Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Verified date | August 2013 |
Source | Deutsche Lungenstiftung e.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
Non-invasive ventilation is frequently applied in patients with acute exacerbation of COPD,
but no evidence exists about the effect of long term application/home application.
This study tests the hypothesis, that a daily, 6 hour application of non-invasive
ventilation over one year improves survival, exercise capacity, and quality of life in
patients with advanced stages of COPD.
Status | Terminated |
Enrollment | 195 |
Est. completion date | December 2012 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Moderate or severe COPD with insufficiency of the ventilatory pump (according to GOLD stage IV). Stable disease since four weeks or more prior to randomisation. The COPD might be caused by whatever reason (smoking, Alpha-1 antitrypsin deficiency, ....). Smokers can be included. - Capillary PCO2 of 7 kPa (51,8 mmHg) or maximally 10 kPa (74 mmHg), combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position. Patients on long term oxygen treatment must inhale oxygen in their prescribed dose. - Only patients in the age of 18 years or above can be included. - Written information about all aspects of the study (available in German language) must be provided for each patient. Written informed consent prior to any measure of this protocol is necessary for inclusion. Exclusion Criteria: - Patients with a PCO2 of 10 kPa (74 mmHg) or above. These patients can be re-evaluated for inclusion after 4 weeks. - Diseases of the lung or thorax besides COPD: Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2. - Patients on NIV. - Body mass index of 35 kg/m² or above. - Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion). - Malignoma - Disorders of the basal brain nerves with derangement of swallowing, or reflexes of swallowing and choking. - Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus. - Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Medizinische Hochschule Hannover | Hannover |
Lead Sponsor | Collaborator |
---|---|
Deutsche Lungenstiftung e.V. |
Germany,
Köhnlein T, Criée CP, Köhler D, Welte T, Laier-Groeneveld G. [Multicenter study on "non-invasive ventilation in patients with severe chronic obstructive pulmonary disease and emphysema(COPD)"]. Pneumologie. 2004 Aug;58(8):566-9. German. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all-cause mortality | one year | No | |
Secondary | exercise capacity | one year | No |
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