EUCTR2010-020127-52-GB进行中（未招募）1 期
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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 101
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
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
- •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 1-year post vasectomy or must use adequate
- •contraception if less than 1 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 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 Investigator or any other relevant cardiovascular disorder as judged by Investigator
- •3. Pregnant, breastfeeding or lactating women
- •4. Known history of allergy/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 past 90 Days prior to
- •7. Other significant pulmonary disease as a primary diagnosis if a subject is diagnosed with any other pulmonary diseases as a secondary diagnosis they may be included if, in the opinion of the investigator/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 min. of 15 hrs per day
- •9. Subjects who have 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 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 wks before sputum collection at screening (Day -56)
- •11. Fever >37.8 °C (>100°F) measured using the tympanic temperature (or equiv. oral/rectal/axillary temperature) at Day 1
- •12. Use of immunosuppressive medication, including inhaled (other than Symbicort®),
- •topical, ocular, nasal or rectal corticosteroids & 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 diagnosis of helminth parasitic infestation within 6 months prior to screening; history of untreated systemic helminth parasitic infection; history of living with 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 endemic within 3 months before screening
- •17. Any subjects that have positive serum serology during screening/run-in period to Strongyloides stercoralis will be excluded. Subjects with positive serology to Schistosoma mansoni, Taenia solium, or Ascaris lumbricoides will undergo a confirmatory stool sampling per local guidelines1. If stool sampling is positive for Schistosoma mansoni or Taenia solium the subject will be excluded. All s
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