NCT01922037已完成4 期
A Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 806
- 试验地点
- 143
- 主要终点
- Total Number of Asthma Exacerbations During Months 1-12
研究概览
简要总结
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants identified by the investigator as a candidate for treatment for asthma with omalizumab
- •Confirmation of access to omalizumab through insurance or other source of funding
排除标准
- •Enrollment in any other concurrent clinical trial or observational study
- •Participants for whom omalizumab treatment is contraindicated
- •Participants who had a prior allergic reaction to omalizumab or its excipients
- •Participants treated with omalizumab within the previous year
- •Participants who received an experimental drug as part of another study within 3 months of enrollment
研究组 & 干预措施
Participants With Allergic Asthma
Experimental
Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.
干预措施: Omalizumab (Drug)
结局指标
主要结局
Total Number of Asthma Exacerbations During Months 1-12
时间窗: Months 1-12
An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for \>/= 3 days.
次要结局
- Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6(Months 1-6)
- Total Number of Asthma-Related ER Visits During Months 7-12(Months 7-12)
- Total Number of Asthma Exacerbations During Months 1-6(Months 1-6)
- Total Number of Asthma-Related ER Visits During Months 1-12(Months 1-12)
- Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12(Months 1-12)
- Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6(Months 1-6)
- Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12(Months 7-12)
- Percentage of Participants by Number of Asthma Exacerbations(Months 1-12)
- Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids(Months 1-12)
- Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)(Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12))
- Total Number of Asthma Exacerbations During Months 7-12(Months 7-12)
- Total Number of Asthma-Related Hospital Admissions During Months 7-12(Months 7-12)
- Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12(Months 1-12)
- Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6(Months 1-6)
- Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12(Months 7-12)
- Total Number of Asthma-Related Hospital Admissions During Months 1-12(Months 1-12)
- Total Number of Asthma-Related Hospital Admissions During Months 1-6(Months 1-6)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score(Baseline, Month 6, EOS/ET (up to Month 12))
- Change From Baseline in Raw Forced Vital Capacity (FVC)(Baseline, Month 6, EOS/ET (up to Month 12))
- Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%-75%)(Baseline, Month 6, EOS/ET (up to Month 12))
- Change From Baseline in Percentage Predicted FEV1 (ppFEV1)(Baseline, Month 6, EOS/ET (up to Month 12))
- Percentage of Participants With Prior Asthma Medications by Category or Class of Medications(Baseline)
- Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications(Baseline until EOS/ET (up to Month 12))
- Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score(Baseline, Month 6, EOS/ET (up to Month 12))
- Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score(Baseline, EOS/ET (up to Month 12))
- Change From Baseline in Asthma Control Test (ACT) Overall Score(Baseline, Months 3, 6, 9, 12)
- Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator(EOS/ET (up to Month 12))
- Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant(EOS/ET (up to Month 12))
研究者
研究点 (143)
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