Systematic Approach for the Diagnosis and Treatment of Obstructive Lung Diseases
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Accuracy of the proposed diagnostic algorithm
研究概览
简要总结
The differential diagnosis of asthma and COPD is sometimes difficult. Recently, an overlap syndrome has been defined based on the concurrence of asthma and COPD characteristics. These characteristics are based on expert opinions and have never been investigated nor validated prospectively.
The investigators assume that the management strategy, the symptom burden and disease progression will differ between asthma, COPD and ACOS. Therefore, the study wants to establish baseline criteria for an appropriate disease definition and evaluate the potential impact on treatment and symptom control.
详细描述
This study aims to test a diagnostic algorithm for obstructive airways diseases that may be used in daily practice to obtain a correct differential diagnosis and, hence, initiate an adequate therapy according to the current guidelines. The proposed algorithm will be used to categorize patients in 4 different diagnoses with specific treatment choices: asthma, obstructive asthma, overlap asthma with COPD, and COPD. The study will evaluate which tests and criteria contribute most to the diagnostic work-up and final diagnosis.
Test battery for diagnosis
- spirometry with bronchodilator reversibility testing
- bodyplethysmography: spirometry, volumes, resistance, diffusing capacity
- exhaled NO
- blood sample
- CT scan of thorax (only when obstructive spirometry)
- histamine challenge (only when spirometry is not obstructive)
- induced sputum (not for protocol interpretation)
Definition of endpoints
- Physician based diagnosis:
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with respiratory symptoms suggestive of chronic airway disease
排除标准
- •Subjects with an immediate need for hospitalization or a treatment of systemic glucocorticoid or long-term antibiotics
- •Subjects with pregnancy
- •Subjects with clinically significant cardiovascular disease that warrants intervention
- •Subject with concomitant pulmonary diseases (pulmonary embolism, interstitial lung disease etc..).
研究组 & 干预措施
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Patients with an obstructive spirometry and characteristics of chronic obstructive pulmonary disease
Clinical intervention:
Long acting B agonist (LABA) + Long acting muscarinic receptor antagonist (LAMA) inhaled therapy
干预措施: LABA + LAMA (Drug)
ASTHMA
patients with asthma and a normal spirometry
Clinical intervention: Inhaled corticosteroids (ICS)
干预措施: ICS (Drug)
ASTHMA COPD OVERLAP SYNDROME
patients with an obstructive spirometry and characteristics of both COPD and Asthma
Clinical Intervention: LABA + LAMA + ICS
干预措施: LABA + LAMA + ICS (Drug)
OBSTRUCTIVE ASTHMA
patients with an obstructive spirometry and characteristics of asthma
Clinical Intervention: LABA + ICS inhaled therapy
干预措施: LABA + ICS (Drug)
OTHER
patients with another diagnosis or healthy persons
clinical Intervention: undefined - according to diagnosis
干预措施: other (Drug)
结局指标
主要结局
Accuracy of the proposed diagnostic algorithm
时间窗: after work-up at inclusion (at baseline)
% changes of algorithm diagnosis compared to physician based diagnosis (based on spirometry only)
Accuracy of the proposed diagnostic algorithm (at one year follow-up)
时间窗: at one year
% changes of algorithm diagnosis compared to final diagnosis (based on all tests with clinical evolution for 1 year))
次要结局
- Difference in ACT/CAT-scores(1 year)
- Difference in Delta ACT/CAT scores (0 - 1 year)(1 year)
- Difference in Delta ACT/CAT scores (0 - 3 months)(3 months)
- specificity and sensitivity of individual criteria for final diagnosis(1 year)
- independency of criteria for final diagnosis(1 year)