EUCTR2007-004807-37-EE进行中（未招募）不适用
Study B2C111045, A Dose-Finding Study of GW642444 versus Placebo in Patients with COPD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 576
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
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Informed Consent: Subjects who give their signed written informed consent to
- •participate.
- •2. Gender: Male or females who are 40 - 80 years of age at Visit 1.
- •A female is eligible to enter and participate in the study if she is of:
- •Non-child bearing potential (i.e. physiologically incapable of becoming pregnant,
- •including any female who is post-menopausal); or
- •Child bearing potential, has a negative pregnancy test at screening, and agrees to
- •one of the following acceptable contraceptive methods used consistently and
- •correctly (i.e. in accordance with the approved product label and the instructions of
- •the physician for the duration of the study – screening to follow-up contact):
- •Complete abstinence from intercourse from screening until 2 weeks after the
- •follow-up contact; or
- •Male partner is sterile (vasectomy with documentation of azoospermia) prior to
- •female subject entry into the study, and this male partner is the sole partner for
- •that subject; or
- •Implants of levonorgestral inserted for at least 1 month prior to the study
- •medication administration but not beyond the third successive year following
- •insertion; or
- •Injectable progestogen administered for at least 1 month prior to study
- •medication administration and administered for 1 month following study
- •completion; or
- •Oral contraceptive (combined or progestogen only) administered for at least one
- •monthly cycle prior to study medication administration; or
- •Double barrier method: condom or occlusive cap (diaphragm or cervical/vault
- •caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
- •An intrauterine device (IUD), inserted by a qualified physician, with published
- •data showing that the highest expected failure rate is less than 1% per year; or
- •Estrogenic vaginal ring; or
- •Percutaneous contraceptive patches
- •3. COPD Diagnosis: Subjects with an established clinical history of COPD in
- •accordance with the following definition by the American Thoracic
- •Society/European Respiratory Society [Celli, 2004]:
- •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.
- •4. Tobacco Use: Must have current or prior history of at least 10 pack-years of
- •cigarette smoking. [number of pack years = (number of cigarettes per day / 20) x
- •number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- •5. Severity of Disease:
- •Subjects with a measured post-salbutamol FEV1/FVC ratio of =0.70 at Visit 1
- •(Screening).
- •Subjects with a measured post-salbutamol FEV1 =35 and =70% of predicted
- •normal values calculated using NHANES III reference equations at Visit 1
- •(Screening).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- 另有 3 项未显示
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Pregnancy: Women who are pregnant or lactating.
- •2. Asthma: Subjects with a primary diagnosis of asthma. (Subjects with a prior
- •history of asthma are eligible if COPD is currently their primary diagnosis)
- •3. a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD.
- •4. Other Respiratory disorders: Subjects with active tuberculosis, lung cancer,
- •bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung
- •disease or other active pulmonary disease.
- •5. Lung Resection: Subjects with lung volume reduction surgery within the previous
- •6. Chest X-ray: Chest X-ray (or CT scan) reveals evidence of clinically significant
- •abnormalities not believed to be due to the presence of COPD. Please view protocol for further information.
- •7. Hospitalization: Subjects who are hospitalized due to poorly controlled COPD
- •within 12 weeks of the screening visit.
- •8. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the
- •occurrence of any of the following in the 6 weeks prior to Visit 1:
- •acute worsening of COPD that is managed by subject with corticosteroids or
- •antibiotics, or
- •acute worsening of COPD that requires treatment prescribed by a physician
- •9. Other Diseases/Abnormalities: Subjects with clinically significant cardiovascular
- •neurological, psychiatric, renal, immunological, endocrine (including uncontrolled
- •diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
- •10. Lower Respiratory Tract Infection: Subjects with lower respiratory tract
- •infections which required the use of antibiotics within 6 weeks prior to visit 1.
- •11. 12-Lead ECG: An abnormal and clinically significant 12-lead electrocardiogram
- •(ECG) that results in an active medical problem. For the purposes of this study, an
- •abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not
- •limited to) any of the following: Please view protocol for further information.
- •A mean QTc(B) value at screening >450msec, or uncorrected QT>600msec or an
- •ECG that is not suitable for QT measurements (e.g. poorly defined termination
- •of the T wave) Please view protocol for further information.
- •12. Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
- •13. Hepatitis: Subjects with a positive Hepatitis B surface antigen or positive hepatitis C antibody pre-study or at Screening.
- •14. Cancer: Subjects with carcinoma that has not been in complete remission for at
- •least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal
- •cell carcinoma would not be excluded if the subject was considered cured in less than 5 years since diagnosis.
- •15. Drug allergy: Subjects with a history of hypersensitivity to any beta-agonist or any component of the MDI and/or nebule or sensitivity to any of the constituents of the dry powder product (magnesium stearate or lactose). In addition patients with a
- •history of severe milk protein allergy would also be excluded.
- •16. Drug abuse: Subjects with a known or suspected history of alcohol or drug abuse
- •within the last 2 years.
- •17. Medication prior to spirometry: Subjects who are medically unable to withhold
- •their salbutamol for the 6 hour period required prior to spirometry testing at each
- •study visit would be ineligible for the study.
- •18. Additional Medications: The following medications are not permitted during this
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