EUCTR2015-003533-10-Outside-EU/EEA进行中（未招募）不适用
A Randomized, Open-label, Multicenter Study to Evaluate the Effect of Xolair (Omalizumab) as Add-on Therapy to Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing Compared to Isolated Inhaled Corticosteroid + Long-Acting Beta Agonist in Fixed or Flexible Dosing in the Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ovartis
- 入组人数
- 123
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
- •12 to 75 years-old during screening visit.
- •Body weight > 20 kg and < 150 kg.
- •Daily or persistent asthma symptoms.
- •Night symptoms at least once a week.
- •Forced expiratory volume in 1 second (FEV1) > 40% and < 80% of
- •predicted normal value and continuing asthma symptoms.
- •FEV1 increased > 12% from baseline within 30 minutes of inhaled (up
- •to 400 mcg) or nebulized (up to 5 mg) salbutamol.
- •Subject taking more than 500 mcg/day of fluticasone or equivalent
- •associated to a long-acting ß2-agonist.
- •Inhaled corticosteroid and long-acting beta-2 adrenergic agonist
- •(LABA) doses that remained fixed during the last 12 weeks prior to
- •Medical history of at least two episodes of asthma exacerbation
- •treated with systemic corticoid or at least one severe asthma
- •exacerbation treated with systemic corticoid and hospitalization or
- •emergency room visit in the last 12 months prior to screening.
- •Positive skin prick test (diameter of wheal > 3mm) to at least one
- •perennial aeroallergen (dust mite, cat/dog dander, cockroaches), to
- •which the subject was likely to be exposed during the study.
- •Subject capable to read and understand asthma related quality of life
- •questionnaire (Juniper's questionnaire).
- •Other protocol-defined inclusion criteria applied to the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Pregnant, nursing female subjects.
- •Female subjects without current acceptable contraceptive method.
- •Previous history of allergy or hypersensitivity to omalizumab.
- •Subjects with prior treatment with omalizumab.
- •Subjects with medical history of psychiatric disorder.
- •Subject had been treated with systemic corticosteroid for any reason
- •other than asthma.
- •Subject took ß2 antagonist medication in the last 3 months prior to
- •screening visit.
- •Subject took protocol prohibited medication prior to screening.
- •Medical history of food or drug related severe anaphylactoid
- •Medical history of antibiotics allergy. Patients were included if the
- •antibiotics to which they were allergic to were to be avoided for the
- •entire duration of the study.
- •Asthma related to non-steroidal anti-inflammatory drug (NSAID).
- •Treatment of exacerbation in the 4 weeks prior to randomization.
- •Other active lung diseases.
- •Medical history of others uncontrolled diseases 3 months prior
- •randomization (eg, infections, coronary heart diseases and metabolic
- •Any history of cancer.
- •Abnormal electrocardiogram (ECG), laboratory exams (clinically
- •significant abnormalities), and chest X-ray (CXR).
- •Evidence or history of drug or alcohol abuse.
- •Airway infection (eg, pneumonia, acute sinusitis) 4 weeks prior to
- •screening visit.
- •Smokers or smoking history of > 10 pack-years.
- •Subject that had been treated with investigational drugs over the past
- •30 days or during the course of the trial.
- •Subject had elevated IgE levels for reasons other than allergy.
- •Other protocol-defined exclusion criteria applied to the study.
研究者
相似试验
进行中（未招募）
不适用
A research study of a new medicine, danoprevir, with ritonavir and Copegus (also known as ribavirin), in combination with another new medicine, RO5024048, and/or Pegasys for the treatment of a disease called chronic hepatitis C, which causes damage to the liver, in patients that failed a previous treatment for hepatitis C.Chronic Hepatitis CMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-019585-90-DEF.Hoffmann-La Roche381
进行中（未招募）
1 期
A research study of a new medicine, danoprevir, with ritonavir andCopegus (also known as ribavirin), in combination with another newmedicine, RO5024048, and/or Pegasys for the treatment of a diseasecalled chronic hepatitis C, which causes damage to the liver, in patientsthat failed a previous treatment for hepatitis C.Chronic Hepatitis CMedDRA version: 14.0Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-019585-90-ESF.Hoffmann-La Roche420
进行中（未招募）
不适用
A Randomized, Open-label, Multicenter Study to Evaluate the Sustained Virologic Response of the HCVProtease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (Danoprevir/r) and Copegus, inCombination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys in ChronicHepatitis C Genotype 1 Patients Who Failed with a Previous Course of Peginterferon alfa plus RibavirinCombination Therapy - MatterhorEUCTR2010-019585-90-ITF.Hoffmann-La Roche420
进行中（未招募）
不适用
A research study of a new medicine, danoprevir, with ritonavir and Copegus (also known as ribavirin), in combination with another new medicine, RO5024048, and/or Pegasys for the treatment of a disease called chronic hepatitis C, which causes damage to the liver, in patients that failed a previous treatment for hepatitis C.EUCTR2010-019585-90-ATF.Hoffmann-La Roche420
进行中（未招募）
1 期
A research study of a new medicine, danoprevir, with ritonavir and Copegus (also known as ribavirin), in combination with another new medicine, RO5024048 and/or Pegasys for the treatment of a disease called chronic hepatitis C, whch causes damge to the liver, in patients that failed a previous treatment for hepatitis C.EUCTR2010-019585-90-GBF.Hoffmann-La Roche420