Chronic Obstructive Pulmonary DiseaseNCT00710541
Non-invasive Ventilation in Severe Chronic Obstructive Pulmonary Disease(COPD)
A study testing ventilators designed for non invasive ventilation in people with Chronic Obstructive Pulmonary Disease and Hypercapnia, run by Deutsche Lungenstiftung e.V. at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypercapnia
- What is being tested?
- ventilators designed for non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2004to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypercapnia
- Being tested
- ventilators designed for non invasive ventilation
- Keywords
- non invasive ventilation, COPD, hypercapnia, GOLD stage IV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilators designed for non invasive ventilationDevice
Also called Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: ventilators designed for non invasive ventilation |
| control gorup | No intervention | Subjects in this arm receive standard COPD treatment and LTOT if indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: one year
Secondary outcomes (1)
exercise capacity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startOct 2004
- Primary completionJul 2011
- Study completionDec 2012
Why it stopped: The publication of a national guideline on NPPV precluded further recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsche Lungenstiftung e.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Thomas Koehnlein, Deutsche Lungenstiftung e.V.
- Investigators
- Carl P Criée, Professor, Study chair, Krankenhaus Göttingen-Weende, Klinik Lenglern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710541
- Sponsor's protocol ID
- COPD-Study
- Other IDs
- COPD1
- Status last verified
- Aug 2013
- First submitted
- 22 Jan 2008
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15293170Kohnlein 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.
PubMed 25066329
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation in Patients With Severe Chronic Obstructive Pulmonary Disease and Lung Emphysema (COPD)
- ClinicalTrials.gov ID
- NCT00710541
- Acronym / sponsor ID
- COPD-Study
- Conditions
- Chronic Obstructive Pulmonary Disease, Hypercapnia
- Keywords
- non invasive ventilation, COPD, hypercapnia, GOLD stage IV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The publication of a national guideline on NPPV precluded further recruitment.
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Deutsche Lungenstiftung e.V.University, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV group | Experimental | Device: ventilators designed for non invasive ventilationSubjects 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) |
| control gorup | No intervention | –Subjects in this arm receive standard COPD treatment and LTOT if indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilators designed for non invasive ventilationAlso: Resmed VPAP III ST-A, Weinmann Ventimotion, Tyco Healthcare Knight Star 330Patients are advised to use the ventilator for non invasive ventilation as long term treatment for at least 6 hours per day over one year. | Device | NPPV group |
Primary outcome
all-cause mortality
Time frame: one year
1 secondary outcome
exercise capacity
Time frame: one year
Results and safety
The study was stopped early (reason given: The publication of a national guideline on NPPV precluded further recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Background: PubMed 15293170Kohnlein 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.
- Derived from this study: PubMed 25066329Kohnlein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl P Criée, Professor study chair
Krankenhaus Göttingen-Weende, Klinik Lenglern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilators designed for non invasive ventilation in people with Chronic Obstructive Pulmonary Disease and Hypercapnia, run by Deutsche Lungenstiftung e.V. at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The publication of a national guideline on NPPV precluded further recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00710541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.