A Study of Efficacy and Safety of AX-8 in Chronic Cough

Chronic Cough Clinical Trial

Official title:

A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866563
• Other study ID #: AX8-003
• Secondary ID: 2021-000844-23
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2021
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: Axalbion SA
• Contact: Chief Medical Officer
• Phone: +41 22 534 94 80
• Email: contact[@]axalbion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Drug:
• AX-8
orally disintegrating tablets, BID
• Placebo
orally disintegrating tablets, BID

Locations

Country	Name	City	State
United Kingdom	Axalbion Study Site 4406	Birmingham	England
United Kingdom	Axalbion Study Site 4404	Broughton	England
United Kingdom	Axalbion Study Site 4409	Chelmsford	England
United Kingdom	Axalbion Study Site 4413	Coventry	England
United Kingdom	Axalbion Study Site 4401	London	England
United Kingdom	Axalbion Study Site 4402	London	England
United Kingdom	Axalbion Study Site 4410	London	England
United Kingdom	Axalbion Study Site 4403	Manchester	England
United Kingdom	Axalbion Study Site 4408	Newport	Wales
United Kingdom	Axalbion Study Site 4405	North Shields	England
United Kingdom	Axalbion Study Site 4407	Oxford	England
United Kingdom	Axalbion Study Site 4411	Preston	England
United Kingdom	Axalbion Study Site 4412	Shipley	England

Sponsors (1)

Lead Sponsor	Collaborator
Axalbion SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of number of coughs per hour to be evaluated using a digital recording device	Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
Secondary	Change from Baseline in awake cough frequency	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	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
Secondary	Change from Baseline in Cough Severity Visual Analog Scale (VAS) score	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").	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
Secondary	Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)	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).	From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)
Secondary	Incidence (percent of participants) of serious adverse events (SAEs)	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.	From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)