<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/NCT03251911</url>
  </required_header>
  <id_info>
    <org_study_id>F160914011</org_study_id>
    <nct_id>NCT03251911</nct_id>
  </id_info>
  <brief_title>VX-770 for the Treatment of Chronic Bronchitis</brief_title>
  <official_title>An Open Label Study to Investigate the Role of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis With CFTR Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study will test how well a new drug affects bronchiectasis or chronic&#xD;
      bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by&#xD;
      the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic&#xD;
      Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic&#xD;
      bronchitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an open label study of orally-administered ivacaftor in subjects with chronic&#xD;
      bronchitis and/or bronchiectasis. Subjects will be administered the study drug ivacaftor 150&#xD;
      mg twice daily (BID). The study drug is commercially available and will be purchased by the&#xD;
      participant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no participants enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in lung function</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Bronchitis</condition>
  <arm_group>
    <arm_group_label>Ivacaftor (VX770)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivacaftor (VX-770)</intervention_name>
    <description>of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction</description>
    <arm_group_label>Ivacaftor (VX770)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female age 18 years&#xD;
&#xD;
          -  A Clinical diagnosis of Bronchiectasis and/or Chronic Bronchitis in the investigators&#xD;
             opinion&#xD;
&#xD;
          -  Exhibit symptoms of chronic bronchitis as defined by the Medical Research Council&#xD;
&#xD;
          -  FEV1 percent predicted greater than 40 percent Post Bronchodilator&#xD;
&#xD;
          -  Clinically stable in the last 4 weeks with no evidence of exacerbation&#xD;
&#xD;
          -  Weight of 40 kg to120 kg&#xD;
&#xD;
          -  Willingness to use at least one form of acceptable birth control including abstinence,&#xD;
             condom with spermicide, or hormonal contraceptives&#xD;
&#xD;
          -  Willing to monitor blood glucose if known history of diabetes mellitus requiring&#xD;
             insulin or medical therapy&#xD;
&#xD;
          -  Element of CFTR Dysfunction, as defined by Sweat Chloride&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Daytime use of Oxygen Therapy&#xD;
&#xD;
          -  Documented history of drug abuse within the last year&#xD;
&#xD;
          -  Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary&#xD;
             disease within 28 days before receiving the first dose of study drug.&#xD;
&#xD;
          -  Cirrhosis or elevated liver transaminases &gt; 3X ULN&#xD;
&#xD;
          -  GFR &lt; 50 estimated by Cockroft-Gault&#xD;
&#xD;
          -  Any illness or abnormal lab finding that, in the opinion of the investigator might&#xD;
             confound the results of the study or pose an additional risk in administering study&#xD;
             drug to the subject.&#xD;
&#xD;
          -  Pregnant or Breastfeeding&#xD;
&#xD;
          -  Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal&#xD;
             medications and grapefruit juice. (Excluded medications and foods including the drugs&#xD;
             and foods are provided in the appendix document)&#xD;
&#xD;
          -  Uncontrolled Diabetes&#xD;
&#xD;
          -  Clinically significant arrhythmias or conduction abnormalities that in the opinion of&#xD;
             the investigator that affect patient safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>George Solomon</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchitis</mesh_term>
    <mesh_term>Bronchitis, Chronic</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ivacaftor</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/NCT03251911
org study id: F160914011
nct id: NCT03251911
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This research study will test how well a new drug affects bronchiectasis or chronic
      bronchitis. The new drug, Ivacaftor (KALYDECO), is a drug that has recently been approved by
      the U.S. Food and Drug Administration (FDA) for patients with a lung disease called Cystic
      Fibrosis (CF). It has not been approved for use in patients with bronchiectasis or chronic
      bronchitis.
The study is an open label study of orally-administered ivacaftor in subjects with chronic
      bronchitis and/or bronchiectasis. Subjects will be administered the study drug ivacaftor 150
      mg twice daily (BID). The study drug is commercially available and will be purchased by the
      participant.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in lung function
time frame: 1 year
arm group label: Ivacaftor (VX770)
arm group type: Experimental
description: Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
intervention type: Drug
intervention name: Ivacaftor (VX-770)
description: of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
arm group label: Ivacaftor (VX770)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: George Solomon
investigator title: Principal Investigator
mesh term: Bronchitis
mesh term: Bronchitis, Chronic
mesh term: Acute Disease
mesh term: Ivacaftor
sharing ipd: No