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
1 other identifier
interventional
46
1 country
17
Brief Summary
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2018
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedStudy Start
First participant enrolled
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 22, 2019
CompletedJune 20, 2019
June 1, 2019
6 months
August 2, 2018
June 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
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
up to 57 days
Study Arms (2)
Bradanicline QD
EXPERIMENTALRandomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
Placebo
PLACEBO COMPARATORRandomized crossover design of matching placebo tablets to be administered orally QD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Attenua, Inc.lead
Study Sites (17)
BioSolutions Clinical Research Center
La Mesa, California, 91942, United States
Allergy & Asthma Associates of Southern California
Mission Viejo, California, 92691, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, 80907, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Center
Denver, Colorado, 80230, United States
Center for Cough
Largo, Florida, 33872, United States
Florida Pulmonary Research Institute
Winter Park, Florida, 32789, United States
Clinical Research Institute
Plymouth, Minnesota, 55441, United States
Mayo Clinic, Pulmonary Clinic Research Unit
Rochester, Minnesota, 55905, United States
Atlantic Research Center, LLC
Ocean Township, New Jersey, 07712, United States
Clinical Research of Gastonia
Gastonia, North Carolina, 20854, United States
National Allergy and Asthma Research
North Charleston, South Carolina, 29420, United States
AARA Research Center
Dallas, Texas, 75231, United States
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Bellingham Asthma Allergy and Immunology Clinic
Bellingham, Washington, 98225, United States
Allery Asthma & Sinus Center
Greenfield, Wisconsin, 53228, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Attenua, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2018
First Posted
August 9, 2018
Study Start
November 5, 2018
Primary Completion
May 7, 2019
Study Completion
May 22, 2019
Last Updated
June 20, 2019
Record last verified: 2019-06