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

NCT01555593 | Completed Phase 4 DMC

• 1 other identifier: 630CEC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Airway Disease

Keywords

COPD; FeNO; Bronchial inflammation; Small airways; Decubitus

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Study Arms (1)

COPD FEV1<70%pred feNO Cardioline Exp'air

EXPERIMENTAL

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)

Device: Cardioline Exp'air by Medi-soft - Sorinnes (B)

Interventions

Cardioline Exp'air by Medi-soft - Sorinnes (B) DEVICE

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

COPD FEV1<70%pred feNO Cardioline Exp'air

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• Fondazione Salvatore Maugeri: collaborator

Study Sites (1)

: Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS

Milan, Milano, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pressure Ulcer

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pierachille Santus, Md, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pulmonary Rehabilitation Unit

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

IT (1)