VX-770 for the Treatment of Chronic Bronchitis

NCT03251911 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: F160914011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Bronchitis

Outcome Measures

Primary Outcomes (1)

• change in lung function

  1 year

Study Arms (1)

Ivacaftor (VX770)

EXPERIMENTAL

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

Drug: Ivacaftor (VX-770)

Interventions

Ivacaftor (VX-770) DRUG

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

Ivacaftor (VX770)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

ivacaftor

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: January 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)