EUCTR2010-024006-35-GR进行中（未招募）不适用
A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the reduction of Clinical Asthma Exacerbations in Patients (12-75 years of age) with Eosinophilic Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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 are included in the study if all of the following criteria are met:
- •(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
- •(b) The patient has had at least 1 asthma exacerbation requiring oral or iv corticosteroid use for at least 3 days over the past 12 months before screening.
- •(c) The patient has a current blood eosinophil level of at least 400/?L.
- •(d) The patient has airway reversibility of at least 12% to beta-agonist administration.
- •(e) The patient has an ACQ score of at least 1.5.
- •(f) Inclusion criterion (f) is replaced by (f1). The patient is taking inhaled fluticasone at a dosage of at least 440 µg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. Patients’ baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipooxegnase inhibitors, cromolyn) must be stable for 30 days prior to screening, and continue without dosage changes throughout study.
- •(g) All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine).
- •(h) Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- •(i) Written informed consent is obtained. Patients 12 through 17 years old must provide assent.
- •(j) The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation, serum chemistry, hematology, and urinalysis.
- •(k) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients are excluded from participating in this study if 1 or more of the following criteria are met:
- •(a) The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient’s safety.
- •(b) The patient has known hypereosinophilic syndrome.
- •(c) Exclusion criterion (c) is replaced by (c1). The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
- •(d) The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
- •(e) The patient is using systemic immunosuppressive or immunomodulating drugs eg, systemic corticosteroids greater than 10 mg/day daily dose, methotrexate, cyclosporine, antibody 6 months prior to study entry (randomization).
- •(f) The patient has participated in an anti-interleukin-5 (IL-5) study for asthma.
- •(g) The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease).
- •(h) The patient has participated in any investigative drug or device study within 30 days prior to study enrollment (randomization).
- •(i) The patient has participated in any investigative biologics study within 3 months prior to study enrollment (randomization).
- •(j) Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
- •(k) The patient has concurrent infection or disease that may preclude assessment of active asthma.
- •(l) The patient has a history of concurrent immunodeficiency (human immunodeficiency or acquired immunodeficiency syndrome or congenital immunodeficiency).
- •(m) The patient has current suspected drug and alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
- •(n) Presence of or suspected parasitic infestation /infection.
- •(o) Patients may not have received any live attenuated vaccine within the 12-week period prior to screening.
研究者
相似试验
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBERCystic FibrosisFibrosis quísticaMedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lungEUCTR2008-004699-34-ESAstraZeneca AB50
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-group, Multicentre, 24 week Study to Evaluate the Efficacy and Safety of Transdermal Testosterone (300 mcg/day) in Naturally Menopausal Women with Hypoactive Sexual Desire Disorder Receiving Systemic Transdermal Estrogen, Oral Non-Conjugated Equine Estrogen, or No Estrogen Therapy - ADOREHypoactive sexual desire disorderEUCTR2006-001179-39-DEProcter & Gamble Pharmaceuticals270
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)EUCTR2006-001009-27-HUBoehringer Ingelheim Pharma GesmbH3,000
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-centre, Dose Ranging Study to Evaluate the Efficacy and Safety of Losmapimod (GW856553) Tablets Administered Twice Daily compared with Placebo for 24 Weeks in Adult Subjects with Chronic Obstructive Pulmonary Disease (COPD).EUCTR2010-019695-76-EEGlaxoSmithKline Research & Development675
进行中（未招募）
不适用
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre, Long-Term Study to Evaluate the Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 52 Weeks in Adult and Adolescent Subjects with Perennial Allergic RhinitisPerennial allergic rhinitisEUCTR2004-000091-14-LTGlaxoSmithKline736