Effect of Prolonged Decubitus on Nitric Oxide Concentration in Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Milan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Pierachille Santus, University of Milan
ClinicalTrials.gov Identifier:
NCT01555593
First received: March 9, 2012
Last updated: March 14, 2012
Last verified: March 2012
  Purpose
  • 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.

Condition Intervention Phase
Chronic Obstructive Airway Disease
Device: Medi-soft Cardioline Exp'air by Medi-soft, Cardio-Respiratory Instrumentations - Sorinnes (Dinant), BELGIUM
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Prolonged Decubitus on Bronchial Inflammation in COPD Patients Evaluated by Expired NO Concentration Assessment

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • Change of Fraction of Exhaled Nitric Oxide related to patient's change of decubitus before and after a rehabilitation cycle [ 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: March 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate to severe COPD
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
Device: Medi-soft Cardioline Exp'air by Medi-soft, Cardio-Respiratory Instrumentations - Sorinnes (Dinant), BELGIUM
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

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)

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555593

Locations
Italy
: Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS
Milano, Italy
Sponsors and Collaborators
University of Milan
Fondazione Salvatore Maugeri
Investigators
Study Director: Pierachille Santus, Md, PhD Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO
  More Information

No publications provided

Responsible Party: Pierachille Santus, Head of Pulmonary Rehabilitation Unit, University of Milan
ClinicalTrials.gov Identifier: NCT01555593     History of Changes
Other Study ID Numbers: 630CEC
Study First Received: March 9, 2012
Last Updated: March 14, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
COPD
FeNO
Bronchial inflammation
Small airways
Decubitus

Additional relevant MeSH terms:
Pressure Ulcer
Inflammation
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Skin Ulcer
Skin Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014