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VX-770 for the Treatment of Chronic Bronchitis

Primary Purpose

Chronic Bronchitis

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ivacaftor (VX-770)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ivacaftor (VX770)

Arm Description

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

Outcomes

Primary Outcome Measures

change in lung function

Secondary Outcome Measures

Full Information

First Posted
August 14, 2017
Last Updated
February 1, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03251911
Brief Title
VX-770 for the Treatment of Chronic Bronchitis
Official Title
An Open Label Study to Investigate the Role of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis With CFTR Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivacaftor (VX770)
Arm Type
Experimental
Arm Description
Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
Intervention Type
Drug
Intervention Name(s)
Ivacaftor (VX-770)
Intervention Description
of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
Primary Outcome Measure Information:
Title
change in lung function
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VX-770 for the Treatment of Chronic Bronchitis

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