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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
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 22, 2009
Last Updated
March 2, 2023
Sponsor
Hospital Universitario La Paz
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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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