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Chronic Obstructive Pulmonary DiseasePhase 2/3NCT00990132

Home Mechanical Ventilation vs Home Oxygen Therapy in COPD

A Phase 2/3 study testing Home mechanical ventilation and Long term oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by Patrick Murphy at 7 sites 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Home mechanical ventilation and Long term oxygen therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
7 sitesUnited Kingdom
Study dates
Oct 2009to Apr 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United Kingdom7 sites

  • Papworth Hospital

    Cambridge

  • St James' University Hospital

    Leeds

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH

  • King's College Hospital

    London

  • Royal Brompton & Harefield NHS Foundation Trust

    London

  • Royal Free Hospital / University College London

    London

  • John Radcliffe Hopsital

    Oxford

Other trials in United Kingdom

About this study

Official title: Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation

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).

Read the detailed description

Although HMV has been shown to improve physiological parameters as well as have clinical benefits in terms of dyspnoea and exercise capacity in severe COPD, the published randomised controlled trials have been less positive. The Steering Committee are committed to design a robust clinical trial that will answer this clinical question. Therefore, a multi-centre randomised controlled trial has been designed with recruitment and power calculations based on the applicants own data.

We will recruit from 8 UK university centres with expertise in HMV, 116 hypercapnic patients (58 in each arm) with persistent hypercapnia following an episode of acute hypercapnic respiratory failure. During the acute hypercapnic episode the patient would have be eligible for non-invasive ventilation with a pH <7.35 and a partial pressure of carbon dioxide (PaCO2) > 7.0kPa. They will be randomised, for a 12 months, to either

  1. HMV and LTOT (Treatment Group)
  2. LTOT alone (Control Group) This study would allow the investigators to answer a number of questions pertaining to clinical efficacy of HMV in COPD as well as the mechanism of action of HMV in COPD
  • Does HMV effect admission-free survival?
  • Does HMV reduce exacerbation frequency?
  • Does HMV impact on disease progression?
  • Does HMV improve health-related quality of life?
  • Does HMV improve exercise capacity?
  • Is there a dose-response between hours of ventilator compliance and daytime PaO2 and PaCO2?
  • Do patients increase hours of ventilator use during acute exacerbations?
  • Is ventilator compliance with HMV and LTOT acceptable?
  • Does HMV reduce healthcare utilisation? Follow-up assessments will be performed at 6 weeks, 3, 6 and 12 months. These data collected will include admission-free survival (primary outcome), hours of compliance with HMV, HRQL, gas exchange, lung function, body composition, exercise capacity, exacerbation frequency primary care consultations and compliance with LTOT, time to withdrawal of LTOT/night-time oxygen therapy based on daytime PaO2 and overnight SaO2 (secondary outcome measures). The relation of any changes to factors predicting severity of COPD will be studied. The cost effectiveness and cost-utility analysis of HMV will be studied.
Being tested
Home mechanical ventilation, Long term oxygen therapy
Keywords
COPD, Respiratory failure, Non-invasive ventilation, Home mechanical ventilation
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.

  • Home mechanical ventilationDevice

    Also called Harmony 2, VPAP III STA

    Nocturnal non-invasive ventilation

  • Long term oxygen therapyDevice

    LTOT established as per national guidelines

Study groups in NCT00990132
Study groupRoleWhat they receive
Long term oxygen therapyActive comparatorLTOT will be established as per current national guidelines
Receives: Device: Long term oxygen therapy
Home mechanical ventilationExperimentalPatients will be set up on LTOT as per national guidelines and nocturnal non-invasive ventilation in accordance with study protocol.
Receives: Device: Home mechanical ventilation

What is being measured

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

  1. Days from trial intervention to either hospital admission or death

    Measured: 1 year

Secondary outcomes (5)

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

    Measured: 1 year

  2. 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

    Measured: 1 year

  3. Change in arterial PaCO2 from pre-intervention to follow up

    Measured: 1 year

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

    Measured: 1 year

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

    Measured: 1 year

Timeline

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

  1. First posted6 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2016
  4. Study completionApr 2016

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00990132
Sponsor's protocol ID
RJ1 09/N070
Status last verified
May 2016
First submitted
5 Oct 2009
Last updated
13 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36823164

  • 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.

    PubMed 28528348

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Home mechanical ventilation and Long term oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by Patrick Murphy at 7 sites 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 8 inclusion and 14 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Days from trial intervention to either hospital admission or death (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00990132, which also lists 2 linked publications.

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 13 May 2016.

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