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Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment

Phase 4
50 Years
85 Years
Open (Enrolling)
Chronic Obstructive Airway Disease

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Trial Information

Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment

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)

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Pierachille Santus, Md, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO


Italy: Ethics Committee

Study ID:




Start Date:

March 2012

Completion Date:

January 2013

Related Keywords:

  • Chronic Obstructive Airway Disease
  • COPD
  • FeNO
  • Bronchial inflammation
  • Small airways
  • Decubitus
  • Pressure Ulcer
  • Inflammation
  • Lung Diseases
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive