Inner-City Anti-IgE Therapy for Asthma (ICAC-08)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 419
- 试验地点
- 15
- 主要终点
- Maximum Number of Asthma Symptom Days
研究概览
简要总结
The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone, in inner-city children with mild to severe asthma.
详细描述
This study is testing a medication called omalizumab for the treatment of asthma. Immunoglobulin E (IgE) is produced when one is exposed to allergens and it can cause inflammation in the lungs. Omalizumab can reduce inflammation and asthma attacks by blocking IgE. Unlike other medications for asthma, omalizumab is not an inhaler medication or pill. Instead, omalizumab is dissolved in a liquid and given by injection.
Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas. The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer, more effective, and longer lasting asthma treatment strategy than standard treatment alone.
This study will recruit inner-city children and adolescents with moderate to severe allergic asthma. This study will last about 1.5 to 2 years. Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks. The injection schedule will be determined based on the participant's weight and total IgE. Both groups will receive standardized specialist care and basic asthma education including environmental control measures. Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study.
Participants will complete a series of questionnaires about topics including perceived stress, home environment, physical activity, diet and nutrition, smoking habits, and quality of life. At study entry and monthly throughout the study, participants will complete questionnaires about their asthma symptoms and medical resource utilization. Some visits will include a physical examination, vital signs measurement, lung function tests, asthma medication evaluation, and an asthma action plan. Blood collection is required up to eight times during the study for safety labs.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both body weight and total serum IgE suitable for omalizumab dosing.
- •Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
- •Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
- •Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
- •Live in a preselected zip code are
- •Able to perform spirometry measurements
- •Willing to sign informed consent or have parent or guardian willing to provide informed consent
- •Previously had chicken pox or received varicella (chicken pox) vaccine
- •Have some form of health care insurance that covers costs of medications
排除标准
- •If participant meets any of these criteria, they are not eligible at that time but may be reassessed:
- •Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
- •Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
- •Pregnancy or breastfeeding
- •Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
- •Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
- •Does not sleep at least 4 nights per week in one home
- •Lives with a foster parent
- •Does not have access to a phone
- •Plans to move during the study
- •Previously treated with anti-IgE therapy within 1 year of study entry
- •Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
- •Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry
- •If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:
- •Significant medical illness. More information on this criterion can be found in the protocol.
- •Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
- •Known hypersensitivity to any ingredients of omalizumab or related drugs
- •Diagnosis of cancer, being investigated for possible cancer, or history of cancer
- •Will not allow study physician to manage their asthma
- •Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
- •History of severe anaphylactoid or anaphylactic reaction(s)
结局指标
主要结局
Maximum Number of Asthma Symptom Days
时间窗: Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.
Maximum symptom days was calculated as the largest of the following variables: number of days with wheezing, chest tightness, or cough; number of nights of sleep disturbance; and number of days when activities were affected. This symptom scale ranges from 0 to 14 days per a 2-week look-back period. A higher score reflected a greater number of asthma symptoms. Data represent an average of those collected in the time period (weeks 12-60), where at least one value was available in this assessment period and at baseline for a participant.
次要结局
- Economic Outcome: Comparison of Number of Missed School Days Due to Asthma(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Child Asthma Control Test (C-ACT) Score(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of treatment.)
- FEV1/FVC Ratio(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Dose Inhaled Corticosteroids (Glucocorticoids)(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Percent Prevalence: Prescribed Rescue Beta 2 Agonists(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Asthma Control Test (ACT) Score(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Economic Outcome: Number of Missed Work Days by Caretaker Due to Asthma(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Forced Expiratory Volume in 1 Second (FEV1) % Predicted(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Percent Adherence to Asthma Medication(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment)
- Percent Prevalence: Treatment Step Level 4 Through 6 (Severe Asthma)(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment)
- Percent Prevalence: Asthma Exacerbations(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Exhaled Nitric Oxide(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Paediatric Asthma Quality of Life Questionnaire (PAQLQ) Overall Score(Week 60)
- Percent Prevalence: Treatment Step Level 1 or 2 (Mild Asthma)(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment)
- Percent Prevalence: Asthma-Related Medical Care Resource Utilization - Hospitalizations(Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
- Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) Overall Score(Week 60)