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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04866563
Recruitment Status : Recruiting
First Posted : April 30, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Axalbion SA

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
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.
Drug: AX-8
orally disintegrating tablets, BID

Drug: Placebo
orally disintegrating tablets, BID

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.
Drug: AX-8
orally disintegrating tablets, BID

Drug: Placebo
orally disintegrating tablets, BID




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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").

  3. 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).

  4. 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
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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
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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
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Study Director: Chief Medical Officer Axalbion Therapeutics, LTD.
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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

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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