NCT01037387

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Hypercapnic

Interventions

Type	Name	Description
DRUG	Control	Current treatment according to the ATS/ERS guidelines
DEVICE	NIMV group	Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).

Timeline

• Start date: 2025-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2009-12-23
• Last updated: 2023-03-06

Locations

1 site across 1 country: Spain