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Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710541
Recruitment Status : Terminated (The publication of a national guideline on NPPV precluded further recruitment.)
First Posted : July 4, 2008
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Koehnlein, Deutsche Lungenstiftung e.V.

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Hypercapnia Device: ventilators designed for non invasive ventilation Not Applicable

Detailed Description:

The key problem of COPD (Chronic Obstructive Pulmonary Disease) is chronic inflammation and obstruction of the small airways. This results in a largely elevated flow resistance and work of breathing. The lungs develop enlarged air spaces (emphysema) with a reduction of alveoli and respiratory surface. Consequences are flattening of the diaphragm and alterations in the thoracic skeleton. COPD patients in advanced stages develop insufficiency of the muscular ventilatory pump. The ventilatory pump may decompensate, if the load of the muscles overruns their capacities. Besides that, an unphysiologically high proportion of the cardiac pump volume must be spent for the demands of the ventilatory muscles. Hypercapnia, and later hypoxaemia, are indicators of a decompensated ventilatory pump.

Theoretically, non-invasive ventilation (NIV) could be a treatment option for patients with advanced COPD and insufficiency of their ventilatory pump. Mechanical non-invasive ventilation provides support for the ventilatory muscles and might counterbalance the elevated intrinsic PEEP.

The physiologic and quality of life aspects of long term application on non-invasive ventilation (over at least one year) will be assessed in this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
Study Start Date : October 2004
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: NPPV group
Subjects in this arm receive standard COPD treatment, LTOT if indicated, and NPPV with ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330)
 Device: ventilators designed for non invasive ventilation
Patients are advised to use the ventilator for non invasive ventilation as long term treatment for at least 6 hours per day over one year.
Other Names:
  • Resmed VPAP III ST-A
  • Weinmann Ventimotion
  • Tyco Healthcare Knight Star 330
No Intervention: control gorup
Subjects in this arm receive standard COPD treatment and LTOT if indicated.


Outcome Measures
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Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: one year ]

Secondary Outcome Measures :
  1. exercise capacity [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00710541


Locations
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Germany
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Sponsors and Collaborators
Deutsche Lungenstiftung e.V.
Investigators
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Study Chair: Carl P Criée, Professor Krankenhaus Göttingen-Weende, Klinik Lenglern
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Thomas Koehnlein, M.D., Deutsche Lungenstiftung e.V.
ClinicalTrials.gov Identifier: NCT00710541    
Other Study ID Numbers: COPD-Study
COPD1 ( Other Identifier: Deutsche Lungenstiftung )
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013
Keywords provided by Dr. Thomas Koehnlein, Deutsche Lungenstiftung e.V.:
non invasive ventilation
COPD
hypercapnia
GOLD stage IV
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypercapnia
Respiratory Tract Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes
Signs and Symptoms, Respiratory