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COPDPhase 2/3AVAPS-AENCT01601977

Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 2/3 study testing AVAPS-AE in people with COPD and OSA, run by Patrick Murphy at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 90 years
Conditions the study is for
COPD, OSA
What is being tested?
AVAPS-AE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
May 2012to Sep 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 21
  • Diagnosis of COPD
  • Currently using Bilevel device for COPD-OSA overlap syndrome
  • Ability to provide consent
  • Documentation of medical stability by PI

Who cannot join

  • Subjects, who are acutely ill, medically complicated or who are medically unstable.
  • Subjects in whom PAP therapy is otherwise medically contraindicated.
  • Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
  • Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • St Thomas' Hospital

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: Validation of the AVAPS AE Algorithm in Chronic Obstructive Pulmonary Disease: A Non-randomised Pilot Study

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.

Read the 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.

Conditions
COPD, OSA
Being tested
AVAPS-AE, Usual care
Keywords
COPD, Respiratory failure, NIV, OSA
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVAPS-AEDevice

    Novel ventilation mode (Omnilab - AVAPS AE algorithm)

  • Usual careDevice

    Non-invasive ventilation with standard ventilator

Study groups in NCT01601977
Study groupRoleWhat they receive
InterventionExperimentalAVAPS-AE
Receives: Device: AVAPS-AE
Usual careActive comparatorNon-invasive ventilation
Receives: Device: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Control of Nocturnal Hypoventilation

    transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device

    Measured: baseline, 6 week assessment

Secondary outcomes (6)
  1. Health Related Quality of Life

    Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)

    Measured: 2 weeks

  2. Health Related Quality of Life

    Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)

    Measured: 6 weeks

  3. Total Sleep Time

    Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST

    Measured: baseline, 6 weeks

  4. Control of Nocturnal Hypoventilation

    mean tcCO2

    Measured: 2 weeks

  5. Exercise Capacity

    6 minute walk test

    Measured: 6 weeks

  6. Exacerbation Frequency

    patient reported exacerbations following 6 weeks of device usage

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601977
Sponsor's protocol ID
AVAPS AE in COPD
Acronym
AVAPS-AE
Status last verified
Jul 2016
First submitted
17 May 2012
Last updated
18 Aug 2016
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AVAPS-AE in people with COPD and OSA, run by Patrick Murphy at 1 site in United Kingdom.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Aug 2016. 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 United Kingdom. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Control of Nocturnal Hypoventilation (time frame: baseline, 6 week assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Aug 2016.

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