A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

• Status: Completed
• Trial end date: 2019-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Attenua, Inc.

Criteria

Inclusion Criteria:

• Chest radiograph or computed tomography (CT) scan of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough

• Diagnosis of refractory chronic cough or unexplained cough for at least one year

• Women of child-bearing potential who use 2 forms of acceptable birth control method

• Male subjects and their partners of child-bearing potential who use 2 methods of acceptable birth control

• Has provided written informed consent

Exclusion Criteria:

• Current smoker (cigarettes or e-cigarettes) or has given up smoking within the past 12 months

• Currently taking an ACE-inhibitor or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit

• Has an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit

• Has a history of cystic fibrosis

• Has a history of malignancy within 5 years prior to the Baseline Visit

• Has active hepatitis infection

• Has a history of human immunodeficiency virus (HIV) infection

• Has a positive test for any drug of abuse

• Has a history of hypersensitivity to bradanicline or any of its components