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

Phase 4

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic
• Interventions: Drug: Control; Device: NIMV group

• Registration Number: NCT01037387
• Lead Sponsor: Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06
• Study Start: 2025-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Conventional treatment for COPD
NIMV group	NIMV group	NIMV: Conventional treatment plus noninvasive mechanical ventilation

Primary Outcome Measures

Name	Time	Method
daily physical activity and plasmatic concentration of C-reactive protein	12 months

Secondary Outcome Measures

Name	Time	Method
Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane	12 months
PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD	12 months
Adverse effects	12 months
Cardiovascular effects, exacerbations, hospitalizations and mortality	12 months
BDI/TDI, SF-36, SGRQ, LCADL	12 months

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain