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

Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic
• Intervention / Treatment: Drug: Control; Device: NIMV group

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: María Antonia Gomez-Mendieta, MD; Phone Number: 34917277253; Email: fgr01m@gmail.com

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Recruiting
    • Hospital Universitario La Paz
    • Contact: María Antonia Gómez-Mendieta, MD; Phone Number: 917277253; Email: fgr01m@gmail.com
    • Principal Investigator: María Antonia Gomez-Mendieta, MD
    • Principal Investigator: Claudia Llontop
    • Principal Investigator: Francisco Garcia-Rio, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Conventional treatment for COPD	Drug: Control; Current treatment according to the ATS/ERS guidelines; Other Names: Bronchodilator agents and inhaled corticosteroids
Experimental: NIMV group; NIMV: Conventional treatment plus noninvasive mechanical ventilation	Device: NIMV group; Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).; Other Names: Bronchodilator agents and inhaled corticosteroids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
daily physical activity and plasmatic concentration of C-reactive protein	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effects	12 months
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
BDI/TDI, SF-36, SGRQ, LCADL	12 months
Cardiovascular effects, exacerbations, hospitalizations and mortality	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Principal Investigator: Maria Antonia Gómez-Mendieta, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2025
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Bronchodilator Agents
• Other Study ID Numbers: HULP PI-825

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No