A Study of Efficacy and Safety of AX-8 in Chronic Cough
NCT ID: NCT04866563
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2021-08-11
2025-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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AX-8 to Placebo, Part 1 of the study
AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
AX-8, Part 1 of the study
orally disintegrating tablets, BID
Placebo, Part 1 of the study
orally disintegrating tablets, BID
Placebo to AX-8, Part 1 of the study
Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
AX-8, Part 1 of the study
orally disintegrating tablets, BID
Placebo, Part 1 of the study
orally disintegrating tablets, BID
AX-8 to Placebo, Part 2 of the study
AX-8 TID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
AX-8, Part 2 of the study
orally disintegrating tablets, TID
Placebo, Part 2 of the study
orally disintegrating tablets, TID
Placebo to AX-8, Part 2 of the study
Placebo TID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
AX-8, Part 2 of the study
orally disintegrating tablets, TID
Placebo, Part 2 of the study
orally disintegrating tablets, TID
Interventions
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AX-8, Part 1 of the study
orally disintegrating tablets, BID
Placebo, Part 1 of the study
orally disintegrating tablets, BID
AX-8, Part 2 of the study
orally disintegrating tablets, TID
Placebo, Part 2 of the study
orally disintegrating tablets, TID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Axalbion SA
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Axalbion Therapeutics, LTD.
Locations
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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 4405
North Shields, England, United Kingdom
Axalbion Study Site 4417
Orpington, 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, United Kingdom
Axalbion Study Site 4408
Newport, Wales, United Kingdom
Axalbion Study Site 4414
Belfast, , United Kingdom
Axalbion Study Site 4415
Northwood, , United Kingdom
Countries
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Other Identifiers
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2021-000844-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AX8-003
Identifier Type: -
Identifier Source: org_study_id
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