Chronic Cough
Conditions
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.
Interventions
DRUGBradanicline
Three different doses over the course of the study
DRUGPlacebo
Matching placebo for Bradanicline
Sponsors
Attenua, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed