Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle
研究概览
简要总结
- Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is caused by inflammation of peripheral airways walls.
- Neutrophils and other inflammatory mediators Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO) are implicated in the inflammation.
- Exhaled NO concentration is usually used to monitor bronchial inflammation
- The relationship between decubitus and small airways behaviour is not well understood.
- Our hypothesis is that cyclic opening and closure of peripheral airways during decubitus can provoke an inflammatory response which can be monitored by exhaled NO.
- Data about these physiopathological aspects is missing in literature.
详细描述
Bronchial inflammation in COPD represents one of the main causes of not fully reversible obstruction and airflow limitation. The main inflammatory cells involved are represented by the neutrophils, while some inflammatory mediators (IL6, IL8, IL1alpha, IL1beta, TNFalfa, ROS, LTB4, NO) provoke the disruption of the elastic alveolar bonds that support the small airways, thus invalidating their physical and mechanical characteristics. During decubitus, in such patients, the more dependent parts of the lung are subjected to gravity force, which together with chronic inflammation may cause, we suppose, one of the following effects during tidal breathing:
- a total closure of the smaller bronchioli
- a cyclic opening and closure of the small airways thus provoking friction and an inflammatory response of mechanical origin.
The Fraction of Exhaled Nitric Oxyde (FeNO) concentration is largely used in clinical practice as a marker to monitor the lung inflammatory status.
The purpose of the study is to evaluate the possible mechanical origin of the bronchial inflammation in correlation with prolonged supine decubitus, and so use the NO as an index of the small airways impairment in COPD patients.
To do this we will measure the exhaled NO concentration in COPD patients with moderate to severe obstruction, that is a Forced Expiratory Volume less than 70% of predicted value (FEV1<70%pred). The evaluation will be done in four different moments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of informed consent
- •COPD patients with age raging from 50 to 85 years old
- •Patients with at least a history of COPD of one year
- •COPD patients clinically stable in the last three months
- •COPD subjects with FEV1<70% of predicted value
- •FEV1/FVC <88% (males) or <89% (females) of LLN
- •COPD former or active smokers with at least a smoking history of 20 pack year
排除标准
- •Acute Bronchial Exacerbation at recruitment
- •Fertile women with age between 18 and 50 years old or with active period
- •Pregnancy
- •Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment.
- •FEV1/FVC more than 70% of predicted value in basal conditions
- •FEV1 more than 70% of predicted value in basal conditions
- •Known deficit of alpha 1 antitrypsin
- •Subjects that underwent a Lung Volume Reduction Surgery (LVRS)
- •Subjects with known positivity to Human Immunodeficiency Virus (HIV)
- •Misuse of alcool or drugs
- •Lack of compliance in performing respiratory tests
- •Subjects not capable to follow the study prescriptions because of psychic disorders or language problems.
- •Long Term Oxygen Therapy with flows > 6 litres per minute (l/min) at rest
研究组 & 干预措施
COPD FEV1<70%pred feNO Cardioline Exp'air
COPD subjects with FEV1<70% of predicted value and Forced Expiratory Volume Forced to Forced Vital Capacity ratio (FEV1/FVC) less than 88% (males)or less than 89% (females) of Low Levels of Normality (LLN) entering the respiratory rehabilitation unit will undergo multiflow feNo measure with Cardioline Exp'air by Medi-soft - Sorinnes (B)
干预措施: Cardioline Exp'air by Medi-soft - Sorinnes (B) (Device)
结局指标
主要结局
Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle
时间窗: The exhaled NO concentration will be assessed in two different moments: the day immediately after the hospitalization (t0) and after 15 days (t1) of rehabilitation activity
NO concentration will be evaluated in four different sessions at t0 and t1: 1) immediately after the patient goes to bed while he is in supine position; 2) when the patient wakes up, when he's still in the bed in supine position; 3) in sitted position after 5 deep inspirations to total lung capacity 4) after one hour of normal morning activity, again in sitted position. The NO measurements will be collected by a portable NO analyzer at the patient's bed.
次要结局
未报告次要终点
研究者
Pierachille Santus
Head of Pulmonary Rehabilitation Unit
University of Milan