Impact of noninvasive ventilation on 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
This study tests whether using a noninvasive breathing machine for a year can help people with COPD feel more active and reduce inflammation compared to regular treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Universitario La Paz Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT01037387 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of 12 months of noninvasive mechanical ventilation compared to conventional treatment in patients with stable hypercapnic Chronic Obstructive Pulmonary Disease (COPD). It aims to assess changes in physical activity levels and inflammation markers, specifically C-reactive protein concentrations. The study also seeks to analyze other inflammatory biomarkers, breathlessness, quality of life, and lung function responses to the treatment. Participants will be monitored for their clinical stability and treatment optimization over the past two years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45-75 with stable hypercapnic COPD and specific lung function criteria.
Not a fit: Patients with other respiratory diseases, significant obesity, or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve physical activity and reduce inflammation in COPD patients, enhancing their overall quality of life.
How similar studies have performed: Previous studies have shown promising results with noninvasive ventilation in COPD management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Maria Antonia Gómez-Mendieta — Hospital Universitario La Paz
- Study coordinator: María Antonia Gomez-Mendieta, MD
- Email: fgr01m@gmail.com
- Phone: 34917277253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.