A Randomized, Open Label, Parallel-group, International, Multicenter Study Evaluating Persistency of Response to Omalizumab During 32 Weeks Treatment Given as Add on to Optimized Asthma Therapy in Adult and Adolescent Patients With Severe Persistent Allergic Asthma, Who Remain Inadequately Controlled Despite GINA (2004) Step 4 Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 406
- 主要终点
- Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
研究概览
简要总结
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met the following criteria were included:
- •Males or females of any race, who were 12-75 years of age
- •A body weight ≥ 20 kg and ≤ 150 kg and with a total serum IgE level ≥ 30 to ≤ 700 IU/ml
- •A diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria and at screening a history consistent with GINA (2204) step 3 or 4 clinical features
- •A positive prick skin test (diameter of wheal >= 3 mm) to at least one perennial allergen documented within the past 2 years or taken at visit 1
- •Increase in FEV1 ≥12% over baseline value within 30 minutes of taking 2 to 4 puffs (2-4x100µg) salbutamol (albuterol) or nebulized salbutamol up to 5mg
- •An FEV1 ≥ 40 and ≤ 80% of the predicted normal value for the patient at randomization
- •Receiving moderate to high dose inhaled corticosteroid ≥ 800 µg BDP or equivalent and a regular inhaled long acting B-2 agonists for at least 3 months prior to screening and > 1000 µg (BDP) and a LABA for at least 4 weeks during the run-in and at randomization
- •Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations while receiving high doses of ICS (≥ 800 µg BDP or equivalent) plus regular inhaled LABA
- •Evidence of poor asthma control at screening (based on patient history) and for at least 4 weeks immediately prior to randomisation
排除标准
- •Patients who met the following criteria were excluded:
- •Had received systemic corticosteroids for reasons other than asthma within 4 weeks of Visit 1
- •A smoking history >10 pack years
- •An active lung disease other than allergic asthma
- •Elevated serum IgE levels for reasons other than allergy
- •Patients with significant underlying medical conditions
研究组 & 干预措施
OAT + Omalizumab
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
干预措施: Omalizumab (Drug)
OAT + Omalizumab
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
干预措施: Optimized asthma therapy (Other)
Optimized Asthma Treatment (OAT)
During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.
干预措施: Optimized asthma therapy (Other)
结局指标
主要结局
Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE)
时间窗: Weeks 16 and 32
Persistency of response, based on GETE, was dichotomized into responders (excellent or good) and non-responders (moderate, poor or worsening). Persistent responders were patients who were responders at 16 weeks and still at 32 weeks. Persistent non-responders were patients who were non-responders at 16 weeks and still at 32 weeks. Patients were assessed for persistency of response if they were responders at Week 16 and had a second GETE obtained ≥ 4 weeks after the Week 16 assessment or discontinued prematurely for unsatisfactory therapeutic effect ≥ 4 weeks after the Week 16 assessment.
次要结局
- Number of Participants by Patient's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and 32(Weeks 16 and 32)
- Number of Participants by Investigator's Global Evaluation of Treatment Effectiveness (GETE) Category at Week 16 and Week 32(Weeks 16 and 32)
- Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Patient's GETE(Weeks 16 and 32)
- Number Participants With Clinically Significant Asthma Exacerbations by Category During the 32 Week Treatment Period(32 Weeks)
- Percentage of Participants Who Were Responders at Both Week 16 and Week 32 Based on Investigator's GETE(Weeks 16 and 32)
- Change From Baseline in Asthma Control Questionnaire (ACQ) Overall Score at Weeks 16 and 32(Baseline, Week 16, Week 32)
- Percent Change in Dose of Maintenance Systemic Steroids at Weeks 16 and 32(Weeks 16 and 32)
- Number of Participants by Type of Dose Change of Maintenance Systemic Steroids at Weeks 16 and 32(Weeks 16 and 32)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score by Visit(Baseline, Week 15, Week 31)
- Lung Function Assessed by Forced Expiratory Volume for 1 Second (FEV1)(Weeks 16 and 32)
- Medical Resource Utilization: Number of Participants With Combined Hospital Admissions, Emergency Room Visits, and Other Outpatient Clinical Visits Due to an Asthma Exacerbation During the 32 Week Treatment Period(32 Weeks)
- Change From Baseline in EuroQual 5-Dimension Health Status Questionnaire (EQ-5D) Index Score and Health State Assessment on Scale From 0 to 100 at Weeks 15 and 31(Baseline, Week 15, Week 31)
- Changes From Baseline to Week 31 in the Percent Overall Work Impairment Due to Asthma Problems(Baseline and Week 31)