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

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

Study Overview

• Status: Completed
• Conditions: Chronic Cough
• Intervention / Treatment: Drug: Bradanicline; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Mesa, California, United States, 91942
      • Biosolutions Clinical Research Center
    • Mission Viejo, California, United States, 92691
      • Allergy & Asthma Associates of Southern California
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Storms Clinical Research Institute
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Center
  • Florida
    • Largo, Florida, United States, 33872
      • Center for Cough
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic, Pulmonary Clinic Research Unit
  • New Jersey
    • Ocean Township, New Jersey, United States, 07712
      • Atlantic Research Center, LLC
  • North Carolina
    • Gastonia, North Carolina, United States, 20854
      • Clinical Research of Gastonia
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy and Asthma Research
  • Texas
    • Dallas, Texas, United States, 75231
      • AARA Research Center
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research and Consulting, Inc.
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
  • Washington
    • Bellingham, Washington, United States, 98225
      • Bellingham Asthma Allergy and Immunology Clinic
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allery Asthma & Sinus Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bradanicline QD; Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD	Drug: Bradanicline; Three different doses over the course of the study; Drug: Placebo; Matching placebo for Bradanicline
PLACEBO_COMPARATOR: Placebo; Randomized crossover design of matching placebo tablets to be administered orally QD	Drug: Bradanicline; Three different doses over the course of the study; Drug: Placebo; Matching placebo for Bradanicline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Attenua, Inc.
• Investigators: Study Director: Medical Director, Attenua, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 5, 2018
• Primary Completion (ACTUAL): May 7, 2019
• Study Completion (ACTUAL): May 22, 2019

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 20, 2019
• Last Update Submitted That Met QC Criteria: June 18, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: ATA101-PN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No