Chronic Idiopathic Cough MedDRA version: 16.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Interventions
Product Name: XEN-D0501
Product Code: XEN-D0501
Pharmaceutical Form: Tablet
INN or Proposed INN: None
CAS Number: None
Current Sponsor code: XEN-D0501
Other descriptive name: BAY 69-9426, BR4874
Conce
Sponsors
Xention Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 18 years or over with chronic idiopathic cough, defined as: a) Attending a specialist cough clinic with a history of cough for more than 8 weeks b) Idiopathic cough (defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation) or treatment-resistant cough (defined as a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip). 2. Normal chest radiography i.e., chest X-ray or CT thorax, prior to the study (within 12 months of Visit 1) 3. Normal spirometry (i.e. forced expiratory volume in 1 second [FEV1] >80% predicted) 4. Day time cough frequency >1.5 coughs/hour (from 24-hour cough monitor at Visit 3), 5. Emax from capsaicin challenge >10 coughs (from challenge cough monitor at Visit 3), 6. Women must be of non-child bearing potential. a) Non-child bearing potential is defined as amenorrhoeic for at least 1 year AND, if aged under 60 years, have serum follicle stimulating hormone [FSH] level of at least 30 IU/L or have undergone a hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable). Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). b) If female partners of male patients are of childbearing potential, the patient must be willing to use contraception (e.g. condoms plus spermicide) AND their female partner must also be using contraception (e.g. hormonal or intra-uterine device). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug. 7. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) >35 kg/m2, 2. Current smokers or patients with urine cotinine =500 ng/mL, 3. Ex-smoker of 21 units/week for males, or >14 units/week for females, during the study (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine), 11. Any known allergy to the study drugs, 12. Pregnant and/or lactating women, 13. History or evidence of urinary retention, bladder outlet obstruction or benign prostatic hypertrophy, 14. Any clinically significant abnormalities in haematology or clinical biochemistry tests prior to randomisation (Visit 3), 15. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN) at Visit 1, 16. Total serum bilirubin >1.5x ULN at Visit 1, 17. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor, 18. Evidence of any other clinically significant disease or condition which in the opinion of the investigator would preclude the patient’s participation in this study, 19. QTcF value at Visit 1 (mean) of >450 msec (males) or >470 msec (females), 20. Patients with uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at Visit 1 (mean) or Visit 2, 21. Received investigational or marketed products as part of any other clinical study within 30 days (or 5 half-lives whichever is longer) prior to screening (Visit 1), 22. Patient is unable or unwilling to co-operate with the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of XEN-D0501 over placebo in reducing objective daytime cough frequency.;Secondary Objective: To evaluate the effectiveness of XEN-D0501 over placebo using: - capsaicin cough responses, - objective 24-hour cough frequency, - hourly change in cough frequency, - cough severity (via visual analogue scale [VAS]), - urge to cough (via VAS) - global rating of change scale, - Leicester Cough Questionnaire (LCQ),;Primary end point(s): Change from baseline after 14-days treatment in objective daytime cough frequency on XEN-D0501 compared to placebo.;Timepoint(s) of evaluation of this end point: After 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline after 14 days treatment for XEN D0501 compared to placebo for the following parameters: - capsaicin cough response (Emax) - objective 24-hour cough frequency - hourly change in cough frequency - cough severity (VAS) - urge to cough (VAS) - Leicester Cough Questionnaire Difference between XEN-D0501 and placebo after 14 days treatment for : - Global rating of change scale.;Timepoint(s) of evaluation of this end point: 14 Days | — |
Countries
United Kingdom
Contacts
Public ContactChief Medical Officer
Xention Limited
Outcome results
None listed