QUANTAS-PC: Quantifying the Burden of Type 2 (T2) Inflammation in Asthma in Primary Care and Community Specialty Practices
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportion of patients with FeNO ≥ 25 ppb
研究概览
简要总结
This study is designed to support the assessment of Type 2 (T2) biomarkers in asthma in primary care and community specialty practices. To assess T2 biomarkers, individuals will be required to complete a breath test for fractional exhaled nitric oxide (FeNO) and consent to a review of their medical records. Asthma often goes undetected in primary care and community settings, and through this study the researchers hope to optimize referral pathways to care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Inclusion Criteria
- •Age 18 years and older
- •Ability to consent and comply with protocol assessments
- •Pre-existing diagnosis of asthma and has started treatment
- •Participant
排除标准
- •Participant deemed medically ineligible per the opinion of the investigator
- •History of respiratory/lung disease other than asthma (e.g., COPD, emphysema, chronic bronchitis, tuberculosis, cystic fibrosis, lung cancer, recurrent pneumonia or other chronic lung disease)
- •Participants who meet criteria for GINA 5, severe asthma (ICS + additional controllers)
- •Current Enrollment in an asthma intervention trial that could affect asthma outcomes clinically and T2 biomarkers
- •Visit with a specialist (i.e. Pulmonologist or Allergist) in the past year who is measuring FeNO levels
结局指标
主要结局
The proportion of patients with FeNO ≥ 25 ppb
时间窗: Day 1
The proportion of patients with FeNO ≥ 25 ppb will be measured by using a hand-held portable machine at a standard flow rate of 50 mL/s. FeNO levels serve as a biomarker for Type 2 airway inflammation.
次要结局
- Asthma Control Test (ACT) Score(Day 1)
- The proportion of patients with a historical blood eosinophil count ≥ 150 cells/μL(Day 1)
研究者
Monica Kraft
Chair of Medicine
Icahn School of Medicine at Mount Sinai