Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— SANOBOfficial title:
Acute Bronchodilation and Bronchial Inflammation: Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients. Stretching of Airways and Nitric Oxide in Bronchodilation, SANOB Study
Verified date | July 2015 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
- 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.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Italy | Clinica di Malattie dell'Apparato Respiratorio, Dipartimento di Scienze Mediche, Università di Ferrara | Ferrara | |
Italy | : Pneumologia Riabilitativa-Fondazione Maugeri-Istituto Scientifico di Milano- IRCCS | Milano |
Lead Sponsor | Collaborator |
---|---|
University of Milan | Fondazione Salvatore Maugeri, Università degli Studi di Ferrara |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in exhaled Nitric Oxide concentration after Long acting Beta 2 Agonist assumption | The evaluation of exhaled Nitric Oxide concentration will be performed following the schedule below: at baseline (T0), after 72 hours of inhalatory therapy washout 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) 60 minutes after T0 (T2) 180 minutes after T0 (T3) every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. The measurements of Exhaled NO will be performed by Medi-Soft Exp'air FeNo concentration sampling device, Sorinnes (Dinant) Belgium. At every step, will be performed 3 measurements at different flows (50 ml/sec, 100 ml/sec, 150 ml/sec and 350 ml/sec), for a total of 12 valid measurements for each step. Alveolar NO and Bronchial Wall NO concentrations will be taken in consideration. |
- At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption | No |
Secondary | Change in static plethysmographic volumes, assessment of desufflation and resistances after Long acting Beta 2 Agonist assumption and | The evaluation of pulmonary desufflation and pulmonary specific resistances (sRAW) will be performed with a plethysmographic maneuver for each of the following steps: at baseline (T0), after 72 hours of inhalatory therapy washout 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) 60 minutes after T0 (T2) 180 minutes after T0 (T3) every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. The considered pulmonary volumes will be the Residual Volume and the Functional Residual Capacity, while Specific Resistances of AirWays (sRAW)will be evaluated using a Jaeger (Germany) plethysmographic cabin. At every step, 3 measurements will be performed, following the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines on pulmonary Function testing. |
At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption | No |
Secondary | Diffusion Lung Capacity for Carbon Monoxide (DLCO) and Alveolar Volume (VA) variation from baseline | The evaluation of DLCO and VA will be assessed performing the Single Breath method for each of the following steps: at baseline (T0), after 72 hours of inhalatory therapy washout 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) 60 minutes after T0 (T2) 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. DLCO and VA will be obtained using a Jaeger (Germany) pneumotachograph with an integrated gas analyzer, by means of a fixed gas mixture made as follows : 10% Helium, 6% Carbon Monoxide, 84% Nitrogen At every step 3 consecutive measurements will be performed, following the ATS/ERS guidelines on pulmonary Function testing. |
At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption | No |
Secondary | Modification of arterial gases concentration after bronchodilator therapy in acute conditions | An arterial blood sampling will be taken for each of the following steps: at baseline (T0), after 72 hours of inhalatory therapy washout 180 minutes after T0 (T3) Every patient will repeat the same two steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. Partial arterial pressure of Oxygen and Partial arterial pressure of Carbon Dioxide will be obtained using a arterial gas analyzer GEM Premier 3000 |
At baseline, after 180 minutes of LABA assumption | No |
Secondary | Closing Capacity variability from baseline at the Single Breath Nitrogen Washout test | The evaluation of the appearance of the CLosing Capacity (CC) will be assessed performing the Single Breath Nitrogen Washout test (SBN2 test) for each of the following steps: at baseline (T0), after 72 hours of inhalatory therapy washout 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) 60 minutes after T0 (T2) 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. The CC will be obtained using Vmax, Jaeger (Germany) pneumotachograph with an integrated gas analyzer. The parameters considered will be the phase III (alveolar phase) and the phase IV (Closing Capacity appearance) at the SBN2 test. At every step 3 consecutive measurements will be performed, following the ATS/ERS guidelines on pulmonary function testing. |
At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption | No |
Secondary | Change from baseline in dyspnoea, evaluated with VAS (Visual Analogue Scale). | The evaluation of grade of dyspnea will assessed through the VAS scale for each of the following steps: at baseline (T0), after 72 hours of inhalatory therapy washout 30 minutes (T1) after the assumption of a inhaled bronchodilator (Salmeterol 50 mcg or Formoterol 12 mcg) 60 minutes after T0 (T2) 180 minutes after T0 (T3) Every patient will repeat the same four steps in two different days after 72 hours of pharmacological washout, crossing over in blind conditions the bronchodilator taken the previous study day. |
At baseline, after 30 minutes of LABA assumption, after 60 minutes of LABA assumption, after 180 minutes of LABA assumption | No |
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