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

This study is currently recruiting participants.
Verified April 2013 by Hospital Universitario La Paz
Sponsor:
Information provided by (Responsible Party):
Francisco Garcia-Rio, Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01037387
First received: December 22, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Hypercapnic
 Drug: Control
Device: NIMV group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario La Paz:

Primary Outcome Measures:
  • daily physical activity and plasmatic concentration of C-reactive protein [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seric concentrations of homocisteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BDI/TDI, SF-36, SGRQ, LCADL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cardiovascular effects, exacerbations, hospitalizations and mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037387

Contacts
Contact: María Antonia Gomez-Mendieta, MD 34917277253 fgr01m@gmail.com

Locations
Spain
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28034
Contact: María Antonia Gómez-Mendieta, MD     917277253     fgr01m@gmail.com    
Principal Investigator: María Antonia Gomez-Mendieta, MD            
Principal Investigator: Claudia Llontop            
Principal Investigator: Francisco Garcia-Rio, PhD            
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
Principal Investigator: Maria Antonia Gómez-Mendieta Hospital Universitario La Paz
  More Information

No publications provided

Responsible Party: Francisco Garcia-Rio, MD, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01037387     History of Changes
Other Study ID Numbers: HULP PI-825
Study First Received: December 22, 2009
Last Updated: April 1, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on May 21, 2013