Non-Invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD) - Full Text View

Sponsored by:	Deutsche Lungenstiftung e.V.
Information provided by:	Deutsche Lungenstiftung e.V.
ClinicalTrials.gov Identifier:	NCT00710541

Purpose

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, 8 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	Intervention
Chronic Obstructive Pulmonary Disease Hypercapnia	Device: ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Non-Invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Emphysema Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Deutsche Lungenstiftung e.V.:

Primary Outcome Measures:

all-cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

exercise capacity [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Subjects in arm A receive the intervention (non-invasive ventilation)	Device: ventilators designed for 'non invasive ventilation'(Resmed VPAP III ST-A, Weinmann Ventimotion) Patients must use the ventilator for non invasive ventilation as long term treatment for 8 hours daily over one year.
B: No Intervention

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710541

Contacts

Contact: Thomas Köhnlein, MD	49-511-532 ext 3533	koehnlein.thomas@mh-hannover.de
Contact: Tobias Welte, Professor	49-511-532 ext 3530	welte.tobias@mh-hannover.de

Locations

Germany
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, D-30625
Contact: Thomas Köhnlein, MD 49-511-532 ext 3533 koehnlein.thomas@mh-hannover.de
Principal Investigator: Thomas Köhnlein, MD

Sponsors and Collaborators

Deutsche Lungenstiftung e.V.

Investigators

Study Chair:

Carl P Criée, Professor

Krankenhaus Göttingen-Weende, Klinik Lenglern

More Information

Publications:

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.

Responsible Party:	Medizinische Hochschule Hannover ( Dr. Tobias Welte )
Study ID Numbers:	COPD-Studie, COPD1
Study First Received:	January 22, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00710541 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Deutsche Lungenstiftung e.V.:

non invasive ventilation
COPD
hypercapnia
GOLD stage IV

Study placed in the following topic categories:

Pulmonary Emphysema
Signs and Symptoms
Emphysema
Lung Diseases, Obstructive
Respiratory Tract Diseases

Hypercapnia
Lung Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Signs and Symptoms
Emphysema
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Hypercapnia
Lung Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 11, 2009