EUCTR2010-020127-52-DE进行中（未招募）不适用
A Phase 2a, double blind, placebo controlled study to evaluate the efficacy of MEDI-563 in subjects with moderate to severe COPD and sputum eosinophilia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
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. Subjects aged 40 to 85 years old at the time of screening.
- •2. Written informed consent obtained from the subject prior to
- •performing any protocol-related procedures.
- •3. Documented history of moderate to severe COPD with a
- •post-bronchodilator FEV1/FVC < 0.70 and a
- •post-bronchodilator FEV1 < 80% predicted at screening.
- •4. Documented history of 1 or more AECOPD that required treatment
- •with systemic corticosteroids and/or antibiotics, or hospitalization
- •within 8 weeks - 52 weeks prior to Day 1.
- •5. Eosinophilia: greater or same as 3.0% demonstrated on sputum
- •within 12 months prior to, or at screening.
- •6. Clinically stable and free from an acute exacerbation of COPD for
- •8 weeks prior to Day 1.
- •7. Current smoker or ex-smoker with a tobacco history of more than
- •or equal to 10 pack-years (1 pack year = 20 cigarettes smoked per
- •day for 1 year).
- •8. Female subjects of childbearing potential who are sexually active
- •with non-sterilized male partner must use adequate contraception
- •from screening through the end of the study. An acceptable
- •method of contraception is defined as one that has no higher than
- •a 1% failure rate. In this study, where medications and devices
- •containing hormones are included, the recommended methods of
- •contraception are described in the protocol. Sustained abstinence is
- •an acceptable practice; however, periodic abstinence, the rhythm
- •method, and the withdrawal method are not acceptable methods
- •of contraception.
- •9. Non-sterilized males who are sexually active with a female of
- •child-bearing potential must use adequate contraception
- •(see protocol) from screening through the end of the study.
- •10. Females not of childbearing potential must have been
- •surgically sterilized (eg. hysterectomy, bilateral tubal ligation,
- •or bilateral oophorectomy) or postmenopausal (defined as at
- •least 1 year since last regular menses) and follicle stimulating
- •hormone (FSH) > 23 IU/L according to a central
- •laboratory.
- •11. Sterilized males must be at least one year post vasectomy or
- •must use adequate contraception (see Table 4.2.1-1) if less than
- •one year post vasectomy.
- •12. Ability and willingness to complete follow-up period as required
- •by the protocol.
- •13. Subjects receiving allergy immunotherapy must be on a stable
- •dose for the preceding 90 days prior to Day 1.
- •14. Able to read and write.
- •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. Any condition that, in the opinion of the investigator, would interfere
- •with evaluation of the investigational product or interpretation of
- •subject safety or study results.
- •2. Significant or unstable ischemic heart disease, arrhythmia,
- •cardiomyopathy, heart failure, renal failure, uncontrolled
- •hypertension as defined by the Investigator, or any other
- •relevant cardiovascular disorder as judged by the Investigator.
- •3. Pregnant, breastfeeding and lactating women.
- •4. Known history of allergy or reaction to any component of the
- •investigational product formulation, budesonide/formoterol
- •preparations, tiotropium bromide or terbutaline sulphate or
- •any of their excipients.
- •5. History of anaphylaxis to any other biologic therapy.
- •6. Donation or transfusion of blood, plasma or platelets within
- •the past 90 days prior to screening.
- •7. Other significant pulmonary disease as a primary diagnosis
- •(eg, cystic fibrosis, bronchiecstasis, alpha-1 antitrypsin
- •deficiency, interstitial lung disease; pulmonary hypertension
- •other than cor pulmonale) if a subject is diagnosed with any
- •other pulmonary disease as a secondary diagnosis, they may
- •be included if, in the opinion of the investigator or medical monitor,
- •the inclusion does not compromise the interpretation of the study.
- •8. Receiving long-term oxygen therapy (LTOT) at entry into the study.
- •LTOT is defined as use of oxygen for a minimum of 15 hours per day.
- •9. Subjects who have a past or present disease or disorder, which is
- •judged by the investigator and the medical monitor, may either put
- •the subject at risk because of participation in the study, or may affect
- •the outcome of the study. Subjects, who have epilepsy, must be on a
- •stable dose of medication for 30 days prior to Day 1.
- •10. Influenza vaccination within 3 weeks before sputum collection at
- •screening (Day -56).
- •11. Fever > 37.8 °C (100°F) measured using the tympanic temperature
- •(or equivalent oral/rectal/axillary temperature) at Day 1.
- •12. Use of immunosuppressive medication, including inhaled (other than
- •Symbicort®), topical, ocular, nasal or rectal corticosteroids and
- •systemic steroids within 28 days before randomization (Day 1)
- •into the study.
- •13. Receipt of immunoglobulin or blood products within 30 days before
- •randomization into the study.
- •14. Receipt of any novel investigational medicinal products within 3
- •months before the first dose of investigational product in this study
- •and through to study end.
- •15. Seropositive for hepatitis B surface antigen, hepatitis C, or human
- •immunodeficiency virus (HIV)-1 or HIV-2).
- •16. Unexplained diarrhea within 30 days prior to screening; or a
- •diagnosis of a helminth parasitic infestation within 6 months prior
- •to screening; history of an untreated systemic helminth parasitic
- •infection; history of living with a person known to have had a
- •helminth parasitic infestation within 12 months prior to screening;
- •history of recent travel to areas where parasite infestations are
- 另有 4 项未显示
研究者
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