VX-770 for the Treatment of Chronic Bronchitis

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03251911

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Jan 1, 2020

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Feb 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change in lung function [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

George Solomon, Principal Investigator, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT03251911

Other Study ID Numbers:

F160914011

First Posted:

Aug 16, 2017

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2022