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

NCT01037387 | Unknown Phase 4

• 1 other identifier: HULP PI-825
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Hypercapnic

Outcome Measures

Primary Outcomes (1)

• daily physical activity and plasmatic concentration of C-reactive protein

  12 months

Secondary Outcomes (5)

• 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

• Adverse effects

  12 months

• Cardiovascular effects, exacerbations, hospitalizations and mortality

  12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Conventional treatment for COPD

Drug: Control

NIMV group

EXPERIMENTAL

NIMV: Conventional treatment plus noninvasive mechanical ventilation

Device: NIMV group

Interventions

Control DRUG

Current treatment according to the ATS/ERS guidelines

Also known as: Bronchodilator agents and inhaled corticosteroids

Control

NIMV group DEVICE

Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).

Also known as: Bronchodilator agents and inhaled corticosteroids.

NIMV group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Interventions

Bronchodilator Agents

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses

Study Officials

• Maria Antonia Gómez-Mendieta

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

María Antonia Gomez-Mendieta, MD

CONTACT

34917277253; fgr01m@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

ES (1)