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

NCT01513655 | Unknown Phase 4 DMC

• 1 other identifier: 2011-004866-13
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease; Acute Exacerbation of Chronic Obstructive Airways Disease; Chronic Hypercapnic Respiratory Failure

Keywords

COPD; Home NIV; NIV

Outcome Measures

Primary Outcomes (1)

• Time to death or repeat AHRF with need of NIV

  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

  1 year

Secondary Outcomes (8)

• Hospitalizations (time to - and absolute number)

  1 year

• Health related quality of life

  1 year

• medication status

  1 year

• Dyspnea

  1 year

• Number of contacts with ER, GP because of COPD

  1 year

Study Arms (2)

LTNIV group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

LTNIV DEVICE

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.

Also known as: Philips BiPAP A30 AVAPS, SmartCard reader 1003543

LTNIV group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Philips Respironics: collaborator

Study Sites (4)

Dept. of Pulmonary Medicine Y, UH Gentofte

Hellerup, DK-2900, Denmark

RECRUITING

Dept. of Internal Medicine O, UH Herlev

Herlev, DK-2730, Denmark

RECRUITING

Dept. of Pulmonary Medicine and Cardiology, UH Hvidovre

Hvidovre, DK-2650, Denmark

RECRUITING

Dept. of Pulmonary Medicine, L, UH Bispebjerg

København NV, DK-2400, Denmark

RECRUITING

Related Publications (11)

• Ram FS, Wellington S, Rowe BH, Wedzicha JA. Non-invasive positive pressure ventilation for treatment of respiratory failure due to severe acute exacerbations of asthma. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004360. doi: 10.1002/14651858.CD004360.pub2.

  PMID: 15674944 BACKGROUND

• Chu CM, Chan VL, Lin AW, Wong IW, Leung WS, Lai CK. Readmission rates and life threatening events in COPD survivors treated with non-invasive ventilation for acute hypercapnic respiratory failure. Thorax. 2004 Dec;59(12):1020-5. doi: 10.1136/thx.2004.024307.

  PMID: 15563699 BACKGROUND

• Cheung AP, Chan VL, Liong JT, Lam JY, Leung WS, Lin A, Chu CM. A pilot trial of non-invasive home ventilation after acidotic respiratory failure in chronic obstructive pulmonary disease. Int J Tuberc Lung Dis. 2010 May;14(5):642-9.

  PMID: 20392360 BACKGROUND

• Kolodziej MA, Jensen L, Rowe B, Sin D. Systematic review of noninvasive positive pressure ventilation in severe stable COPD. Eur Respir J. 2007 Aug;30(2):293-306. doi: 10.1183/09031936.00145106. Epub 2007 Apr 25.

  PMID: 17459893 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 BACKGROUND

• Funk GC, Breyer MK, Burghuber OC, Kink E, Kirchheiner K, Kohansal R, Schmidt I, Hartl S. Long-term non-invasive ventilation in COPD after acute-on-chronic respiratory failure. Respir Med. 2011 Mar;105(3):427-34. doi: 10.1016/j.rmed.2010.09.005. Epub 2010 Nov 26.

  PMID: 21111590 BACKGROUND

• Struik FM, Sprooten RT, Kerstjens HA, Bladder G, Zijnen M, Asin J, Cobben NA, Vonk JM, Wijkstra PJ. Nocturnal non-invasive ventilation in COPD patients with prolonged hypercapnia after ventilatory support for acute respiratory failure: a randomised, controlled, parallel-group study. Thorax. 2014 Sep;69(9):826-34. doi: 10.1136/thoraxjnl-2014-205126. Epub 2014 Apr 29.

  PMID: 24781217 BACKGROUND

• Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.

  PMID: 20843247 BACKGROUND

• Mullerova H, Maselli DJ, Locantore N, Vestbo J, Hurst JR, Wedzicha JA, Bakke P, Agusti A, Anzueto A. Hospitalized exacerbations of COPD: risk factors and outcomes in the ECLIPSE cohort. Chest. 2015 Apr;147(4):999-1007. doi: 10.1378/chest.14-0655.

  PMID: 25356881 BACKGROUND

• Ankjaergaard KL, Tonnesen P, Laursen LC, Hansen EF, Andreassen HF, Wilcke JT. Home Non Invasive Ventilation (NIV) treatment for COPD patients with a history of NIV-treated exacerbation; a randomized, controlled, multi-center study. BMC Pulm Med. 2016 Feb 12;16:32. doi: 10.1186/s12890-016-0184-6.

  PMID: 26867542 DERIVED

• Esquinas AM, Matsuoka Y, Stieglitz S. Predicting survival after acute exacerbation chronic obstructive pulmonary disease (ACOPD): is long-term application of noninvasive ventilation the last life guard? Int J Chron Obstruct Pulmon Dis. 2013;8:379-81. doi: 10.2147/COPD.S49455. Epub 2013 Aug 7. No abstract available.

  PMID: 24009417 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Philip Tønnesen, MDSc

  Chair of dept., Dept. of Pulmonary Medicine, UH Gentofte

  STUDY CHAIR

Central Study Contacts

Philip Tønnesen, MDSc

CONTACT

+45 21279858; phtoe@geh.regionh.dk

Kasper L Ankjærgaard, MD

CONTACT

+45 29922755; ankjaergaard@live.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. ph.d-student

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: July 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: November 16, 2018

Record last verified: 2018-11

Locations

DK (4)