Clinical trial NCT04866563: A Study of Efficacy and Safety of AX-8 in Chronic Cough
Official title: A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients with Chronic Cough
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Cough
Lead sponsor: Axalbion SA
Sponsor class: INDUSTRY
First posted: 2021-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
measure: 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
timeFrame: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
Secondary outcomes:
measure: Change from Baseline in awake cough frequency
timeFrame: 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
measure: Change from Baseline in Cough Severity Visual Analog Scale (VAS) score
timeFrame: 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
measure: Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)
timeFrame: From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)
measure: Incidence (percent of participants) of serious adverse events (SAEs)
timeFrame: From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Axalbion Study Site 4406
state: England
city: Broughton
country: United Kingdom
facility: Axalbion Study Site 4404
state: England
city: Chelmsford
country: United Kingdom
facility: Axalbion Study Site 4409
state: England
city: Coventry
country: United Kingdom
facility: Axalbion Study Site 4413
state: England
city: London
country: United Kingdom
facility: Axalbion Study Site 4401
state: England
city: London
country: United Kingdom
facility: Axalbion Study Site 4402
state: England
city: London
country: United Kingdom
facility: Axalbion Study Site 4410
state: England
city: Manchester
country: United Kingdom
facility: Axalbion Study Site 4403
state: England
city: North Shields
country: United Kingdom
facility: Axalbion Study Site 4405
state: England
city: Orpington
country: United Kingdom
facility: Axalbion Study Site 4417
state: England
city: Oxford
country: United Kingdom
facility: Axalbion Study Site 4407
state: England
city: Preston
country: United Kingdom
facility: Axalbion Study Site 4411
state: England
city: Shipley
country: United Kingdom
facility: Axalbion Study Site 4412
state: England
city: Newport
country: United Kingdom
facility: Axalbion Study Site 4408
state: Wales
city: Belfast
country: United Kingdom
facility: Axalbion Study Site 4414
city: Northwood
country: United Kingdom
facility: Axalbion Study Site 4415
Study officials:
affiliation: Axalbion Therapeutics, LTD.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: