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

This study has been terminated.
(The publication of a national guideline on NPPV precluded further recruitment.)
Sponsor:
Information provided by (Responsible Party):
Dr. Thomas Koehnlein, Deutsche Lungenstiftung e.V.
ClinicalTrials.gov Identifier:
NCT00710541
First received: January 22, 2008
Last updated: August 12, 2013
Last verified: August 2013
  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, 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 Intervention
Chronic Obstructive Pulmonary Disease
Hypercapnia
Device: ventilators designed for non invasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)

Resource links provided by NLM:


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 ]

Enrollment: 195
Study Start Date: October 2004
Study Completion Date: December 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Responsible Party: Dr. Thomas Koehnlein, M.D., Deutsche Lungenstiftung e.V.
ClinicalTrials.gov Identifier: NCT00710541     History of Changes
Other Study ID Numbers: COPD-Study, COPD1
Study First Received: January 22, 2008
Last Updated: August 12, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsche Lungenstiftung e.V.:
non invasive ventilation
COPD
hypercapnia
GOLD stage IV

Additional relevant MeSH terms:
Hypercapnia
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Signs and Symptoms, Respiratory
Signs and Symptoms
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 25, 2014