CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
AVAPS-AE +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01601977
NCT01601977Phase 3Completed

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

Patrick Murphy·interventional·Posted May 18, 2012·Updated Aug 18, 2016

In Brief

A Phase 3 clinical trial evaluating AVAPS-AE and Usual care for COPD and OSA. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD, OSA
CountriesUnited Kingdom
CollaboratorsPhilips Respironics

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2012
Enrollment StartMay 1, 2012
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.1 years ago

Interventions

AVAPS-AEdevice

Novel ventilation mode (Omnilab - AVAPS AE algorithm)

Usual caredevice

Non-invasive ventilation with standard ventilator