Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a collection of lung diseases usually caused by smoking. When symptoms become particularly bad this is called an exacerbation. Some exacerbations of COPD can be very severe and patients need support from breathing machines (ventilators) in addition to oxygen therapy. Previous studies have examined whether the use of a ventilator at home, termed home mechanical ventilation, could help improve people’s breathing and reduce the need for readmission to hospital, but these studied have not been able to demonstrate a benefit. This is thought to be due to the poor design of the studies rather than failure of the ventilator itself. This study is a UK-wide study to investigate if home mechanical ventilation in addition to home oxygen therapy is better than home oxygen therapy on its own.
Who can participate?
Patients aged 18 or older who have had a life-threatening COPD exacerbation at least 2 weeks ago
What does the study involve?
Participants are randomly allocated to receive home oxygen therapy with or without home mechanical ventilation. They are followed up for 12 months to see if patients who received home mechanical ventilation have fewer hospital admissions.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
St Thomas's Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2009 to June 2016
Who is funding the study?
1. Guy's and St. Thomas' Charity (UK)
2. Respironics, Inc. (USA)
3. ResMed Ltd (Australia)
Who is the main contact?
Dr Patrick Murphy
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00990132
Protocol/serial number
8059
Study information
Scientific title
Randomised controlled trial of home mechanical ventilation in hypercapnic chronic obstructive pulmonary disease patients post acute hypercapnic exacerbation
Acronym
HOT HMV in COPD
Study hypothesis
The trial is designed to test the hypothesis that the use of home non-invasive ventilation (NIV) in persistently hypercapnic chronic obstructive pulmonary disease (COPD) patients following an acute hypercapnic exacerbation of COPD reduces hospital admissions and improves survival.
Ethics approval
St Thomas' Hospital Research Ethics Committee, 12/06/2009, ref: 09/H0802/2
Study design
Randomised interventional multicentre treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Respiratory; Subtopic: Respiratory (all Subtopics); Disease: Respiratory
Intervention
1. Domiciliary non-invasive ventilation (HMV)
2. Home oxygen therapy (HOT)
Follow up length: 12 month(s)
Study entry: Single randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Admission-free survival up to 12 months
Secondary outcome measures
Measured at 6 weeks, 3 months, 6 months, 12 months:
1. Daily activity - actigraphy
2. Exercise tolerance
3. Pulmonary mechanics
4. Respiratory muscle strength
5. Sleep quality - actigraphy
Overall trial start date
01/10/2009
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Acute hypercapnic exacerbation of COPD at least 2 weeks previously
2. In patient admission with acute hypercapnic respiratory failure
3. Smoking greater than 20 pack year history
4. Forced expiratory volume in one second (FEV1) less than 50%
5. FEV1/forced vital capacity (FVC) less than 60%
6. Chronic hypercapnia (PaCO2 greater than 7 kPa)
7. Chronic hypoxia PaO2 less than 7.3 kPa or less than 8 kPa with secondary polycythaemia, pulmonary hypertension, peripheral oedema or significant nocturnal hypoxia (SpO2 less than 90% for greater than 30% sleep time)
8. Aged 18 years or older, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 116; UK Sample Size: 116
Participant exclusion criteria
1. Unable to wean off NIV prior to discharge (persistent hypercapnic respiratory failure with pH less than 7.30)
2. Post extubation or decanulation
3. Body mass index (BMI) greater than 35 kg/m^2
4. Primary diagnosis of restrictive lung disease causing hypercapnia
5. Development of worsening hypercapnic respiratory failure with acidosis during initiation of oxygen therapy (ABG - pH less than 7.30 taken 2 - 4 hours after waking)
6. Unable to tolerate NIV (if given) during acute illness
7. Unstable coronary artery syndrome
8. Renal replacement therapy
9. Inability to consent/comply with trial protocol (as determined by site PI)
10. Aged less than 18 years
11. Pregnant
Recruitment start date
01/02/2010
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas's Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
Guy's and St. Thomas' NHS Foundation Trust (UK)
Sponsor details
4th Floor
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Guy's and St. Thomas' Charity (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Respironics, Inc. (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
ResMed Ltd (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study will be analysed and prepared for publication in a scientific journal and presentation at international conferences such as the European respiratory congress.
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to institution policy.
Intention to publish date
30/06/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28528348