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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01037387
Recruitment Status : Recruiting
First Posted : December 23, 2009
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):
Francisco Garcia-Rio, Hospital Universitario La Paz

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Hypercapnic Drug: Control Device: NIMV group Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD
Study Start Date : December 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
Conventional treatment for COPD
Drug: Control
Current treatment according to the ATS/ERS guidelines
Other Name: Bronchodilator agents and inhaled corticosteroids
Experimental: NIMV group
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Device: NIMV group
Current treatment according to the ATS/ERS guidelines and nocturnal BiPAP (IPAP 10-20 cmH2O,EPAP 4-6 cmH2O).
Other Name: Bronchodilator agents and inhaled corticosteroids.

Primary Outcome Measures :
  1. daily physical activity and plasmatic concentration of C-reactive protein [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane [ Time Frame: 12 months ]
  2. PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD [ Time Frame: 12 months ]
  3. BDI/TDI, SF-36, SGRQ, LCADL [ Time Frame: 12 months ]
  4. Adverse effects [ Time Frame: 12 months ]
  5. Cardiovascular effects, exacerbations, hospitalizations and mortality [ Time Frame: 12 months ]

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01037387

Contact: María Antonia Gomez-Mendieta, MD 34917277253

Hospital Universitario La Paz Recruiting
Madrid, Spain, 28034
Contact: María Antonia Gómez-Mendieta, MD    917277253   
Principal Investigator: María Antonia Gomez-Mendieta, MD         
Principal Investigator: Claudia Llontop         
Principal Investigator: Francisco Garcia-Rio, PhD         
Sponsors and Collaborators
Hospital Universitario La Paz
Principal Investigator: Maria Antonia Gómez-Mendieta Hospital Universitario La Paz

Responsible Party: Francisco Garcia-Rio, MD, Hospital Universitario La Paz Identifier: NCT01037387     History of Changes
Other Study ID Numbers: HULP PI-825
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents