Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline in Asthma Control Test
研究概览
简要总结
Develop new real-world evidence indicators of worsening and improving asthma. Scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the number of awakenings per night using Fitbit activity trackers. Scientists will measure asthma symptoms using a once-monthly custom survey delivered to participant smartphones via Twilio. Scientists may measure rescue medication use and adherence to maintenance medications using digital inhaler devices. Scientists will correlate the above measures to participant-reported significant asthma exacerbations (SAEs), lung function (FEV1), and standardized surveys (i.e. the asthma control test (ACT) and global evaluation of treatment effectiveness (GETE)(4)) collected in clinic every 3 months. Coordinators will record any medication changes or reported medication side effects.
Determine response to omalizumab therapy. After participants are placed on omalizumab therapy as part of standard medical care, scientists will determine whether and how real-world evidence can be used to gauge responses to omalizumab. Then, scientists will determine which features, or combination of features, are the best indicators of disease control in the real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months OR an asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent) for at least 1 month prior to enrollment.
- •Participants will need access to a smartphone.
排除标准
- •Active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
- •Conditions that require bursts of oral corticosteroids
- •Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others)
- •Other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.
结局指标
主要结局
Change From Baseline in Asthma Control Test
时间窗: Baseline and Week 52
Standardized asthma symptom survey
次要结局
- Change From Baseline in Steps Per Day(Baseline and Week 52)
- Change From Baseline in Duration of Exercise Per Day(Baseline and Week 52)
- Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication(Baseline and Week 52)
- Change From Baseline in Significant asthma exacerbations (SAEs)(Baseline and Week 52)
- Global evaluation of treatment effectiveness (GETE)(Baseline and Week 52)
- Change From Baseline in Duration of Interrupted Sleep per Night(Baseline and Week 52)
- Change From Baseline in Lung Function(Baseline and Week 52)
- Change From Baseline in Adherence of Inhaled Corticosteroids(Baseline and Week 52)
- Change From Baseline in Intensity of Exercise Per Day(Baseline and Week 52)
- Change From Baseline in Number of Awakenings per Night(Baseline and Week 52)
- Change From Baseline in the Monthly Symptom Questionnaire Scores(Baseline and Week 52)