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

M

Madrid Health Service

Status and phase

Enrolling
Phase 4

Conditions

Hypercapnic
Chronic Obstructive Pulmonary Disease

Treatments

Drug: Control
Device: NIMV group

Study type

Interventional

Funder types

Other

Identifiers

NCT01037387
HULP PI-825

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Control
Active Comparator group
Description:
Conventional treatment for COPD
Treatment:
Drug: Control
NIMV group
Experimental group
Description:
NIMV: Conventional treatment plus noninvasive mechanical ventilation
Treatment:
Device: NIMV group

Trial contacts and locations

1

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Central trial contact

María Antonia Gomez-Mendieta, MD

Data sourced from clinicaltrials.gov

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