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VX-770 for the Treatment of Chronic Bronchitis

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ClinicalTrials.gov Identifier: NCT03251911
Recruitment Status : Not yet recruiting
First Posted : August 16, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
George Solomon, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Drug: Ivacaftor (VX-770) Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study to Investigate the Role of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis With CFTR Dysfunction
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ivacaftor

Arm Intervention/treatment
Experimental: Ivacaftor (VX770)
Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
Drug: Ivacaftor (VX-770)
of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction




Primary Outcome Measures :
  1. change in lung function [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female age 18 years
  • A Clinical diagnosis of Bronchiectasis and/or Chronic Bronchitis in the investigators opinion
  • Exhibit symptoms of chronic bronchitis as defined by the Medical Research Council
  • FEV1 percent predicted greater than 40 percent Post Bronchodilator
  • Clinically stable in the last 4 weeks with no evidence of exacerbation
  • Weight of 40 kg to120 kg
  • Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
  • Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy
  • Element of CFTR Dysfunction, as defined by Sweat Chloride

Exclusion

  • Daytime use of Oxygen Therapy
  • Documented history of drug abuse within the last year
  • Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
  • Cirrhosis or elevated liver transaminases > 3X ULN
  • GFR < 50 estimated by Cockroft-Gault
  • Any illness or abnormal lab finding that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
  • Pregnant or Breastfeeding
  • Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit juice. (Excluded medications and foods including the drugs and foods are provided in the appendix document)
  • Uncontrolled Diabetes
  • Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator that affect patient safety

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251911


Locations
United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Heather Hathorne, PhD    205-638-9568    hhathorne@peds.uab.edu   
Contact: Ginger Reeves, BS    205-638-5970    greeves@peds.uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

Responsible Party: George Solomon, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03251911     History of Changes
Other Study ID Numbers: F160914011
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchitis, Chronic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Ivacaftor
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action