EUCTR2015-001868-19-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, mono-center study to evaluate the effects of mepolizumab on airway physiology in patients with eosinophilic asthma: the MEMORY study - MEMORY
niversity medical center of Johannes Gutenberg University Mainz0 个研究点开始时间: 2015年7月6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
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
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •1. Patients must be able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form.
- •2. Male or female patients at least 18 years of age at date of informed consent
- •3. Females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control. Female patients must be postmenopausal (for at least 12 months without an alternative medical cause), surgically sterile, or if sexually active, be practicing an effective method of birth control throughout the study. Reliable highly effective contraceptions with low failure rate are systemic contraceptives (oral, implants, injection), intrauterine device (IUD) and intrauterine hormone-releasing system (IUS).
- •A urine pregnancy test is required of all female patients. This test will be performed at the initial screening visit (visit 1). In addition, a urine pregnancy test will be performed prior to randomization and at each scheduled study visit prior to the injection of the investigational product and at the follow-up visit.
- •4.Physician-diagnosis of asthma and evidence of asthma as documented by reversibility of airflow obstruction (FEV1 12% or 200 ml) demonstrated at visit 1 or visit 2 or documented in the previous 24 month.
- •5. Inhaled corticosteroid (ICS) dose must be = 1000 µg/day beclomethasone (BDP) or equivalent daily with or without maintenance oral corticosteroids.
- •6. Treatment in the past 12 months with an additional controller medication for at least 3 successive months, e.g., long-acting beta-2-agonist (LABA), leukotriene receptor antagonist (LTRA), or theophylline.
- •7. Persistent airflow obstruction as indicated by a pre-bronchodilator FEV1 < 80% predicted recorded at Visit 1 or < 90% for patients on oral corticosteroids.
- •8. An elevated peripheral blood eosinophil level of ? 300/?L that is related to asthma or 150/L in patients treated with oral corticosteroids as maintenance therapy demonstrated at visit 1 or in the previous 12 months
- •9. Confirmed history of two or more exacerbations requiring treatment with systemic corticosteroids (intramuscular, intravenous, or oral), in the 12 months prior to visit 1, despite the use of high-dose inhaled corticosteroids. For patients receiving maintenance corticosteroids, the corticosteroid treatment for the exacerbations must have been a two-fold increase or greater in the dose.
- •10. Patients must be able to read, comprehend, and write at a level sufficient to complete study related materials
- •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 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Patients presenting with any of the following criteria will not be included in the trial:
- •1. Current smokers or former smokers with a smoking history of 10 pack years (number of pack years = (number of cigarettes per day / 20) x number of years smoked). Patients who have not smoked for = 6 months before visit 1 and have < 10 pack years can be included into the study.
- •2. Presence of a clinically important lung condition other than asthma. This includes current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or diagnoses of emphysema or chronic bronchitis (chronic obstructive pulmonary disease other than asthma) or a history of lung cancer. Patients who experience an infection or exacerbation between screening and randomization can be re-screened four weeks after recovery of the infection or exacerbation with keeping it´s original screening number. The data of the re-screening visit should be documented in the eCRF.
- •3. Evidence of clinically significant abnormality in the haematological (except eosinophil level), biochemical or urinalysis screen at Visit 1, as judged by the investigator. Abnormalities based on known underlying diseases are not excluded.
- •4. Evidence of significant abnormality in the 12 lead ECG at Visit 1.
- •5. A current malignancy or previous history of cancer in remission for less than five years prior to screening (Patients that had localized carcinoma of the skin which was resected for cure will not be excluded).
- •6. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- •7. Patients who have received omalizumab [Xolair] within 130 days of Visit 1.
- •8. Patients who have received any biological to treat inflammatory disease within 5 half-lives of visit 1
- •9. Patients who have received methotrexate, troleandomycin, cyclosporin, azathioprine within 90 days of visit 1
- •10. Patients with allergy/intolerance to the excipients in the mepolizumab formulation.
- •11. Ongoing participation in other clinical trials or within the past 30 days or five terminal phase half-lives of the drug whichever is longer, prior to visit 1 (this also includes investigational formulations of marketed products).
- •12. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation.
- •13. Patients who have clinically significant cardiovascular, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
- •14. A history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
- •15. A parasitic infestation within 6 months prior to Visit 1.
- •16. Patients who are not able or willing to comply with the provisions of controller medication and/or to follow trial physician’s recommendations.
- •17. Patients, who are legally institutionalized.
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