Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD; OSA
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      COPD continues to be a cause of major morbidity for patients. Those patients who also have
      respiratory failure and obstructive sleep apnoea are at higher risk of exacerbations and
      death and have worse health related quality of life than similar COPD patients without
      respiratory failure.

      Treatment options in this group of patients have been limited and data to support the use of
      machines to assist breathing (non-invasive ventilators) in stable patients are limited. A
      major limitation of these devices has been patient acceptance and achieving sufficient
      control of sleep breathing disturbance.

      Currently devices are set at a fixed pressure to support the breathing throughout the night.
      The new software within the trial device will aim to better match the support provided by the
      machine to that needed by the patient. It is hoped that this may offer enhanced comfort as
      well as superior control of respiratory failure.
    

Detailed description: 
      Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality
      worldwide.

      Treatment options for COPD patients consist of medications, such as bronchodilators and
      anti-inflammatory drugs, pulmonary rehabilitation, long term oxygen therapy (LTOT), lung
      volume reduction surgery and lung transplantation. Studies have shown that bronchodilators
      and anti-inflammatory drugs show minor or no benefit on long term outcomes but rather are
      used mainly for symptomatic relief.1 Pulmonary rehabilitation has been demonstrated to
      improve functional status and symptoms but there is lacking evidence on long term outcomes of
      this therapy. 2 Lung volume reduction surgery and lung transplantation is only appropriate
      for a small number of patients; therefore, there is no demonstration of improved long-term
      survival rate.3, 4

      Of these available therapies, few have been shown to significantly improve long term patient
      outcomes. For the severe COPD patient, LTOT is the only treatment that demonstrated prolonged
      survival in controlled studies. 5, 6 But, despite the effectiveness of LTOT, COPD is still
      characterized by a high morbidity and mortality rate.

      Although the treatment of OSA with CPAP therapy has been associated with reduced hospital
      admissions and exacerbations there are possible adverse consequences on pulmonary mechanics
      due to exacerbating hyperinflation.

      Noninvasive positive pressure ventilation (NPPV) is one therapy that may prove beneficial to
      stable COPD patients. NPPV is the use of positive pressure ventilation administered via a
      nasal or full face mask (that covers both the nose and mouth). This type of ventilation has
      become a well established and increasingly used therapeutic option for patients with
      hypercapnic respiratory failure (HRF) due to COPD.7

      NPPV, used nocturnally, may improve nighttime hypoventilation that is common with COPD
      patients. An improvement in nocturnal hypoventilation would reset the respiratory center
      sensitivity for CO2.8 9 This would result in an improvement in daytime gas exchange and sleep
      quality. It is also known that hyperinflation in patients with COPD increases their work of
      breathing, thus fatiguing the respiratory muscles.10 It has been suggested that by applying
      nocturnal NPPV it would allow the respiratory muscles to rest, resulting in muscle function
      recovery, increased muscle strength, reduced tendency for fatigue and improvement in
      pulmonary function and gas exchange.11

      AVAPS AE AVAPS AE is a mode of therapy (Philips Respironics Inc, Monroeville, PA, USA) with
      potential advantages over the currently established modes of noninvasive positive pressure
      ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated
      adjustable IPAP setting to maintain target ventilation with a settable rate of change),
      AutoEPAP and Auto Back up Rate. In particular the automated EPAP algorithm will ensure
      optimal upper airway patency without exacerbating hyperinflation.

      In this study, we are evaluating the AVAPS AE mode as compared to the participant's current
      mode of ventilation. We believe that these automated parameters will allow better nocturnal
      ventilatory control to offset the differing elastic and resistive loads imposed by changes in
      body position during sleep. Furthermore, AVAPS AE will counter the changing ventilatory
      requirements due to alterations in lung volumes and airway resistance during different stages
      of sleep. In summary, the AVAPS AE mode will enable automatic adjustment in response to
      ventilatory changes throughout the night.

      Study Objective The objective of this study is to validate the performance of the AVAPS AE
      therapy in COPD-OSA overlap patients during nocturnal ventilation.
    

Intervention name(s): AVAPS-AE; Usual care
Intervention type(s): Device; Device
Intervention description(s): Novel ventilation mode (Omnilab - AVAPS AE algorithm); Non-invasive ventilation with standard ventilator
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Respiratory failure; NIV; OSA