A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

Chronic Cough Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622216
• Other study ID #: ATA101-PN-001
• Status: Completed
• Phase: Phase 2
• Start date: November 5, 2018
• Est. completion date: May 22, 2019

Study information

• Verified date: June 2019
• Source: Attenua, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 22, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• Bradanicline
Three different doses over the course of the study
• Placebo
Matching placebo for Bradanicline

Locations

Country	Name	City	State
United States	Bellingham Asthma Allergy and Immunology Clinic	Bellingham	Washington
United States	Asthma and Allergy Associates	Colorado Springs	Colorado
United States	Storms Clinical Research Institute	Colorado Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Pharmaceutical Research and Consulting, Inc.	Dallas	Texas
United States	Colorado Allergy and Asthma Center	Denver	Colorado
United States	Clinical Research of Gastonia	Gastonia	North Carolina
United States	Allery Asthma & Sinus Center	Greenfield	Wisconsin
United States	BioSolutions Clinical Research Center	La Mesa	California
United States	Center for Cough	Largo	Florida
United States	Allergy & Asthma Associates of Southern California	Mission Viejo	California
United States	National Allergy and Asthma Research	North Charleston	South Carolina
United States	Atlantic Research Center, LLC	Ocean Township	New Jersey
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Mayo Clinic, Pulmonary Clinic Research Unit	Rochester	Minnesota
United States	Diagnostics Research Group	San Antonio	Texas
United States	Florida Pulmonary Research Institute	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Attenua, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Awake coughs per hour 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	Change from Baseline at Days 7, 14, 21, 43, 50, 57
Secondary	24-hour coughs per hour 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	Change from Baseline at Days 7, 14, 21, 43, 50, 57
Secondary	Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up	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)	up to 57 days