PER-077-13未知未知
A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE 3 EFFICACY AND SAFETY STUDY OF BENRALIZUMAB (MEDI-563) ADDED TO MEDIUM-DOSE INHALED CORTICOSTEROID PLUS LONG-ACTING β2 AGONIST IN PATIENTS WITH UNCONTROLLED ASTHMA (PAMPERO)
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2014年1月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •3.1Inclusion criteria
- •For inclusion in the study patients must fulfil all of the following criteria:
- •1.Provision of informed consent prior to any study specific procedures
- •2.Female and male aged from 18 to 75 years, inclusively
- •3.Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the Investigator). Highly effective forms of birth control includes: true sexual abstinence, a vasectomised sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD Intrauterine device/IUS Ievonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™. WOCBP must agree to use highly effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks after last dose of IP, and have negative serum pregnancy test result on Visit 1.
- •Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postemenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:
- •Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle stimulating hormone (FSH) levels in the postmenopausal range
- •Women ≥50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment
- •4.All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose
- •5.Weight of ≥40 kg
- •6.History of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1. Equivalents for fluticasone dry powder can be found in Appendix E
- •7.Documented treatment with medium-dose ICS (>250μg and <500μg fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 months prior to Visit 1. Equivalents for fluticasone dry powder can be found in Appendix E
- •8.Additional maintenance asthma controller medications (eg, LTRAs, tiotropium, cromone, theophylline and oral corticosteroid), that have been stable for at least 30 days prior to Visit 1, are allowed. Five- lipoxygenase inhibitors (eg, Zileuton) are prohibited
- •9.Morning pre-bronchodilator (Pre-BD) FEV1 of <80% predicted at Visit 2 (Week -5)
- •10.At least 2 documented asthma exacerbations in the 12 months prior to the date informed consent is obtained that required use of a systemic corticosteroid or temporary increase from a stable maintenance dose of oral corticosteroid (please refer to Section 4.1.1)
- •11.ACQ-6 score ≥ 1.5 at Visit 1 (Week - 6) and Visit 3 (Week - 1)
- •12.Documented post-bronchodilator (post-BD) reversibility in FEV1 of >12% and >200 mL in FEV1 within 12 months prior to planned date of randomization
- •13.A peripheral blood eosinophil count ≥300/µl during screening (Visit 3, Week -1)
排除标准
- •3.2Exclusion criteria
- •Patients must not enter the study if any of the following exclusion criteria are fulfilled:
- •1.Clinically important pulmonary disease other than asthma (eg, active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (eg, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- •2.Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- •Affect the safety of the patient throughout the study
- •Influence the findings of the studies or their interpretations
- •Impede the patient’s ability to complete the entire duration of study
- •3.Known history of allergy or reaction to the investigational product formulation
- •4.History of anaphylaxis to any biologic therapy
- •5.A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy
- •6.Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
- •7.Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete entire duration of the study
- •8.Any clinically significant cardiac disease or any ECG abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments
- •9.History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained
- •10.Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
- •11.A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test
- •12.Current smokers or former smokers with a smoking history of > 10 pack-years
- •13.History of cancer:
- •Patients who have had basal cell carcinoma, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained
- •Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
- •14.Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-a
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