Chronic Cough
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.
Interventions
DRUGAX-8, Part 1 of the study
orally disintegrating tablets, BID
DRUGPlacebo, Part 1 of the study
orally disintegrating tablets, BID
DRUGAX-8, Part 2 of the study
orally disintegrating tablets, TID
DRUGPlacebo, Part 2 of the study
orally disintegrating tablets, TID
Sponsors
Axalbion SA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough * Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC) for at least one year * Women of childbearing potential and their male partners must use 2 acceptable methods of contraception * Male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception * Have provided written informed consent
Exclusion criteria
* Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) * Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years * Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit * History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks * History of cystic fibrosis * Positive test for any drug of abuse * History of malignancy within 5 years prior to the Baseline Visit * History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) * History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 of the study: Change from Baseline in objective cough frequency in the 8 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period | Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period | Assessment of number of coughs per hour to be evaluated using a digital recording device |
| Part 2 of the study: Change from Baseline in objective cough frequency in the 4 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period | Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period | Assessment of number of coughs per hour to be evaluated using a digital recording device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in awake cough frequency | Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period | 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 in Cough Severity Visual Analog Scale (VAS) score | Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period | Cough Severity is determined through the use of a 100 mm visual analogue scale (VAS) (ranging between 0 for no cough and 100 for worst cough). |
| Incidence (percent of participants) of treatment-emergent adverse events (TEAEs) | From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included) | TEAEs are defined as those AEs (i.e., a new event or an exacerbation of a pre-existing condition) occurring on or after the first study dosing (i.e., Dose 1 on Day 1). |
| Incidence (percent of participants) of serious adverse events (SAEs) | From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included) | An SAE is an adverse events occurring during any study phase and that fulfils one or more of the following: results in death, is life-threatening, requires patient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a significant or important medical event, or is a congenital anomaly/birth defect in the offspring of a subject who received study drug. |
Countries
United Kingdom
Outcome results
None listed