Trial | NCT03622216  Report issue

Title

A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    46
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.
Study Started
Nov 05
2018
Primary Completion
May 07
2019
Study Completion
May 22
2019
Last Update
Jun 20
2019

Drug Bradanicline

Three different doses over the course of the study

Drug Placebo

Matching placebo for Bradanicline

Bradanicline QD Experimental

Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD

Placebo Placebo Comparator

Randomized crossover design of matching placebo tablets to be administered orally QD

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
No Results Posted