NCT00990132

Brief Summary

This study is designed to investigate the effect of home mechanical ventilation (HMV) in patients with severe chronic obstructive pulmonary disease (COPD). The purpose of the trial is to test the hypothesis that HMV and longterm oxygen therapy (LTOT) increases admission free survival compared with LTOT alone. More specifically, compared with LTOT, HMV and LTOT reduces hospital re-admission in COPD patients who remain persistently hypercapnic following an acute exacerbation requiring non-invasive ventilation (NIV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

6.5 years

First QC Date

October 5, 2009

Last Update Submit

May 11, 2016

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDRespiratory failureNon-invasive ventilationHome mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Days from trial intervention to either hospital admission or death

    1 year

Secondary Outcomes (5)

  • Spirometry - specifically FEV1 & FVC change from trial intervention to follow up.

    1 year

  • Changes Health related quality of life from pre-intervention to follow up - specifically outcomes of severe respiratory insufficiency questionnaire, chronic respiratory disease questionnaire & MRC dyspnoea score

    1 year

  • Change in arterial PaCO2 from pre-intervention to follow up

    1 year

  • Change in the incremental shuttle walk test from pre-intervention to follow up

    1 year

  • Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission

    1 year

Study Arms (2)

Long term oxygen therapy

ACTIVE COMPARATOR

LTOT will be established as per current national guidelines

Device: Long term oxygen therapy

Home mechanical ventilation

EXPERIMENTAL

Patients will be set up on LTOT as per national guidelines and nocturnal non-invasive ventilation in accordance with study protocol.

Device: Home mechanical ventilation

Interventions

Home mechanical ventilationDEVICE

Nocturnal non-invasive ventilation

Also known as: Harmony 2, VPAP III STA
Home mechanical ventilation
Long term oxygen therapyDEVICE

LTOT established as per national guidelines

Long term oxygen therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD
  • Acute hypercapnic exacerbation of COPD at least 2 weeks previously
  • Tolerated non-invasive ventilation during acute hypercapnic exacerbation
  • Chronic hypoxia requiring LTOT (PaO2 \<7.3kPa or a PaO2 \>7.3 and \<8.0kPa and one of the following: secondary polycythaemia; nocturnal hypoxaemia SaO2 \<90% for \>30% of the time; peripheral oedema; or PHT)
  • Chronic hypercapnia (PaCO2 \>7kPa)
  • ≥20 pack year smoking history
  • FEV1/FVC \<60%
  • FEV1 at \<50% predicted

You may not qualify if:

  • Persistent hypercapnic respiratory failure with acidosis (defined as pH \<7.30 after bronchodilators)
  • Development of worsening hypercapnic respiratory failure with acidosis during initiation of LTOT therapy
  • Failure to tolerate NIV during the acute illness preceding trial identification
  • Post extubation or decannulation following AHRF requiring intubation
  • Restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the FEV1/FVC ratio is \<60% and the FEV1 \<50% if the predominant defect is considered to be obstructive by the center clinician.
  • Clinical features of severe OSA
  • BMI \>35kg/m2
  • Unstable coronary artery syndrome
  • Cognitive impairment that would prevent informed consent into the trial
  • Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge
  • Patients undergoing renal replacement therapy
  • Age \<18 years
  • Pregnant
  • Inability to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Papworth Hospital

Cambridge, United Kingdom

Location

St James' University Hospital

Leeds, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Location

Royal Free Hospital / University College London

London, United Kingdom

Location

John Radcliffe Hopsital

Oxford, United Kingdom

Location

Related Publications (2)

  • Murphy PB, Brueggenjuergen B, Reinhold T, Gu Q, Fusfeld L, Criner G, Goss TF, Hart N. Cost-effectiveness of home non-invasive ventilation in patients with persistent hypercapnia after an acute exacerbation of COPD in the UK. Thorax. 2023 May;78(5):523-525. doi: 10.1136/thorax-2022-219653. Epub 2023 Feb 23.

    PMID: 36823164DERIVED

  • Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.

    PMID: 28528348DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveRespiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration Disorders

Study Officials

  • Patrick Murphy, MBBS

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Nicholas Hart, PhD

    Guy's and St Thomas' NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

GB(7)