Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients - SANOB Study

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 mediators like 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.

• NO is produced in response to physical and chemical stress on bronchial epithelium and plays a critical role in small airways remodelling

• Exhaled NO concentration is usually used to monitor bronchial inflammation

• The relationship between stretch and strain of small airways and bronchial inflammation is not well understood.

• The investigators hypothesis is that cyclic opening and closure of peripheral obstructed airways through the consequent stretching and strain acting on them can provoke an inflammatory response which can be monitored by exhaled NO.

• The pharmacological effects of bronchodilators may play a role on bronchial inflammation by reducing the stretching stress on bronchiolar walls thus reducing the production of NO in exhalate

• Data about these physiopathological aspects is missing in literature.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Collaborators: Fondazione Salvatore Maugeri; Università degli Studi di Ferrara
• Treatments: Formoterol Fumarate; Nitric Oxide; Salmeterol Xinafoate

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 (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