REGAIN: Real World and Genomic Data Based Asthma Insight Through Network Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,075
- 试验地点
- 10
- 主要终点
- Asthma disease subtypes
研究概览
简要总结
A retrospective and prospective observational study of asthma designed to determine real-world and molecular description of asthma according to treatment and type 2 biology
详细描述
REGAIN is a retrospective and prospective asthma cohort study designed to determine real-world molecular description of asthma according to treatment and type 2 biology. The researchers will enroll 5 pre-specified groups of participants with asthma of specific interest for mechanistic analyses according to clinically determined type 2 inflammatory endotype and response to therapy with inhaled steroids and other inhaled controllers with or without asthma biologics. This study is conducted at asthma specialty programs at Mount Sinai National Jewish Health Respiratory Institute in New York and National Jewish Health, Denver, Colorado, USA. Participants with asthma meeting specific inclusion criteria were identified and enrolled by screening electronic medical records from pulmonary and allergy specialty programs. Targeted populations included 5 categories of asthma patients as outlined in Table 1 including the following: (1) patients with type 2 asthma with symptom control at time of enrollment (ACT > 20) on standard Global Initiative For Asthma (GINA) step therapy (n=200) (2) asthma managed on stable biological therapy (n=200), (3) type 2 asthma with prior treatment with at least 2 biological therapies, (n=60), (4) likely type 2 low asthma patients (n=200), (5) asthma patients scheduled to be started de novo on biological therapies (n=120), and (6) healthy participants (n=400). Healthy participants were recruited in New York and Denver by community advertising. An optional study component employing a mobile phone application, use of digital inhaler monitors, and home digital peak flow will contribute data regarding medication use and lung function in the community and collect environmental data impacting asthma using geolocation data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Asthma Participants:
- •Clinical diagnosis of asthma verified by a specialist physician (allergist or pulmonologist) and one or more of the following:
- •Historical variability of airflow limitation via classic reversibility criteria (> 12%, 200 ml within past 10 years).
- •Historical methacholine challenge with PC20 < 8 mg/ml (within past 10 years).
- •FEV1 variability, between two clinic visits, of 20% within the past 5 years either with improvement according to appropriate therapy or decrease in lung function upon withdrawal or decrease of therapy.
- •Elevated FeNO > 50 ppb at least once historically (within past 10 years).
- •< 10 pack per year personal tobacco use and not a current smoker of cigarettes or other inhalational tobacco (e-cigarette, marijuana or other inhalational drug use).
- •At least partial response of presenting symptoms to GINA Step 1-4 asthma treatment (ICS or ICS/LABA as determined by study physician investigators)
排除标准
- •for Asthma Participants:
- •>10 pack per year tobacco, current smoker of cigarettes, e-cigarettes or other inhalational drug use.
- •Clinically significant lung disease based on imaging or clinical history other than asthma as determined by an allergist or pulmonologist
- •Currently pregnant or breastfeeding
- •Anemia with hemoglobin level ˂9 mg/dl at the time of study enrollment
- •Inclusion Criteria for Healthy Controls:
- •Age > 18
- •No current smoking (quit > 6 months previously) confirmed by serum cotinine level < 1 ng/ml
- •< 10 pack year tobacco history
- •No current respiratory symptoms (cough wheeze, dyspnea)
- •No current lung disease or other significant medical comorbidity (see exclusion criteria below)
- •Exclusion Criteria for Healthy Controls:
- •Age < 18
- •Diagnosis of asthma, COPD, emphysema, bronchiectasis or other significant lung disease
- •Treatment or a history of malignancy currently or within the past 5 years, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
- •Treatment of inflammatory disease or autoimmune disease such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis or others
- •Treatment with immune modulating medications for a health condition including any of the following (systemic glucocorticoids, sirolimus, tacrolimus, anti-TNF abatacept, azathioprine, methotrexate, cyclosporine, cyclophosphamide, immunoglobulin, mycophenolate, rituximab, plaquenil or others)
- •Treatment with anti-IL5, anti-IgE and anti-IL4 receptor alpha for non-asthma indications
- •Vaccination within 4 weeks
- •History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, gastrointestinal, uncontrolled diabetes, uncontrolled infectious disease, HIV infection, cerebrovascular, or other significant medical illness or disorder which in the judgment of the investigator could impact the participant as a healthy control
- •Serum cotinine > 1 ng/ml
结局指标
主要结局
Asthma disease subtypes
时间窗: 18 months
Description of asthma disease subtypes according to type 2 and non-type 2 biology and control or lack of control along a range of asthma treatments.
次要结局
- Number of responders versus non-responders(6 and 18 months)
- Symptom status(6 and 18 months)
研究者
Linda Rogers
Associate Professor
Icahn School of Medicine at Mount Sinai