EUCTR2006-001419-30-SE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, dose ascending, 3 period crossover study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat inhaled doses of GSK233705B in COPD subjects.
GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 45 人开始时间: 2006年7月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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. Men or women who are between 40 and 75 years of age
- •2. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •3. Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or unwillingness of male subjects to use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
- •4. Subject diagnosed with COPD, as defined by the GOLD guidelines.
- •5. Body weight = 50kg
- •6. Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years
- •(1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
- •7. Subject has FEV1/FVC < 0.7 post-bronchodilator (salbutamol).
- •8. Subject has FEV1 = 80% of predicted normal for height, age and gender after inhalation of 200 µg salbutamol.
- •9. Response to ipratropium bromide defined as:
- •Either: An increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 µg of ipratropium bromide at the screening visit
- •or: a documented increase in FEV1 of =12% and =150 mL at 2 h following inhalation of 80 µg of ipratropium bromide within 6 months of screening and an increase in FEV1 of >6% and >100ml 2h following inhalation of 80 µg of ipratropium bromide at the screening visit (in order to allow for potential fluctuations in the response to ipratropium bromide in patients known to be responders to ipratropium bromide).
- •10. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •11. Subject is available to complete all study measurements and procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, may affect the outcome of this study.
- •2. The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study.
- •3. History of alcohol/drug abuse or dependence within 12 months of the study: Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
- •4. The subject has a positive pregnancy test.
- •5. Subject has FEV1 < or = 40% of predicted after inhalation of salbutamol.
- •6. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •7. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication.
- •8. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •9. Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
- •10. The subject has donated a unit of blood within 30 days of screening, or, intends to donate during the study.
- •11. Subject has claustrophobia that may be aggravated by entering the plethysmography cabinet.
- •12. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of its derivatives or milk protein/lactose.
- •13. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
- •14. Subject is unable to use the DISKUS™ device correctly.
- •15. Subject has prostate hypertrophy or narrow angle glaucoma.
- •16. Use of prescription (with the exceptiion of those allowed in the protocol) and herbal remedies (e.g. St John'sWort) within 48 hours or 5 half-lives (whichever is longer) prior to each treatment period, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety
研究者
相似试验
已完成
不适用
A randomised, double-blind, placebo-controlled, dose-escalation study of multiple doses of BIIB014 administered orally in subjects with early Parkinson's diseaseParkinson's diseaseISRCTN55858075Biogen Idec Ltd (USA)40
进行中（未招募）
不适用
A randomised, double-blind, placebo-controlled, dose ascending, 3 period crossover study to examine the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat inhaled doses of GSK233705B in COPD subjects.Study is in COPD patientsEUCTR2006-001419-30-BEGlaxoSmithKline Research and Development Ltd45
进行中（未招募）
1 期
A study of MEDI7352 in painful diabetic neuropathyPainful diabetic neuropathyMedDRA version: 20.0Level: PTClassification code 10012680Term: Diabetic neuropathySystem Organ Class: 10029205 - Nervous system disordersEUCTR2018-002523-42-ESAstraZenecaAB271
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, dose ascending, 2-cohort, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice-daily inhaled doses of GSK233705B formulated with the excipient Magnesium Stearate in COPD subjects for 7-days. - GSK233705B pk and pd study in COPD patientsStudy is in COPD patients.MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2006-006083-33-NLGlaxoSmithKline Research and Development Ltd
进行中（未招募）
1 期
A study of MEDI7352 in painful diabetic neuropathyEUCTR2018-002523-42-PLAstraZenecaAB272