Chronic Obstructive Pulmonary Disease, Hypercapnic
Conditions
Brief summary
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.
Interventions
DRUGControl
Current treatment according to the ATS/ERS guidelines
DEVICENIMV group
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| daily physical activity and plasmatic concentration of C-reactive protein | 12 months |
Secondary
| Measure | 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 |
Countries
Spain
Contacts
Primary ContactMaría Antonia Gomez-Mendieta, MD
Outcome results
None listed