Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Kasper Linde Ankjaergaard, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01513655
First received: January 16, 2012
Last updated: November 23, 2015
Last verified: November 2015
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Acute Exacerbation of Chronic Obstructive Airways Disease
Chronic Hypercapnic Respiratory Failure
Device: LTNIV
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Home Non Invasive Ventilation (NIV) Treatment for COPD-patients After a NIV-treated Exacerbation

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Time to death or repeat AHRF with need of NIV [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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



Secondary Outcome Measures:
  • Hospitalizations (time to - and absolute number) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Measured by Kaplan Meier plot, logrank and absolute data. Both ITT and PP

  • Health related quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    measured by the CAT and SRI questionnaires

  • medication status [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    use of medication during one year's follow-up

  • Dyspnea [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The MRC dyspnea scale

  • Number of contacts with ER, GP because of COPD [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison of absolute numbers

  • Number of days admitted [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Comparison of absolute numbers

  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Philips BiPAP A30 AVAPS
  • SmartCard reader 1003543
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01513655

Contacts
Contact: Philip Tønnesen, MDSc +45 21279858 phtoe@geh.regionh.dk
Contact: Kasper L Ankjærgaard, MD +45 29922755 ankjaergaard@live.dk

Locations
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   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Philips Respironics
Investigators
Study Chair: Philip Tønnesen, MDSc Chair of dept., Dept. of Pulmonary Medicine, UH Gentofte
  More Information

Publications:

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     History of Changes
Other Study ID Numbers: 2011-004866-13 
Study First Received: January 16, 2012
Last Updated: November 23, 2015
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:
COPD
Home NIV
NIV

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

ClinicalTrials.gov processed this record on September 26, 2016