EUCTR2006-003500-19-GB进行中（未招募）不适用
A multi-centre, randomised, double-blind, double-dummy,placebo-controlled, 3-way crossover, incomplete block designstudy to investigate the efficacy, safety, tolerability,pharmacodynamics and pharmacokinetics of three inhaled dosesof GSK233705 (10, 20 and 50mcg twice daily) administeredconcurrently with salmeterol 50mcg twice daily, and salmeterol50mcg twice daily alone, in subjects with chronic obstructivepulmonary disease (COPD)
GlaxoSmithKline Research and Development0 个研究点开始时间: 2006年9月29日最近更新:
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- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
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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 or female subjects aged 40 – 75 y inclusive at the Screening Visit 1.
- •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. Male subjects must also agree 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. An established clinical history of COPD at Screening Visit 2, in accordance with the
- •following definition by the American Thoracic Society/European Respiratory
- •Society (ATS/ERS) [Celli, 2004]
- •Chronic obstructive pulmonary disease (COPD) is a preventable and treatable
- •disease characterised by airflow limitation that is not fully reversible. The airflow
- •limitation is usually progressive and is associated with an abnormal inflammatory
- •response of the lungs to noxious particles or gases, primarily caused by cigarette
- •smoking. Although COPD affects the lungs, it also produces significant systemic
- •consequences.
- •5. Post-bronchodilator FEV1 of = 40% to = 75% of predicted normal at Screening
- •Visit 2. Subjects who do not have FEV1 values within this range at Visit 2 may have
- •one repeat assessment at Visit 2A to establish eligibility before randomisation (Visit
- •3). Subjects who do not have FEV1 values within this range will not be eligible for
- •6. Subject has post-bronchodilator FEV1/FVC ratio = 70% at Screening Visit 2.
- •7. Subject must be responsive 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 Screening Visit 1,
- •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 the Screening
- •Visit 1 and an increase in FEV1 of >6% and >100 mL 2 h following inhalation of
- •80 µg of ipratropium bromide at Screening Visit 1 (in order to allow for potential fluctuations in the response to ipratropium bromide in patients known to be
- •responders to ipratropium bromide).
- •Subjects who do not demonstrate the required increase in FEV1 in response to
- •ipratropium at Screening Visit 1 may have the assessment repeated once at
- •Visit 1A, before randomisation (Visit 3). Subjects who do not demonstrate the
- •required increase in FEV1 are not eligible to enter the study.
- •8. Subjects must be responsive to salbutamol defined as:
- •Either: an increase in FEV1 of = 12% and = 150 mL at 30 mins following
- •inhalation of 400 µg of salbutamol at Screening Visit 2, or
- •or: a documented increase in FEV1 of = 12% and = 150 mL at 30 mins following
- •inhalation of 400 µg of salbutamol within 6 months of Screening Visit 1 and an
- •increase in FEV1 of >6% and >100 mL 30 mins following inhalation of
- •salbutamol 400 µg at Screening Visit 2 (in order to allow for poten
排除标准
- •Subjects with any of the following criteria must not be enrolled in the study:
- •1. COPD exacerbation, or changes in COPD medication (other than use of relief
- •VENTOLIN™) within the 4 weeks prior to Screening Visit 2 or during the run-in
- •2. Received antibiotic therapy for either a lower respiratory tract infection or for COPD
- •exacerbation within the 4 weeks prior to Screening Visit 2 or during the run-in
- •3. Hospitalised for a COPD exacerbation in the 6 months prior to Screening Visit 2 or
- •during the run-in period.
- •4. Current diagnosis of asthma or a post-salbutamol increase in lung function of
- •>500 mL at any reversibility assessment prior to randomisation (Visit 3).
- •5. Known respiratory disorders other than COPD (e.g., lung cancer, sarcoidosis,
- •tuberculosis, bronchiectasis, lung fibrosis).
- •6. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck
- •obstruction that in the opinion of the Investigator should prevent them from entering
- •7. Undergone lung surgery (e.g., lung transplant and/or lung volume reduction) which
- •in the opinion of the investigator may affect the outcome of the study.
- •8. Currently receiving pulmonary rehabilitation.
- •9. Had a chest X-ray indicating diagnosis other than COPD that might interfere with the
- •study (in the 12 months prior to the Screening Visit 2).
- •10. Requires regular (daily) or long term oxygen therapy (LTOT).
- •11. Experienced two or more COPD exacerbations requiring treatment with oral,
- •parenteral or depot corticosteroids in the last 6 months.
- •12. Received oral or parenteral corticosteroids within 4 weeks or depot corticosteroids
- •within the 3 months prior to Screening Visit 2 or during the run-in period.
- •13. Receiving inhaled corticosteroids at a dose greater than 1000 µg / day of fluticasone
- •propionate (FP) or equivalent during the run-in period or who changed dose within
- •6 weeks of Screening Visit 2 or during the run-in period.
- •14. Currently receiving ß-blockers (except eye drops).
- •15. Any of the following cardiovascular criteria:
- •a. History of significant congestive heart failure (greater than New York Heart
- •Association Type I), myocardial infarction, ischaemic heart disease requiring
- •regular therapy with drugs other than nitrates or clinically significant cardiac
- •arrhythmia.
- •b. Mean QTc(B) at screening of > 440 msec, the QTc(B) of all three screening
- •ECGs at the Screening Visit 2 are not within 10% of the mean, a PR interval
- •outside the range 90-220 msec or an ECG that is not suitable for QT
- •measurements (e.g., poorly defined termination of the T wave or left bundle
- •branch block).
- •c. History of elevated supine blood pressure or mean blood pressures
- •= 160/90 mmHg at Screening Visit 2.
- •d. Mean heart rate outside the range 50–90 bpm at Screening Visit 2.
- •16. Subjects who are not considered able to tolerate three 2-week wash-out periods
- •according to the study schedule with all COPD medications removed apart from
- •relief use of VENTOLIN via metered dose inhaler (MDI) or
- •DISKUS/ACCUHALER (inhaled use as required) or inhaled corticosteroids at a
- •dose less than 1000 µg / day of fluticasone propionate (FP) or equivalent.
- •17. The subject has a positive drugs of abuse test at Screening Visit 2.
- •18. A positive alcohol test (breath or urine), including ethanol. The detection of alcohol
- •would not be an exclusion at any of the screening visits but the subject would need to
- •provide a negative test result pre-dose and during the study.
- •19. A suspected history of alcohol
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