Trial record 1 of 1 for:
04866563
A Study of Efficacy and Safety of AX-8 in Chronic Cough
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| ClinicalTrials.gov Identifier: NCT04866563 |
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Recruitment Status :
Recruiting
First Posted : April 30, 2021
Last Update Posted : July 19, 2022
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Sponsor:
Axalbion SA
Information provided by (Responsible Party):
Axalbion SA
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Cough | Drug: AX-8 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough |
| Actual Study Start Date : | August 11, 2021 |
| Estimated Primary Completion Date : | December 2022 |
| Estimated Study Completion Date : | March 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: AX-8 to Placebo
AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
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Drug: AX-8
orally disintegrating tablets, BID Drug: Placebo orally disintegrating tablets, BID |
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Experimental: Placebo to AX-8
Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
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Drug: AX-8
orally disintegrating tablets, BID Drug: Placebo orally disintegrating tablets, BID |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 ]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 [ 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 ]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) [ Time Frame: 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) [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866563
Contacts
| Contact: Chief Medical Officer | +41 22 534 94 80 | contact@axalbion.com | |
| Contact: Chief Scientific Officer | +41 22 534 94 80 | contact@axalbion.com |
Locations
| United Kingdom | |
| Axalbion Study Site 4406 | Completed |
| Birmingham, England, United Kingdom, B9 5SS | |
| Axalbion Study Site 4404 | Recruiting |
| Broughton, England, United Kingdom, DN20 0HR | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4409 | Recruiting |
| Chelmsford, England, United Kingdom, CM1 7ET | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4413 | Recruiting |
| Coventry, England, United Kingdom, CV3 4FJ | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4401 | Recruiting |
| London, England, United Kingdom, SE5 9RS | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4402 | Recruiting |
| London, England, United Kingdom, SW3 6HP | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4410 | Completed |
| London, England, United Kingdom, W2 1NY | |
| Axalbion Study Site 4403 | Recruiting |
| Manchester, England, United Kingdom, M23 9LT | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4405 | Recruiting |
| North Shields, England, United Kingdom, NE29 8NH | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4407 | Recruiting |
| Oxford, England, United Kingdom, OX3 9DU | |
| Contact contact@axalbion.com | |
| Axalbion Study Site 4411 | Completed |
| Preston, England, United Kingdom, PR2 9HT | |
| Axalbion Study Site 4412 | Completed |
| Shipley, England, United Kingdom, BD18 3SA | |
| Axalbion Study Site 4408 | Completed |
| Newport, Wales, United Kingdom, NP20 2EF | |
Sponsors and Collaborators
Axalbion SA
Investigators
| Study Director: | Chief Medical Officer | Axalbion Therapeutics, LTD. |
| Responsible Party: | Axalbion SA |
| ClinicalTrials.gov Identifier: | NCT04866563 |
| Other Study ID Numbers: |
AX8-003 2021-000844-23 ( EudraCT Number ) |
| First Posted: | April 30, 2021 Key Record Dates |
| Last Update Posted: | July 19, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Cough Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |