NCT03251911

VX-770 for the Treatment of Chronic Bronchitis

An Open Label Study to Investigate the Role of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis With CFTR Dysfunction

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Ivacaftor (VX-770)	of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2017-08-16
• Last updated: 2022-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study