Bronchodilator Response in COPD and Asthma: Correlation Between Spirometry, IOS Indices, and Dyspnea Relief
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- FEV1
研究概览
简要总结
A bronchodilator reversibility test is widely used in the diagnosis and management of obstructive lung diseases.
Bronchodilators relieve symptoms in asthma and COPD. Traditionally, their effectiveness has been assessed using spirometric indices, particularly FEV₁. However, changes in FEV₁ often do not correlate well with patients' subjective experience of dyspnoea relief or with changes in small airway function.
Impulse oscillometry (IOS) provides an effort-independent assessment of respiratory mechanics during tidal breathing and is more sensitive to small airway dysfunction than spirometry. Despite this, the clinical utility of IOS in routine COPD and asthma assessment remains underexplored, and its relationship to both spirometric response and symptom relief is not fully established, and the Minimal Clinically Important Difference (MCID) for IOS parameters has not been firmly established. Determining the MCID is essential for interpreting individual patient responses in a clinically meaningful way and for guiding treatment decisions in both research and practice.
Hypothesis & Aims
In patients with either asthma or COPD baseline values and bronchodilator responses are compared. More specifically, this study aims to:
- assess baseline correlations: Evaluate the correlation between ΔX5-baseline (EFL expiratory flow limitation=small airway collapse during expiration), RV/TLC-baseline, X5-average at baseline, FEV1-baseline, VAS-dyspnea at baseline, and ACQ-6-baseline.
- compare bronchodilator responses across methods: Examine the correlation between bronchodilator-induced changes in FEV₁ and IOS parameters (including both average and delta values) and explore their relationship with short-term changes in dyspnea.
- establish clinical relevance: Determine the MCID for key IOS variables using both anchor-based and distribution-based approaches, anchored to perceived changes in lung symptoms.
详细描述
Introduction and aims: see brief summary.
Method and Patients This is a real-life, cross-sectional analysis of a single-centered, observational study on 60 adult patients with clinical diagnosed asthma and 60 COPD patients, consecutively recruited between February 1, 2026, and June 30, 2027, and followed at least 6 months for diagnostic clarification.
Inclusion Criteria:
Both asthma and COPD patients:
- Written informed consent.
- FEV1/Forced Vital Capacity (FVC) <0.7 at baseline )
- Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both asthma and COPD patients:
- •Written informed consent.
- •FEV1/Forced Vital Capacity (FVC) <0.7 at baseline (7)
- •Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26).
- •Asthma: Doctor diagnosed asthma
- •1. less than 10 packyears.
- •COPD: Doctor diagnosed COPD with FEV1/FVC <0.7 post-bronchodilation
- •Smokers or ex-smokers with ≥10 packyears
排除标准
- •Patients aged less than 18 years old.
- •Not able to perform spirometry or impulse oscillometry.
- •Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28).
- •Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days.
- •Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease
- •BMI ≥40 kg/m2.
研究组 & 干预措施
Asthma
FEV1/Forced Vital Capacity (FVC) <0.7 at baseline (7) Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26). Doctor diagnosed asthma Less than 10 packyears.
Exclusion Criteria:
- Patients aged less than 18 years old.
- Not able to perform spirometry or impulse oscillometry.
- Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28).
- Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days.
- Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease
- BMI ≥40 kg/m2.
干预措施: Bronchodilator (Diagnostic Test)
COPD
FEV1/Forced Vital Capacity (FVC) <0.7 at baseline (7) Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26).
Doctor diagnosed COPD Smokers or ex-smokers with ≥10 packyears
Exclusion Criteria:
- Patients aged less than 18 years old.
- Not able to perform spirometry or impulse oscillometry.
- Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28).
- Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days.
- Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease
- BMI ≥40 kg/m2.
干预措施: Bronchodilator (Diagnostic Test)
结局指标
主要结局
FEV1
时间窗: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Forced expiratory volumen in one second, L and % predicted
X5
时间窗: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Reactance at 5 Hz; kPa/L/s
Dyspnoea
时间窗: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Visual analog scale (0-100); 0 means no dyspnoea, and 100 means maximum dyspnoea
次要结局
- R5(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- R5-R20(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- Fres(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- AX(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- Delta-X5(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- Delta R5(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- FEF 25-75(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)
- FEV1/FVC-ratio(Before and 20 minuttes after inhaled Salbutamol 0.4 mg)