Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation
![]() |
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: NCT01513655 |
Recruitment Status : Unknown
Verified November 2018 by Kasper Linde Ankjaergaard, MD, University Hospital, Gentofte, Copenhagen.
Recruitment status was: Recruiting
First Posted : January 20, 2012
Last Update Posted : November 16, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Background: In chronic obstructive pulmonary disease, the prognosis for patients who have survived an episode of acute hypercapnic respiratory failure due to an exacerbation is poor. Despite being shown to improve survival and quality-of-life in stable patients with chronic hypercapnic respiratory failure, long-term noninvasive ventilation is controversial in unstable patients with frequent exacerbations, complicated by acute hypercapnic respiratory failure. In an uncontrolled group of patients with previous episodes of acute hypercapnic respiratory failure, treated with noninvasive ventilation, we have been able to reduce mortality and the number of repeat respiratory failure and readmissions by continuing the acute noninvasive ventilatory therapy as a long-term therapy.
Methods: Multi-center open label randomized controlled trial of 150 patients having survived an admission with noninvasive ventilatory treatment of acute hypercapnic respiratory failure due chronic obstructive pulmonary disease. The included patients are randomized to usual care or to continuing the acute noninvasive ventilation as a long-term therapy, both with a one-year follow-up period.
End points: The primary endpoint is one-year mortality; secondary endpoints are time to death or repeat acute hypercapnic respiratory failure, number of readmissions and repeat acute hypercapnic respiratory failure, exacerbations, dyspnea, quality of life, sleep quality, lung function, and arterial gases.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease Acute Exacerbation of Chronic Obstructive Airways Disease Chronic Hypercapnic Respiratory Failure | Device: LTNIV | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | July 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: LTNIV group
LTNIV group is discharged with the ventilator and the settings and pressures which reversed the respiratory failure and the hypercapnic acidosis. We know the patients are able to tolerate these settings. The ventilators are Philips A30. The patients must use the ventilator for a minimum of six hours a night. Furthermore, the patients are discharged with usual care, i.e., the golden standard of COPD treatment as described in GOLD-guidelines. Outpatient visits are given every three months. |
Device: LTNIV
LTNIV with the ventilator and the settings and pressures which reversed the respiratory failure and the hypercapnic acidosis. We know the patients are able to tolerate these settings. The ventilators are Philips A30. The patients must use the ventilator for a minimum of six hours a night.
Other Names:
|
No Intervention: Control group
Patients in the control group are discharged with usual care, i.e., the golden standard of COPD treatment as described in GOLD-guidelines. Outpatient visits are given every three months. |
- Time to death or repeat AHRF with need of NIV [ Time Frame: 1 year ]
Measured by Kaplan Meier plot and log rank with a Cox proportional hazards regression. Intention-to-treat analysis.
Secondarily, mortality will be analyzed as Per-protocol as well
- Hospitalizations (time to - and absolute number) [ Time Frame: 1 year ]Measured by Kaplan Meier plot, logrank and absolute data. Both ITT and PP
- Health related quality of life [ Time Frame: 1 year ]measured by the CAT and SRI questionnaires
- medication status [ Time Frame: 1 year ]use of medication during one year's follow-up
- Dyspnea [ Time Frame: 1 year ]The MRC dyspnea scale
- Number of contacts with ER, GP because of COPD [ Time Frame: 1 year ]Comparison of absolute numbers
- Number of days admitted [ Time Frame: 1 year ]Comparison of absolute numbers
- Mortality [ Time Frame: 1 year ]
Measured by Kaplan Meier plot and log rank with a Cox proportional hazards regression. But also a comparison of absolute numbers.
Intention-to-treat analysis.
- Number of repeat AHRF with need for NIV [ Time Frame: 1 year ]
Measured by Kaplan Meier plot and log rank with a Cox proportional hazards regression. But also a comparison of absolute numbers.
Intention-to-treat analysis.

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient admitted with a NIV-requiring exacerbation of COPD
- COPD with a FEV1/FVC <0.7 after bronchodilatation.
- ≥ 1 acute hypercapnic respiratory failure (AHRF *).
- Optimal medical treatment of COPD, ie. inhaled steroids, long-acting β2-agonist Tiotropium, according to GOLD guidelines.
- Address in Capital Region
- Patients are able to give verbal consent and sign a written consent form and understand Danish-
Exclusion Criteria:
- Severely depressed level of consciousness / confusion / non-cooperative.
- Respiratory rate <12/min
- Severe hypoxia, such as requiring more than 15L O2/min.
- Large amounts of sputum.
- Vomiting and high risk for aspiration.
- Inability to accept NIV.
- Recent abdominal, facial or upper airway surgery.
- Malignancy or life expectancy <6 months because of disease other than COPD
- Known obstructive sleep apnea syndrome (OSA)
- Metabolic acidotic component - StHCO3- < 20 mM

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): NCT01513655
Contact: Philip Tønnesen, MDSc | +45 21279858 | phtoe@geh.regionh.dk | |
Contact: Kasper L Ankjærgaard, MD | +45 29922755 | ankjaergaard@live.dk |
Denmark | |
Dept. of Pulmonary Medicine Y, UH Gentofte | Recruiting |
Hellerup, Denmark, DK-2900 | |
Contact: Philip Tønnesen, dr.med.sci +45 21279858 phtoe@geh.regionh.dk | |
Contact: Kasper L Ankjærgaard, MD +45 29922755 ankjaergaard@live.dk | |
Dept. of Internal Medicine O, UH Herlev | Recruiting |
Herlev, Denmark, DK-2730 | |
Contact: Lars C Laursen, dr.med.sci +45 38 68 38 68 lachla01@heh.regionh.dk | |
Dept. of Pulmonary Medicine and Cardiology, UH Hvidovre | Recruiting |
Hvidovre, Denmark, DK-2650 | |
Contact: Ejvind Frausing, MD +45 38 62 22 53 ejvind.frausing@hvh.regionh.dk | |
Dept. of Pulmonary Medicine, L, UH Bispebjerg | Recruiting |
København NV, Denmark, DK-2400 | |
Contact: Helle F Andreassen, MD PhD Helle.Andreassen@regionh.dk |
Study Chair: | Philip Tønnesen, MDSc | Chair of dept., Dept. of Pulmonary Medicine, UH Gentofte |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kasper Linde Ankjaergaard, MD, MD. ph.d-student, University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT01513655 |
Other Study ID Numbers: |
2011-004866-13 |
First Posted: | January 20, 2012 Key Record Dates |
Last Update Posted: | November 16, 2018 |
Last Verified: | November 2018 |
COPD Home NIV NIV |
Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Insufficiency |
Lung Diseases Respiratory Tract Diseases Respiration Disorders |