induced&#xD;
             sputum challenges during which they will be confined to the investigational unit for&#xD;
             up to two hours&#xD;
&#xD;
          -  Ability to comply with the concomitant therapy restrictions&#xD;
&#xD;
          -  Patients will be off all prescription drug therapy other than that specifically for&#xD;
             asthma or hay fever. Over the counter (O.T.C.) drugs must be discontinued for at least&#xD;
             two weeks prior to participation in the study. If any O.T.C. medication is needed by&#xD;
             patients throughout the study, the investigator will call the clinical monitor and&#xD;
             this will be reviewed on a case-by-case basis&#xD;
&#xD;
          -  Patients will have no evidence of clinically relevant concomitant disease based upon&#xD;
             complete medical history, full physical examination, chest x-ray (if not done in&#xD;
             previous 6 months), electrocardiogram (ECG) and clinical laboratory tests. These tests&#xD;
             should indicate that the patient is healthy except for changes related to asthma or&#xD;
             atopy (e.g., eosinophilia based on a total eosinophil count). Patient may have a&#xD;
             history of allergic rhinitis or urticaria.&#xD;
&#xD;
               -  The following laboratory parameters must be within the normal range, or if not,&#xD;
                  be documented by the investigator as not clinically relevant:&#xD;
&#xD;
               -  Routine urinalysis, Complete blood cell (CBC) (excluding White blood cell (WBC))&#xD;
                  , Na, K, Ca, Cl, Gamma-glutamyl-transferase (GGT), Lactic dehydrogenase (LDH),&#xD;
                  bicarbonate, inorganic phosphorus, glucose, uric acid, triglyceride, total&#xD;
                  protein, albumin and cholesterol.&#xD;
&#xD;
               -  The following test may be outside the normal range to the extent indication:&#xD;
&#xD;
                    -  Test a; Liver function tests: serum glutamic oxaloacetic transaminase /&#xD;
                       aspartate aminotransferase (SGOT/AST), serum glutamic pyruvic transaminase /&#xD;
                       alanine transaminase (SGPT/ALT), total bilirubin (in patients with an&#xD;
                       isolated raised bilirubin and diagnosis of &quot; suspected Gilbert's syndrome&quot;&#xD;
                       will be accepted only after the effect of high carbohydrate meal or&#xD;
                       bilirubin level has been determined) and alkaline phosphatase with a cut off&#xD;
                       for exclusion by 10 % &gt; ULN (upper limit of normal range for the measuring&#xD;
                       laboratory)&#xD;
&#xD;
                    -  Test b; Hematology: WBC with a cut off for exclusion by &lt; 3.80 x 10**9 /L,&#xD;
                       neutrophils with a cut off for exclusion by &lt; 2.00 x 10**9 /L, platelets&#xD;
                       with a cut off for exclusion by &lt; 100 x 10**9 /L, hemoglobin with a cut off&#xD;
                       for exclusion by &lt; 12 g/dL&#xD;
&#xD;
                    -  Test c; urea nitrogen and creatinine with a cut off for exclusion by 10 % &gt;&#xD;
                       ULN&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Viral respiratory tract infection, respiratory tract infection or asthma exacerbation&#xD;
             within the six weeks preceding the study or, if hospitalized for their asthma in the&#xD;
             last eight weeks&#xD;
&#xD;
          -  Evidence of relevant concomitant disease based on complete medical history, full&#xD;
             physical examination and clinical laboratory tests&#xD;
&#xD;
          -  Known drug or alcohol dependence (absence of dependency for 10 years), history of&#xD;
             significant allergic reactions to drugs or sensitivity to aspirin&#xD;
&#xD;
          -  Use of an investigational new drug in the preceding month or six half lives (whichever&#xD;
             is greater) prior to the first screen at visit 1&#xD;
&#xD;
          -  Donate of blood during the preceding month of visit 1&#xD;
&#xD;
          -  Patients receiving hyposensitization therapy who are not on a stable dose for the last&#xD;
             three months before visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</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 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 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>Asthma</mesh_term>
  </condition_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/NCT02249312
org study id: 543.11
nct id: NCT02249312
lead sponsor: 
Study to evaluate the anti-inflammatory effect of BIIL 284 BS compared with placebo in
      patients with asthma
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Percentage of neutrophils in induced sputum differential cell count
time frame: Baseline, Day 1 and 14
measure: Concentration of myeloperoxidase (MPO) in induced sputum
time frame: Baseline, Day 1 and 14
measure: Concentration of Interleukin-8 (IL-8) in induced sputum
time frame: Baseline, Day 1 and 14
measure: Concentration of tumor necrosis factor (TNF) alpha in induced sputum
time frame: Baseline, Day 1 and 14
measure: Differential cell count in induced sputum
time frame: Baseline, Day 1 and 14
description: eosinophils, basophils, macrophages, lymphocytes and epithelia cells
measure: Changes in expression of Epidermal growth Factor (EGF) receptors in induced sputum
time frame: Day 1 and 14
description: only in US center
measure: Changes in expression of tissue growth factor (TGF) alpha in induced sputum
time frame: Day 1 and 14
description: only in US center
measure: Changes in expression of MUC5AC (maximum use concentration) in induced sputum
time frame: Day 1 and 14
description: only in US center
measure: Changes in forced expiratory volume in one second (FEV1)
time frame: Up to Day 27 after drug administration
description: assessed by spirometry
measure: Changes in forced vital capacity (FVC)
time frame: Up to Day 27 after drug administration
description: assessed by spirometry
measure: Changes in forced expiratory flow (FEF) 25-70%
time frame: Up to Day 27 after drug administration
description: assessed by spirometry
measure: Changes in FEF50%
time frame: Up to Day 27 after drug administration
description: assessed by spirometry
measure: Changes in FEF 75%
time frame: Up to Day 27 after drug administration
description: assessed by spirometry
measure: Changes in peak expiratory flow rate (PEFR) a.m. versus p.m.by patients daily records
time frame: Up to Day 27 after drug administration
measure: Physician's global evaluation of symptoms assessed on a 6 point severity scale
time frame: Baseline, Day 14
measure: Inhibition of MAC-1 expression
time frame: Day 1 and 14
measure: Number of patients with Adverse Events
time frame: Up to day 27 after drug administration
arm group label: BIIIL
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: BIIL 284 BS
arm group label: BIIIL
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Asthma