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Home Mechanical Ventilation vs Home Oxygen Therapy in COPD

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ClinicalTrials.gov Identifier: NCT00990132
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : May 13, 2016
Guy's & St Thomas' Charity
Respironics International
ResMed Foundation
Information provided by (Responsible Party):
Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust

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).

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Home mechanical ventilation Device: Long term oxygen therapy Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
Study Start Date : October 2009
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: Long term oxygen therapy
LTOT will be established as per current national guidelines
Device: Long term oxygen therapy
LTOT established as per national guidelines

Experimental: Home mechanical ventilation
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
Nocturnal non-invasive ventilation
Other Names:
  • Harmony 2

Primary Outcome Measures :
  1. Days from trial intervention to either hospital admission or death [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Spirometry - specifically FEV1 & FVC change from trial intervention to follow up. [ Time Frame: 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 [ Time Frame: 1 year ]
  3. Change in arterial PaCO2 from pre-intervention to follow up [ Time Frame: 1 year ]
  4. Change in the incremental shuttle walk test from pre-intervention to follow up [ Time Frame: 1 year ]
  5. Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00990132

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United Kingdom
Papworth Hospital
Cambridge, United Kingdom
St James' University Hospital
Leeds, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
King's College Hospital
London, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom
Royal Free Hospital / University College London
London, United Kingdom
John Radcliffe Hopsital
Oxford, United Kingdom
Sponsors and Collaborators
Patrick Murphy
Guy's & St Thomas' Charity
Respironics International
ResMed Foundation
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Principal Investigator: Patrick Murphy, MBBS Guy's and St Thomas' NHS Foundation Trust
Study Chair: Nicholas Hart, PhD Guy's and St Thomas' NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick Murphy, PI, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00990132    
Other Study ID Numbers: RJ1 09/N070
First Posted: October 6, 2009    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust:
Respiratory failure
Non-invasive ventilation
Home mechanical ventilation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases