Status:
COMPLETED
Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients - SANOB Study
Lead Sponsor:
University of Milan
Collaborating Sponsors:
Fondazione Salvatore Maugeri
Università degli Studi di Ferrara
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
45-90 years
Phase:
PHASE4
Brief Summary
* Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is also caused by inflammation of peripheral airways walls. * Neutrophils and other inflammatory mediat...
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, wh...
Eligibility Criteria
Inclusion
- 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 (Forced Expiratory Volume in 1st second)\<70% of predicted value
- FEV1/FVC (Forced Expiratory Volume in 1st second/Forced Vital Capacity) \<88% (males) or \<89% (females) of LLN (Low Levels of Normality)
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01853787
Start Date
July 1 2014
End Date
June 1 2015
Last Update
July 10 2015
Active Locations (2)
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1
Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Scienze Mediche, Università di Ferrara
Ferrara, Ferrara, Italy, 44121
2
: Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS
Milan, Milano, Italy, 20138