VX-770 for the Treatment of Chronic Bronchitis

  • STATUS
    Recruiting
  • End date
    Feb 1, 2022
  • participants needed
    1
  • sponsor
    University of Alabama at Birmingham
Updated on 10 July 2021
diabetes
pulmonary disease
cardiac arrhythmia
bronchodilator
vx-770
sweat chloride

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.

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.

Details
Condition Chronic bronchitis
Treatment Ivacaftor (VX-770)
Clinical Study IdentifierNCT03251911
SponsorUniversity of Alabama at Birmingham
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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