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

NCT01601977 | Completed Phase 2 Results

• 1 other identifier: AVAPS AE in COPD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD; OSA

Keywords

COPD; Respiratory failure; NIV; OSA

Outcome Measures

Primary Outcomes (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

  baseline, 6 week assessment

Secondary Outcomes (6)

• Health Related Quality of Life

  2 weeks

• Health Related Quality of Life

  6 weeks

• Total Sleep Time

  baseline, 6 weeks

• Control of Nocturnal Hypoventilation

  2 weeks

• Exercise Capacity

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

AVAPS-AE

Device: AVAPS-AE

Usual care

ACTIVE COMPARATOR

Non-invasive ventilation

Device: Usual care

Interventions

AVAPS-AE DEVICE

Novel ventilation mode (Omnilab - AVAPS AE algorithm)

Intervention

Usual care DEVICE

Non-invasive ventilation with standard ventilator

Usual care

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Patrick Murphy: lead
• Philips Respironics: collaborator

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Non-randomised controlled study

Results Point of Contact

• Title: Gill Arbane, Clinical trials coordinator
• Organization: GSTT

gill.arbane@gstt.nhs.uk

02071888070

Study Officials

• Nicholas Hart

  GSTT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 18, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 18, 2016
• Results First Posted: August 18, 2016

Record last verified: 2016-07

Locations

GB (1)