Chronic CoughPhase 2NCT04866563
A Study of Efficacy and Safety of AX-8 in Chronic Cough
A Phase 2 study testing AX-8, Part 1 of the study and AX-8, Part 2 of the study in people with Chronic Cough, run by Axalbion SA at 16 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Cough
- What is being tested?
- AX-8, Part 1 of the study and AX-8, Part 2 of the study
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- 11 Aug 2021to 16 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United Kingdom16 sites
Axalbion Study Site 4414
Belfast, BT9 7AB
Axalbion Study Site 4406
Birmingham, England, B9 5SS
Axalbion Study Site 4404
Broughton, England, DN20 0HR
Axalbion Study Site 4409
Chelmsford, England, CM1 7ET
Axalbion Study Site 4413
Coventry, England, CV3 4FJ
Axalbion Study Site 4401
London, England, SE5 9RS
Axalbion Study Site 4402
London, England, SW3 6HP
Axalbion Study Site 4410
London, England, W2 1NY
Axalbion Study Site 4403
Manchester, England, M23 9LT
Axalbion Study Site 4408
Newport, Wales, NP20 2EF
Axalbion Study Site 4405
North Shields, England, NE29 8NH
Axalbion Study Site 4415
Northwood, HA6 2RN
Axalbion Study Site 4417
Orpington, England, BR5 3QG
Axalbion Study Site 4407
Oxford, England, OX3 9DU
Axalbion Study Site 4411
Preston, England, PR2 9HT
Axalbion Study Site 4412
Shipley, England, BD18 3SA
About this study
Official title: A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough
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.
- Conditions
- Chronic Cough
- Being tested
- AX-8, Part 1 of the study, Placebo, Part 1 of the study, AX-8, Part 2 of the study, Placebo, Part 2 of the study
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AX-8, Part 1 of the studyDrug
orally disintegrating tablets, BID
Placebo, Part 1 of the studyDrug
orally disintegrating tablets, BID
AX-8, Part 2 of the studyDrug
orally disintegrating tablets, TID
Placebo, Part 2 of the studyDrug
orally disintegrating tablets, TID
| Study group | Role | What they receive |
|---|---|---|
| AX-8 to Placebo, Part 1 of the study | Experimental | AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks. Receives: Drug: AX-8, Part 1 of the study; Drug: Placebo, Part 1 of the study |
| Placebo to AX-8, Part 1 of the study | Experimental | Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks. Receives: Drug: AX-8, Part 1 of the study; Drug: Placebo, Part 1 of the study |
| AX-8 to Placebo, Part 2 of the study | Experimental | AX-8 TID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks. Receives: Drug: AX-8, Part 2 of the study; Drug: Placebo, Part 2 of the study |
| Placebo to AX-8, Part 2 of the study | Experimental | Placebo TID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks. Receives: Drug: AX-8, Part 2 of the study; Drug: Placebo, Part 2 of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Assessment of number of coughs per hour to be evaluated using a digital recording device
Measured: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
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
Assessment of number of coughs per hour to be evaluated using a digital recording device
Measured: 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 (4)
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
Measured: 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
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").
Measured: 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
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).
Measured: From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)
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.
Measured: From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start11 Aug 2021
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axalbion SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Axalbion Therapeutics, LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866563
- Sponsor's protocol ID
- AX8-003
- Other IDs
- 2021-000844-23
- Status last verified
- Sep 2025
- First submitted
- 23 Apr 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough
- ClinicalTrials.gov ID
- NCT04866563
- Acronym / sponsor ID
- AX8-003
- Conditions
- Chronic Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Axalbion SAIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AX-8 to Placebo, Part 1 of the study | Experimental | Drug: AX-8, Part 1 of the study, Drug: Placebo, Part 1 of the studyAX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks. |
| Placebo to AX-8, Part 1 of the study | Experimental | Drug: AX-8, Part 1 of the study, Drug: Placebo, Part 1 of the studyPlacebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks. |
| AX-8 to Placebo, Part 2 of the study | Experimental | Drug: AX-8, Part 2 of the study, Drug: Placebo, Part 2 of the studyAX-8 TID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks. |
| Placebo to AX-8, Part 2 of the study | Experimental | Drug: AX-8, Part 2 of the study, Drug: Placebo, Part 2 of the studyPlacebo TID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AX-8, Part 1 of the studyorally disintegrating tablets, BID | Drug | AX-8 to Placebo, Part 1 of the study, Placebo to AX-8, Part 1 of the study |
| Placebo, Part 1 of the studyorally disintegrating tablets, BID | Drug | AX-8 to Placebo, Part 1 of the study, Placebo to AX-8, Part 1 of the study |
| AX-8, Part 2 of the studyorally disintegrating tablets, TID | Drug | AX-8 to Placebo, Part 2 of the study, Placebo to AX-8, Part 2 of the study |
| Placebo, Part 2 of the studyorally disintegrating tablets, TID | Drug | AX-8 to Placebo, Part 2 of the study, Placebo to AX-8, Part 2 of the study |
Primary outcome
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
Time frame: 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
Time frame: 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
4 secondary outcomes
Change from Baseline in awake cough frequency
Time frame: 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
Change from Baseline in Cough Severity Visual Analog Scale (VAS) score
Time frame: 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
Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)
Time frame: From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)
Incidence (percent of participants) of serious adverse events (SAEs)
Time frame: From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Axalbion Therapeutics, LTD.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AX-8, Part 1 of the study and AX-8, Part 2 of the study in people with Chronic Cough, run by Axalbion SA at 16 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.