Effect of Prolonged Decubitus on Nitric Oxide Concentration in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Airway Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pressure Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      -  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.
    

Detailed description: 
      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:

        1. before the patient goes to sleep while in supine position

        2. immediately after the patient wakes up in the morning, still being in supine position.

        3. while sitting on the bed after point 2

        4. in the morning after one hour of normal patient's activities, in seated position.

      Together with NO concentration, also the Respiratory Frequency and Tidal Volume will be
      registered during each evaluation.

      All the subjects will be inpatients accessing a respiratory rehabilitation unit. At the
      beginning and after 15 days of rehabilitation a functional respiratory assessment will be
      made (spirometry, plethysmography, Carbon Monoxide (CO) diffusion lung test), together with
      an arterial blood gas analysis and a 6 minutes walking test (WT6').

      An initial and a final assessment of dyspnoea will be made by Borg and Modified Medical
      Research Council (mMRC) scales. For the study duration all the patients will continue their
      inhaled therapy as usual (an ultra long acting anticholinergic once daily plus a long acting
      Beta-2 agonist in combination with an inhaled corticosteroid twice daily)
    

Intervention name(s): Cardioline Exp'air by Medi-soft - Sorinnes (B)
Intervention type(s): Device
Intervention description(s): FeNO measurement in four different moments, the first in the evening, the last three in the morning of the day after. These evaluations will be repeated when the patient enters the unit and after 15 days of rehabilitation activity
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: COPD; FeNO; Bronchial inflammation; Small airways; Decubitus