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NCT01037387 | RECRUITING | Chronic Obstructive Pulmonary Disease

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

La Paz University Hospital

Information provided by (Responsible Party):

Francisco Garcia-Rio

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.

Condition or disease

Chronic Obstructive Pulmonary Disease

Hypercapnic

Intervention/treatment

Control

NIMV group

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
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
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients

Location Details

NCT01037387

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How to Participate

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Locations

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain, 28034