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

NCT01853787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2015-07-10

No results posted yet for this study

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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Formoterol Fumarate

Formoterol Fumarate, one inhalation of 12 mcg via MDI (Metered Dose Inhaler) Modulite will be taken in double blind randomized way immediately after T0 evaluation.

DRUG

Salmeterol

Salmeterol 50 mcg via MDI (Metered Dose Inhaler), one inhalation only, immediately after T0 evaluation

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    collaborator OTHER

  • Università degli Studi di Ferrara

    collaborator OTHER

  • University of Milan

    lead OTHER

Principal Investigators

  • Pierachille santus, Md, PhD · Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853787 on ClinicalTrials.gov