A pilot study of efficacy, safety and tolerability of AX-8 in cough
- Conditions
- Refractory Chronic Cough (RCC).MedDRA version: 20.0 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000016024Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-003108-27-GB
- Lead Sponsor
- Axalbion SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1. Females and males between 18 and 80 years of age inclusive
2. Have a diagnosis of RCC or unexplained cough for at least one year (see BTS guidelines in Appendix C of the protocol) and associated upper airway symptoms (throat or laryngeal irritation, tickling, dryness or discomfort) of at least 8-week duration. Regular pattern of cough with expected daily episodes of cough that occur throughout the day, as ascertained by medical history.
3. Chest radiograph or CT Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough in the opinion of the Principal Investigator and Axalbion SA Medical Monitor.
4. At Screening have a score of = 40mm on the Cough Severity VAS.
5. At Baseline have a score of = 40mm on the Cough Severity VAS.
6. All female subjects who are of childbearing potential must practice highly effective contraception (i.e. pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial Screening visit until 4 weeks after last dose of study drug. Please refer to Protocol section 7.1.5 for acceptable methods of contraception.
7. BMI < 33kg/m2 at the baseline visit.
8. Have provided written informed consent.
9. Are willing and able to comply with all aspects of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Prior treatment with AX-8.
2. Hypersensitivity or intolerance to AX-8 or other TRPM8 agonists (e.g. menthol, menthol-like compounds), or any of the excipients of AX-8 ODT.
3. Current smoker or individuals who have given up smoking within the past 12 months or ex-smoker with > 20 pack-years.
4. FEV1/FVC < 60%.
5. History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0).
6. History of cystic fibrosis.
7. History of opioid use within 1 week of the Baseline Visit if used for the treatment of RCC. Opioids, if required for other indications are permitted providing that subject are receiving a stable dose for at least 1 week prior to the Baseline visit (Day 0) and are still experiencing a troublesome cough. Subjects must remain on a stable dose for the duration of the study until the follow up visit (in accordance with Protocol section 5.6)
8. Requiring concomitant therapy with prohibited medications (see Protocol section 5.6).
9. Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer.
10. Treatment with any investigational therapy within 4 weeks prior to the Baseline Visit (Day 0).
11. Clinically significant abnormality of hepatic function defined as Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening.
12. Clinically significant abnormality of renal function, defined as e-GFR < 60 ml/min.
13. Positive test for any drug-of-abuse (unless this can be explained by the subject’s medication).
14. History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin.
15. History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt.
16. Known active hepatitis infection.
17. Known history of human immunodeficiency virus (HIV) infection.
18. Presence of any medical condition or disability that, in the investigator’s opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject, including clinically significant ECG abnormalities during screening, baseline (Day 0) or pre-dose (Day 1).
19. Currently pregnant or breastfeeding female subject, or male subject with a pregnant or breastfeeding partner.
20. Females of childbearing potential who are unable or unwilling to practice highly effective contraception (pregnancy prevention).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method