NCT02123667已完成不适用
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS); Multinational, Multicentre, Non-pharmacological Intervention, Cross-sectional and Longitudinal Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 872
- 试验地点
- 44
- 主要终点
- To determine the role of small airways abnormalities in the clinical manifestations of asthma.
研究概览
简要总结
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
详细描述
Large non pharmacological studies on Small Airways Disease
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asthmatic patient inclusion criteria
- •Male or female patients aged ≥ 18 and ≤ 65 years, who have signed an Informed Consent form
- •Clinical diagnosis of asthma f
- •Positive response to methacholine challenge test
- •Positive response to a reversibility test or
- •Peak Flow variability (i.e. highest - lowest PEF over the day/mean value of the two, × 100) > 20% or
- •Documented response (defined as ΔFEV1 ≥ 12% and ≥ 200 mL) after a cycle (e.g., 4 weeks) of regular maintenance anti-asthma treatment.
- •Patients with stable asthma.
- •Current smoker, ex-smoker or lifelong non-smoker Healthy subject inclusion criteria
- •1. Male or female patients aged ≥ 18 and ≤ 65 years
- •No clinical history of asthma or COPD
- •Current smoker, ex-smoker or lifelong non-smokers
- •Normal spirometry
- •Normal airways responsiveness Asthmatic patient
排除标准
- •Cigarette smoking > 10 packyears
- •diagnosis of COPD
- •Asthma exacerbation in the 8 weeks prior to baseline visit
- •Clinical or functional uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that might compromise the results or interpretation of the study.
- •Pregnant or lactating women
- •Participation in an interventional clinical trial <12 weeks preceding baseline visit
- •Inability to comply with study procedures.
- •Alcohol or drug abuse. Healthy subject exclusion criteria
- •1. Cigarette smoking history > 10 packyears
- •Diagnosed upper and/or lower respiratory disease(s).
- •Clinical or functional uncontrolled haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that mightp compromise the results or interpretation of the study.
- •4. Pregnant or lactating women
- •Participation in an interventional clinical trial <12 weeks preceding baseline visit
- •Inability to comply with study procedures.
- •Alcohol or drug abuse.
研究组 & 干预措施
Asthmatic patients
asthmatic patients 18 to 65
Healthy volunteers
Volunteers 18 to 65
结局指标
主要结局
To determine the role of small airways abnormalities in the clinical manifestations of asthma.
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (44)
Loading locations...
相似试验
已完成
不适用
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)small airways abnormalities10038716asthmaNL-OMON41215Chiesi Farmaceutici S.p.A.104
已完成
不适用
Prospective evAluatIon foR Inhalation Devices StudyCOPDAsthmaNCT01800994Elpen Pharmaceutical Co. Inc.750
招募中
1 期
A study to assess the effect allergic rhinitis in a non asthmatic individual on the lung functionsCTRI/2019/01/016940il
Unknown
不适用
Effects of Multidisciplinary Interventions in Elderly Asthma Patients With Risk of Acute ExacerbationAgedAsthmaNCT01843439Sang-Heon Cho360
已完成
4 期
GSK BHR Study (Sont - Second Study)AsthmaNCT01324362GlaxoSmithKline446