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Completed

NCT Number: NCT03622216

A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

BioSolutions Clinical Research Center, La Mesa, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bradanicline

Drug

Three different doses over the course of the study

Placebo

Drug

Matching placebo for Bradanicline

Primary outcomes

  1. Awake coughs per hour at Days 7, 14, 21, 43, 50, 57

    Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57

    Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device

Secondary outcomes

  1. 24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57

    Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57

    Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device

  2. Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up

    Time frame: up to 57 days

    Assessment of participants who have at least one AE during treatment period 1 (21 days), during washout (14 days), during treatment period 2 (21 days), and follow-up (14 days)

Sponsors and collaborators

Lead sponsor

Attenua, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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