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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
Sponsor:
Collaborators:
Guy's & St Thomas' Charity
Respironics International
ResMed
ResMed Foundation
Information provided by (Responsible Party):
Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE October 5, 2009
First Posted Date  ICMJE October 6, 2009
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2009)
Days from trial intervention to either hospital admission or death [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
Admission free survival [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
  • Spirometry - specifically FEV1 & FVC change from trial intervention to follow up. [ Time Frame: 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 [ Time Frame: 1 year ]
  • Change in arterial PaCO2 from pre-intervention to follow up [ Time Frame: 1 year ]
  • Change in the incremental shuttle walk test from pre-intervention to follow up [ Time Frame: 1 year ]
  • Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • Exacerbation frequency [ Time Frame: 1 year ]
  • Spirometry [ Time Frame: 1 year ]
  • Health related quality of life (SRI/CRDQ/MRC) [ Time Frame: 1 year ]
  • PaCO2 [ Time Frame: 1 year ]
  • Incremental shuttle walk test [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home Mechanical Ventilation vs Home Oxygen Therapy in COPD
Official Title  ICMJE Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Device: Home mechanical ventilation
    Nocturnal non-invasive ventilation
    Other Names:
    • Harmony 2
    • VPAP III STA
  • Device: Long term oxygen therapy
    LTOT established as per national guidelines
Study Arms  ICMJE
  • Active Comparator: Long term oxygen therapy
    LTOT will be established as per current national guidelines
    Intervention: Device: Long term oxygen therapy
  • 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.
    Intervention: Device: Home mechanical ventilation
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2009)
116
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00990132
Other Study ID Numbers  ICMJE RJ1 09/N070
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust
Study Sponsor  ICMJE Patrick Murphy
Collaborators  ICMJE
  • Guy's & St Thomas' Charity
  • Respironics International
  • ResMed
  • ResMed Foundation
Investigators  ICMJE
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
PRS Account Guy's and St Thomas' NHS Foundation Trust
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP