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VX-770 for the Treatment of Chronic Bronchitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03251911
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : January 30, 2020
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.

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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
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 1, 2022

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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


  • 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 identifier (NCT number): NCT03251911

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Heather Hathorne, PhD    205-638-9568   
Contact: Ginger Reeves, BS    205-638-5970   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: George Solomon, Principal Investigator, University of Alabama at Birmingham Identifier: NCT03251911    
Other Study ID Numbers: F160914011
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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