Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
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.
Chronic Obstructive Pulmonary Disease
Device: NIMV group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD|
- daily physical activity and plasmatic concentration of C-reactive protein [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- BDI/TDI, SF-36, SGRQ, LCADL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Cardiovascular effects, exacerbations, hospitalizations and mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||June 2018|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Control
Conventional treatment for COPD
Current treatment according to the ATS/ERS guidelines
Other Name: Bronchodilator agents and inhaled corticosteroids
Experimental: NIMV group
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Device: NIMV group
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Other Name: Bronchodilator agents and inhaled corticosteroids.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037387
|Contact: María Antonia Gomez-Mendieta, MDfirstname.lastname@example.org|
|Hospital Universitario La Paz||Recruiting|
|Madrid, Spain, 28034|
|Contact: María Antonia Gómez-Mendieta, MD 917277253 email@example.com|
|Principal Investigator: María Antonia Gomez-Mendieta, MD|
|Principal Investigator: Claudia Llontop|
|Principal Investigator: Francisco Garcia-Rio, PhD|
|Principal Investigator:||Maria Antonia Gómez-Mendieta||Hospital Universitario La Paz|