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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario La Paz
• Treatments: Bronchodilator Agents

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.