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

NCT01037387 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-03-06

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • Maria Antonia Gómez-Mendieta · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037387 on ClinicalTrials.gov