A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
- Registration Number
- NCT03622216
- Lead Sponsor
- Attenua, Inc.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Bradanicline QD Placebo Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD Placebo Placebo Randomized crossover design of matching placebo tablets to be administered orally QD Bradanicline QD Bradanicline Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD Placebo Bradanicline Randomized crossover design of matching placebo tablets to be administered orally QD
- Primary Outcome Measures
Name Time Method Awake coughs per hour at Days 7, 14, 21, 43, 50, 57 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 Outcome Measures
Name Time Method 24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57 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
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up 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)
Trial Locations
- Locations (17)
BioSolutions Clinical Research Center
🇺🇸La Mesa, California, United States
Colorado Allergy and Asthma Center
🇺🇸Denver, Colorado, United States
Allergy & Asthma Associates of Southern California
🇺🇸Mission Viejo, California, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Atlantic Research Center, LLC
🇺🇸Ocean Township, New Jersey, United States
Pharmaceutical Research and Consulting, Inc.
🇺🇸Dallas, Texas, United States
Allery Asthma & Sinus Center
🇺🇸Greenfield, Wisconsin, United States
Asthma and Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
Center for Cough
🇺🇸Largo, Florida, United States
National Allergy and Asthma Research
🇺🇸North Charleston, South Carolina, United States
Storms Clinical Research Institute
🇺🇸Colorado Springs, Colorado, United States
Bellingham Asthma Allergy and Immunology Clinic
🇺🇸Bellingham, Washington, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Mayo Clinic, Pulmonary Clinic Research Unit
🇺🇸Rochester, Minnesota, United States
Florida Pulmonary Research Institute
🇺🇸Winter Park, Florida, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States