EUCTR2014-001972-70-BE进行中（未招募）1 期
A randomised, double-blind (sponsor unblinded), placebocontrolled, parallel-group, multicentre study to evaluate the efficacy and safety of GSK2269557 administered in addition to standard of care in adult subjects diagnosed with an acute exacerbation of Chronic Obstructive Pulmonary Disease.
GlaxoSmithKline Reasearch & Development0 个研究点目标入组 120 人开始时间: 2014年11月3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
- 入组人数
- 120
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
- •-Between 40 and 80 years of age inclusive, at the time of signing the informed consent.
- •2) TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
- •-The subject has a confirmed and established diagnosis of COPD, as defined by the GOLD guidelines for at least 6 months prior to entry.
- •-The subject has a post-bronchodilator FEV1/FVC < 0.7 and FEV1 = 80 % of predicted, documented in the last 5 years.
- •-Disease severity: Acute exacerbation of COPD requiring an escalation in therapy to include corticosteroid and antibiotics. Acute exacerbation to be confirmed by an experienced physician and represent a recent change in at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms.
- •Major symptoms:
- •- Subjective increase in dyspnea
- •- Increase in sputum volume
- •- Change in sputum colour
- •Minor symptoms:
- •- Sore throat
- •The subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years.
- •- Body weight >or= 45 kg and body mass index (BMI) within the range 18 – 32 kg/m2
- •-Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies:
- •1. Non-reproductive potential defined as:
- •-Pre-menopausal females with one of the following:
- •-Documented tubal ligation
- •-Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
- •-Hysterectomy
- •-Documented Bilateral Oophorectomy
- •-Postmenopausal defined as 12 months of spontaneous amenorrhea. Females whose menopausal status is in doubt will be required to use, or have been using, one of the highly effective contraception methods as specified below from 30 days prior to the first dose of study medication and until completion of the follow-up visit.
- •2. Reproductive potential and agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until completion of the follow-up visit.
- •GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP)
- •This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.
- •1. Contraceptive subdermal implant that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label
- •2. Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label
- •3. Oral Contraceptive, either combined or progestogen alone
- •4. Injectable progestogen
- •5. Contraceptive vaginal ring
- •6. Percutaneous contraceptive patches
- •7. Male partner sterilization with documentation of azoospermia prior to the female subject’s entry into the study, and this male is the sole partner for that subject.
- •8. Male condom combined with a vaginal spermicide.
- •These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how t
排除标准
- •1) CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER
- •FUNCTION AND QTC INTERVAL)
- •To avoid recruitment of subjects with a severe COPD exacerbation, the presence of any one of the following severity criteria will render the subject ineligible for inclusion in the study:
- •-Need for invasive mechanical ventilation (short term (< 48h) NIV or CPAP is acceptable)
- •-Haemodynamic instability or clinically significant heart failure
- •-Confusion
- •-Clinically significant pneumonia, identified by chest X-ray (if available) or on the CT scan performed during screening, as judged by the Investigator and in
- •consultation with the GSK Medical Monitor, if required. (NOTE: Since CT is more sensitive than X-ray for detecting pneumonia, minor patches of infection or bronchopneumonia seen on CT at screening are expected and therefore allowed.)
- •-Subjects who have a history or current medical conditions or diseases that are not well controlled and, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. (Note: Patients with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or NIDDM) are permitted to be entered into the study).
- •-Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt
- •bronchiectasis, pulmonary fibrosis, asthma or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.
- •-ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if
- •bilirubin is fractionated and direct bilirubin <35%).
- •-A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the exclusion criteria, outside of the reference range for the population being studied may be included if the Investigator [in consultation with the
- •GSK Medical Monitor if required] documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- •-Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
- •- ECG indicative of an acute cardiac event (e.g. Myocardial Infarction) or demonstrating a clinically significant arrhythmia requiring treatment.
- •-QTcF > 450 msec or QTcF > 480 msec in subjects with Bundle Branch Block, based on single QTcF value.
- •-Subjects who have undergone lung volume reduction surgery.
- •20 CONCOMITANT MEDICATIONS
- •-Subject is currently on chronic treatment with macrolides; long term oxygen therapy (> 15 hours/day).
- •-The subject has been on chronic treatment with anti-Tumour Necrosis Factor (anti-
- •TNF), anti-Interleukin-1 (anti-IL1), or any other immunosuppressive therapy within
- •60 days prior to dosing.
- •3) RELEVANT HABITS
- •-History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >28 units for males or >21 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- •4) CONTRAINDICATIONS
- •-History of sensitivity to any of the study medications, or components thereof (such as lactose) or a history of drug or other allergy that, in the opinion of the investigator or
- •Medical Monitor, contraindicates their participation.
- •5) DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
- •-A known (historical) positive t
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