Chronic Obstructive Pulmonary Disease. MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: XEN-D0501
Product Code: XEN-D0501
Pharmaceutical Form: Tablet
INN or Proposed INN: Non
CAS Number: Non
Current Sponsor code: XEN-D0501
Other descriptive name: BAY 69-9426
Concentration u
Sponsors
Xention Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged 40 years or over with COPD, defined as: • Smoking history of >10 pack-years, • A post-bronchodilator forced expiratory volume in 1 second (FEV1) 1.5 coughs/hour (from 24-hour cough monitor at Visit 3), 3. For patients recruited to the Capsaicin Challenge Cohort only: - A pre-bronchodilator FEV1 of at least 1.0 L at Visit 1 - Emax from capsaicin challenge >10 coughs (from challenge cough monitor at Visit 3) 4. Women must be of non-child bearing potential. • Non-child bearing potential is defined as amenorrheic 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). 5. 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. 6. 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) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) >40 kg/m2, 2. Current smokers or patients with urine cotinine greater or equal to 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). 13. Any known allergy to the study drugs, 14. Pregnant and/or lactating women, 15. History or evidence of urinary retention, bladder outlet obstruction or benign prostatic hypertrophy, 16. Any clinically significant abnormalities in haematology or clinical biochemistry tests prior to randomisation (Visit 4). 17. Serum alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) greater than twice the upper limit of normal (ULN) at Visits 1 or 2, 18. Total serum bilirubin >1.5x ULN at Visits 1 or 2, 19. History of any kind of cancer within the last 5 years unless non-invasive, in remission and approved in writing by Sponsor, 20. COPD with respiratory failure that requires long term oxygen therapy, 21. 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, 22. QTcF value at Visit 1 (mean) or Visit 2 of >450 msec (males) or >470 msec (females) 23. Patients with uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg at Visit 1 (mean) or Visit 2. 24. Received investigational or marketed products as part of any other clinical study within 30 days (or 5 half-lives whichever is longer) prior to Visit 1, 25. 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.;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: 14 days;Secondary Objective: • To evaluate the effectiveness of XEN-D0501 over placebo in reducing: o capsaicin cough responses, o objective 24-hour cough frequency, o hourly change in cough frequency, o cough severity (via visual analogue scale (VAS)). o urge to cough (via VAS), o global rating of change scale, o Clinical COPD Questionnaire (CCQ), o Leicester Cough Questionnaire (LCQ), o St George's Respiratory Questionnaire (SGRQ-C) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 14 days;Secondary end point(s): Change from baseline after at the end of each treatment period for the following parameters: • Capsaicin cough response (Emax) - Capsaicin Challenge Cohort only • Objective 24-hour cough frequency • Clinical COPD Questionnaire • SGRQ-C • Leicester Cough Questionnaire The assessments at the end of each treatment period for: • Hourly change in cough frequency • Global rating of change scale Change from baseline over each treatment period for the following parameters: • Cough severity (VAS) • Urge to cough (VAS) | — |
Countries
United Kingdom
Contacts
Public ContactChief Medical Officer
Xention Limited
Outcome results
None listed