Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
NCT ID: NCT01037387
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-12-31
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Conventional treatment for COPD
Control
Current treatment according to the ATS/ERS guidelines
NIMV group
NIMV: Conventional treatment plus noninvasive mechanical ventilation
NIMV group
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Interventions
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Control
Current treatment according to the ATS/ERS guidelines
NIMV group
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
45 Years
75 Years
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Responsible Party
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Francisco Garcia-Rio
MD
Principal Investigators
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Maria Antonia Gómez-Mendieta
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Locations
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Hospital Universitario La Paz
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HULP PI-825
Identifier Type: -
Identifier Source: org_study_id
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