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

Primary Purpose

Chronic Cough

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AX-8
Placebo
Sponsored by
Axalbion SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Axalbion Study Site 4406
  • Axalbion Study Site 4404Recruiting
  • Axalbion Study Site 4409Recruiting
  • Axalbion Study Site 4413Recruiting
  • Axalbion Study Site 4401Recruiting
  • Axalbion Study Site 4402Recruiting
  • Axalbion Study Site 4410
  • Axalbion Study Site 4403Recruiting
  • Axalbion Study Site 4405Recruiting
  • Axalbion Study Site 4407Recruiting
  • Axalbion Study Site 4411
  • Axalbion Study Site 4412
  • Axalbion Study Site 4408

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AX-8 to Placebo

Placebo to AX-8

Arm Description

AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.

Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.

Outcomes

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
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
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
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)
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)
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.

Full Information

First Posted
April 23, 2021
Last Updated
July 19, 2023
Sponsor
Axalbion SA
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1. Study Identification

Unique Protocol Identification Number
NCT04866563
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axalbion SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AX-8 to Placebo
Arm Type
Experimental
Arm Description
AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
Arm Title
Placebo to AX-8
Arm Type
Experimental
Arm Description
Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AX-8
Intervention Description
orally disintegrating tablets, BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally disintegrating tablets, BID
Primary Outcome Measure Information:
Title
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
Description
Assessment of number of coughs per hour to be evaluated using a digital recording device
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
Secondary Outcome Measure Information:
Title
Change from Baseline in awake cough frequency
Description
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
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
Title
Change from Baseline in Cough Severity Visual Analog Scale (VAS) score
Description
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").
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
Title
Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)
Description
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).
Time Frame
From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included)
Title
Incidence (percent of participants) of serious adverse events (SAEs)
Description
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.
Time Frame
From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Medical Officer
Phone
+41 22 534 94 80
Email
contact@axalbion.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Scientific Officer
Phone
+41 22 534 94 80
Email
contact@axalbion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Axalbion Therapeutics, LTD.
Official's Role
Study Director
Facility Information:
Facility Name
Axalbion Study Site 4406
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Axalbion Study Site 4404
City
Broughton
State/Province
England
ZIP/Postal Code
DN20 0HR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4409
City
Chelmsford
State/Province
England
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4413
City
Coventry
State/Province
England
ZIP/Postal Code
CV3 4FJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4401
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4402
City
London
State/Province
England
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4410
City
London
State/Province
England
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Axalbion Study Site 4403
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4405
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4407
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
contact@axalbion.com
Facility Name
Axalbion Study Site 4411
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Axalbion Study Site 4412
City
Shipley
State/Province
England
ZIP/Postal Code
BD18 3SA
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Axalbion Study Site 4408
City
Newport
State/Province
Wales
ZIP/Postal Code
NP20 2EF
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No

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

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