EUCTR2008-000725-18-GB进行中（未招募）不适用
A randomised, double-blind, crossover study to investigate the bronchodilatation post-inhalation of GSK961081 alone and with the addition of cumulative doses of short acting bronchodilators (salbutamol and ipratropium bromide) in patients with COPD
GlaxoSmithKline Reaseach & Development0 个研究点目标入组 45 人开始时间: 2008年2月22日最近更新:
适应症
相关药物
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
- •A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- •1. Subject is male or female (of non-child bearing potential) = 40 years of age and = 75 years of age.
- •Non- child bearing potential is defined as physiologically incapable of becoming pregnant, including females who are post-menopausal (more than 2 years without
- •menses with appropriate clinical history i.e. age, history of vasomotor symptomsestradiol and FSH levels may be checked if indicated) and females who are
- •surgically sterile (hysterectomy, tubal ligation or bilateral oophorectomy).
- •2. Subject diagnosed with COPD in accordance with ATS/ERS guidelines.
- •3. Subject is a smoker or an ex-smoker with a history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent)
- •4. Subject has FEV1/FVC < 0.7 post-bronchodilator (salbutamol)
- •5. Subject has FEV1 < 80 % of predicted normal for height, age, gender after inhalation of salbutamol
- •6. Response to ipatropium bromide defined as:
- •Either an increase in FEV1 of > 12 % and > 150 mL within 2 hours following
- •inhalation of 80 µg ipratopium bromide (Atrovent MDI via spacer) at the screening
- •Or: a documented increase in FEV1 of >12 % and > 150 mL within 2 hours
- •following inhalation of 80 µg ipratopium bromide within 6 months of screening and
- •an increase in FEV1 of > 6 % and > 100 mL within 2h following inhalation of 80 µg
- •ipratopium bromide (Atrovent MDI via spacer) 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)
- •7. Response to salbutamol defined as:
- •Either an increase in FEV1 of > 12 % and > 150 mL within 2 hours following
- •inhalation of 400 µg salbutamol MDI (via spacer) at the screening visit
- •Or: a documented increase in FEV1 of >12 % and > 150 mL within 2 hours
- •following inhalation of 400 µg salbutamol MDI within 6 months of screening and an
- •increase in FEV1 of > 6 % and >100 mL within 2h following inhalation of 400 µg
- •salbutamol MDI (via spacer) at the screening visit (in order to allow for potential
- •fluctuations in the response to salbutamol in patients known to be responders to
- •salbutamol)
- •8. Body mass index (BMI) within the range 18-35 kg/m2
- •9. Subject is able and willing to give written informed consent to take part in the study.
- •10. Subject is available to complete all study assessments
- •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
- •A subject will not be eligible for inclusion in this study if any of the following criteria
- •1. Subjects who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
- •2. Subjects with clinically relevant findings on laboratory safety tests.
- •3. Women who are pregnant or lactating
- •4. An unwillingness of subjects to abstain from sexual intercourse with pregnant or
- •lactating women; or an unwillingness of the subject to use a condom/spermicide in
- •addition to having their female partner use another form of contraception such as
- •IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone,
- •subdermal implants or tubal ligation if the woman could become pregnant from the
- •time of the first dose study medication until 90 days post-dose
- •5. The subject has a positive urine drugs of abuse screen.
- •6. A history, or suspected history, of alcohol abuse within the 6 months before the
- •screening visit.
- •7. A positive test for hepatitis C antibody, hepatitis B surface antigen, or HIV.
- •8. The subject has participated in a clinical study with another New Chemical Entity
- •within the past 2 months or participated in a clinical study with any other drug during
- •the previous month.
- •9. The subject has donated a unit of blood within the 56 days of dosing or intends to
- •donate within 56 days after completing the study.
- •10. Subject has an FEV1 < 40 % of predicted for age, height and gender after inhalation of salbutamol.
- •11. The subject has a diagnosis of active tuberculosis, lung cancer, sarcoidosis,
- •bronchiectasis, lung fibrosis, pulmonary hypertension or with a primary diagnosis of
- •12. The subject has a known allergy or hypersensitivity to ipratropium bromide,
- •salbutamol, or lactose
- •13. A subject in whom ipratropium bromide or salbutamol is contraindicated
- •14. Subjects with lung volume reduction surgery within 12 months of screening
- •15. Poorly controlled COPD as defined in the protocol
- •16. Subject has had a respiratory tract infection in the 4 weeks before screening
- •17. Subject requires treatment with inhaled cromolyn sodium, theophyline, oral ß2-
- •agonists, nebulised anticholinergics or leukotriene antagonists
- •18. Subject is unable to abstain from long acting ß2-agonist from 72 hours before
- •screening and throughout the dosing period
- •19. Subject is unable to abstain from tiotropium bromide from 28 days before screening and throughout the dosing period
- •20. Subject is predicted to be unable to abstain from short acting inhaled ß2-agonists or short acting antimuscarinics for 6 hours before screening and for 6 hours before dosing with GSK961081 until all post-dose lung function tests have been completed for a given study day.
- •21. Subject has received oral corticosteroids within the 6 weeks before screening
- •22. Subject is receiving > 1000 µg FP (or equivalent) a day of inhaled corticosteroid or has changed dose within the 6 weeks before screening or is predicted not to be able to maintain a constant dose during the study
- •23. Subject is receiving oxygen therapy or nocturnal positive pressure treatment
- •24. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholinergic
- •25. The subject is unable to use the dosing devices (MDPI/ MDI/ spacer) correctly.
- •26. Subject with carcinoma that has not been in complete remission for at least 5
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