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WithdrawnNCT03251911Updated Feb 17, 2022

VX-770 for the Treatment of Chronic Bronchitis

A Phase 4 interventional study of Ivacaftor (VX-770) in Chronic Bronchitis, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment

Why this study was withdrawn
no participants enrolled
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Ivacaftor (VX770)

    Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction

    Drug: Ivacaftor (VX-770)

Interventions

  • DrugIvacaftor (VX-770)

    of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction

05

What researchers measure

Primary outcomes

  1. change in lung function

    Time frame: 1 year

06

Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03251911
Lead sponsor
University of Alabama at Birmingham
Responsible party
George Solomon (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 16, 2017
Start date
Jan 1, 2020
Primary completion
Feb 1, 2022
Completion
Feb 1, 2022
Last update
Feb 17, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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