EUCTR2013-004041-17-GB进行中（未招募）1 期
A double-blind, randomised, placebo-controlled, crossover study to assess the efficacy of XEN-D0501, a TRPV1 antagonist, in reducing the frequency of cough in patients with chronic obstructive pulmonary disease.
Xention Limited0 个研究点开始时间: 2013年11月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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) <80% of the predicted normal value and a ratio between FEV1 and forced vital capacity (FVC) <0.7 after 4 puffs (4 x 100 µg) of salbutamol (via pressurized metered-dose inhaler [pMDI]).
- •2. Day time cough frequency >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
排除标准
- •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 <6 months,
- •4. Upper respiratory tract infection within the last 6 weeks prior to randomisation (Visit 4),
- •5. COPD exacerbation requiring treatment within 6 weeks prior to randomisation (Visit 4),
- •6. Evidence of active microbial respiratory infection defined as the presence of significant pathogenic bacteria on sputum culture (assessed by colony forming units) at Visit 1,
- •7. Feverish illness within the last 1 week prior to randomisation (Visit 4),
- •8. Concomitant medications which may influence cough e.g. opioids, gabapentin, pregabalin, amitriptyline, ACE inhibitors, and those drugs listed in section 9.8.3
- •9. Use of systemic corticosteroids within 3 months of Visit 1,
- •10. Patient with concomitant conditions which may influence the cough reflex or the patient’s ability to participate in the study e.g. diabetes, cerebrovascular disease, Parkinson’s disease. N.B. Patients with type 2 diabetes may be included if, in the opinion of the investigator, they are well controlled and have no history suggestive of autonomic neuropathy;
- •11. History of drug or alcohol dependency or abuse within approximately the last year prior to Visit 1,
- •12. Regular alcohol consumption; >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.
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