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

NCT00710541 | Terminated DMC

• 2 other identifiers: COPD-StudyCOPD1
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Hypercapnia

Keywords

non invasive ventilation; COPD; hypercapnia; GOLD stage IV

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  one year

Secondary Outcomes (1)

• exercise capacity

  one year

Study Arms (2)

NPPV group

EXPERIMENTAL

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

control gorup

NO INTERVENTION

Subjects in this arm receive standard COPD treatment and LTOT if indicated.

Interventions

ventilators designed for non invasive ventilation DEVICE

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.

Also known as: Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330

NPPV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Deutsche Lungenstiftung e.V.: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Related Publications (2)

• Kohnlein T, Criee CP, Kohler 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. doi: 10.1055/s-2004-818542. German.

  PMID: 15293170 BACKGROUND

• Kohnlein T, Windisch W, Kohler D, Drabik A, Geiseler J, Hartl S, Karg O, Laier-Groeneveld G, Nava S, Schonhofer B, Schucher B, Wegscheider K, Criee CP, Welte T. Non-invasive positive pressure ventilation for the treatment of severe stable chronic obstructive pulmonary disease: a prospective, multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2014 Sep;2(9):698-705. doi: 10.1016/S2213-2600(14)70153-5. Epub 2014 Jul 24.

  PMID: 25066329 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Carl P Criée, Professor

  Krankenhaus Göttingen-Weende, Klinik Lenglern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: July 4, 2008
• Study Start: October 1, 2004
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: August 14, 2013

Record last verified: 2013-08

Locations

DE (1)