Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients

Study Overview
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Brief Summary
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Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with stable COPD. Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive protein concentration and daily physical activity in hypercapnic patients with stable COPD. Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers between COPD patients with conventional treatment and wich noninvasive ventilation. To determine the response of breathlessness, health-related quality of life and lung function to noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic response to noninvasive ventilation.

Official Title
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Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD

Conditions
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Chronic Obstructive Pulmonary Disease, Hypercapnic

Intervention / Treatment
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* Drug: Control
* Device: NIMV group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 45-75 yrs. COPD diagnosis (postbronchodilator FEV1/FVC < 0.7) for at least 6 months. FEV1 < 45% predicted Baseline pH 7.35-7.45 Baseline PaCO2>45 mmHg breathing current air Smoking history (>15 pack-year) Clinically stable for at least the last three months Pharmacological treatment optimized in the last two years. Exclusion Criteria: Previous diagnosis of asthma, other airway obstructive disease, sleep apnea syndrome, interstitial lung disease, chest wall disease or neuromuscular disease. Apnea-hypopnea index > 10/h Morbid obesity (BMI > 45 Kg/m2) Previous diagnosis of ischaemic heart disease, cardiac failure, cirrhosis, chronic renal failure, rheumatoid arthritis or other inflammatory disease.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Conventional treatment for COPD | Drug: Control<br>* Current treatment according to the ATS/ERS guidelines<br>* Other names: Bronchodilator agents and inhaled corticosteroids;|
| Experimental: NIMV group<br>NIMV: Conventional treatment plus noninvasive mechanical ventilation | Device: NIMV group<br>* Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).<br>* Other names: Bronchodilator agents and inhaled corticosteroids.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily physical activity and plasmatic concentration of C-reactive protein |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane |  | 12 months | 
| PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD |  | 12 months | 
| BDI/TDI, SF-36, SGRQ, LCADL |  | 12 months | 
| Adverse effects |  | 12 months | 
| Cardiovascular effects, exacerbations, hospitalizations and mortality |  | 12 months |