- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00990132
Home Mechanical Ventilation vs Home Oxygen Therapy in COPD
Randomised Controlled Trial of Home Mechanical Ventilation in Hypercapnic Chronic Obstructive Pulmonary Disease Patients Post Acute Hypercapnic Exacerbation
Study Overview
Status
Conditions
Intervention / Treatment
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
- HMV and LTOT (Treatment Group)
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Cambridge, United Kingdom
- Papworth Hospital
-
Leeds, United Kingdom
- St James' University Hospital
-
London, United Kingdom
- King's College Hospital
-
London, United Kingdom, SE1 7EH
- Guy's & St Thomas' NHS Foundation Trust
-
London, United Kingdom
- Royal Brompton & Harefield NHS Foundation Trust
-
London, United Kingdom
- Royal Free Hospital / University College London
-
Oxford, United Kingdom
- John Radcliffe Hopsital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Long term oxygen therapy
LTOT will be established as per current national guidelines
|
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.
|
Nocturnal non-invasive ventilation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Days from trial intervention to either hospital admission or death
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spirometry - specifically FEV1 & FVC change from trial intervention to follow up.
Time Frame: 1 year
|
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
|
1 year
|
Change in arterial PaCO2 from pre-intervention to follow up
Time Frame: 1 year
|
1 year
|
Change in the incremental shuttle walk test from pre-intervention to follow up
Time Frame: 1 year
|
1 year
|
Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ1 09/N070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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