Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease, Hypercapnic
Status
Recruiting
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Control
NIMV group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility 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.
Sites / Locations
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
NIMV group
Arm Description
Conventional treatment for COPD
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Outcomes
Primary Outcome Measures
daily physical activity and plasmatic concentration of C-reactive protein
Secondary Outcome Measures
Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane
PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD
BDI/TDI, SF-36, SGRQ, LCADL
Adverse effects
Cardiovascular effects, exacerbations, hospitalizations and mortality
Full Information
NCT ID
NCT01037387
First Posted
December 22, 2009
Last Updated
March 2, 2023
Sponsor
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT01037387
Brief Title
Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
Official Title
Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2025 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Hypercapnic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional treatment for COPD
Arm Title
NIMV group
Arm Type
Experimental
Arm Description
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
Bronchodilator agents and inhaled corticosteroids
Intervention Description
Current treatment according to the ATS/ERS guidelines
Intervention Type
Device
Intervention Name(s)
NIMV group
Other Intervention Name(s)
Bronchodilator agents and inhaled corticosteroids.
Intervention Description
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Primary Outcome Measure Information:
Title
daily physical activity and plasmatic concentration of C-reactive protein
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane
Time Frame
12 months
Title
PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD
Time Frame
12 months
Title
BDI/TDI, SF-36, SGRQ, LCADL
Time Frame
12 months
Title
Adverse effects
Time Frame
12 months
Title
Cardiovascular effects, exacerbations, hospitalizations and mortality
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
María Antonia Gomez-Mendieta, MD
Phone
34917277253
Email
fgr01m@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Antonia Gómez-Mendieta
Organizational Affiliation
Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Antonia Gómez-Mendieta, MD
Phone
917277253
Email
fgr01m@gmail.com
First Name & Middle Initial & Last Name & Degree
María Antonia Gomez-Mendieta, MD
First Name & Middle Initial & Last Name & Degree
Claudia Llontop
First Name & Middle Initial & Last Name & Degree
Francisco Garcia-Rio, PhD
12. IPD Sharing Statement
Learn more about this trial
Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
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