Condition category
Respiratory
Date applied
31/03/2010
Date assigned
31/03/2010
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Patrick Murphy

ORCID ID

Contact details

St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom

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 below 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 measures

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

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

http://www.guysandstthomas.nhs.uk/

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. Patient data not available without request and appropriate ethical review.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/08/2016: the following changed were made to the trial record: 1. The overall trial end date was changed from 30/09/2010 to 30/06/2016. 2. Plain English summary added.