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

Madrid Health Service

Status and phase: Enrolling; Phase 4

Conditions: Hypercapnic; Chronic Obstructive Pulmonary Disease

Treatments: Drug: Control; Device: NIMV group

Study type: Interventional

Funder types: Other

Identifiers

NCT01037387

HULP PI-825

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

Active Comparator group

Description:

Conventional treatment for COPD

Treatment:

Drug: Control

NIMV group

Experimental group

Description:

NIMV: Conventional treatment plus noninvasive mechanical ventilation

Treatment:

Device: NIMV group