Condition category
Respiratory
Date applied
18/02/2019
Date assigned
19/02/2019
Last edited
22/03/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the UK. COPD patients suffer with episodes of worsening breathing symptoms called exacerbations. Exacerbations occur more often as the disease progresses and are a leading cause of emergency hospitalisation. Patients recovering from exacerbations are at high risk of deteriorating, with one quarter readmitted to hospital within 30 days. COPD thus imposes immense burdens on the National Health Service and patients. This study will investigate the effects of using humidified nasal high-flow (HNHF) during recovery from severe COPD exacerbations. HNHF delivers warmed, humidified air under flows of up to 60 litres per minute through a nasal interface. This has been shown to improve clinical outcomes, including exacerbation frequency, hospitalisations, breathlessness and quality of life amongst COPD patients with respiratory failure. It is thought to achieve this by improving secretion clearance and providing positive airways pressure which supports the breathing system.

Who can participate?
Patients admitted to St Thomas’ Hospital, London with COPD exacerbations

What does the study involve?
Before discharge, participants are randomly allocated to receive either usual care alone or usual care plus a HNHF device, which they are trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics. Participants are followed up for 30 days after hospital discharge using weekly assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical activity. This enables evaluation of the clinical effects of HNHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage is also measured. Participants who receive devices are interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants undergoes detailed breathing tests during and after exercise to explore the effects of HNHF on the respiratory system.

What are the possible benefits and risks of participating?
It is known that HNHF reduces frequency of hospital admissions and exacerbations and improves symptoms and quality of life in stable COPD patients. This study investigates whether it also has these beneficial effects in COPD patients recovering from severe exacerbations. There are no reported adverse side effects of using the device.

Where is the study run from?
Guy’s and St Thomas’ NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2018 to August 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Prof. Nicholas Hart
Nicholas.hart@gstt.nhs.uk
2. Dr Rebecca D’Cruz
Rebecca.DCruz@gstt.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nicholas Hart

ORCID ID

Contact details

Lane Fox Research Unit
St Thomas’ Hospital
Westminister Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)207 188 8070
Nicholas.hart@gstt.nhs.uk

Type

Scientific

Additional contact

Dr Rebecca D'Cruz

ORCID ID

http://orcid.org/0000-0001-5245-9911

Contact details

Lane Fox Research Unit
St Thomas’ Hospital
Westminister Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)207 188 8070
Rebecca.DCruz@gstt.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

40985

Study information

Scientific title

The role of nasal high-flow to reduce 30-day hospital readmissions following severe exacerbations of chronic obstructive pulmonary disease: a mixed-methods feasibility study

Acronym

NHF Post-AECOPD

Study hypothesis

The primary objective is to estimate the effects of humidified nasal high flow on clinical outcomes that are important to patients and healthcare services (30-day hospital readmission, re-exacerbation, breathlessness, health-related quality of life and physical activity), explore patients’ experiences of using the device and understand the effects it has on the breathing system during physical exertion.

Ethics approval

London – Harrow Research Ethics Committee, Bristol HRA Centre, Level 3, Block B Whitefriars, Lewins Mead, Bristol, BS1 2NT, Tel: +44 (0)2071048056, Email: nrescommittee.london-harrow@nhs.net, ref: 19/LO/0194 - approval pending

Study design

Randomised; Interventional; Design type: Treatment, Device

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Chronic obstructive pulmonary disease

Intervention

Patients admitted to St Thomas’ Hospital, London with COPD exacerbations will be recruited. Prior to discharge, participants will be randomised to receive either usual care alone or usual care plus a nasal high-flow (NHF) device, which they will be trained to use for a regular period daily. Usual care includes inhalers, steroids and may include antibiotics.

Participants will be followed up for 30 days after hospital discharge using weekly assessments, daily symptom diaries and wrist-worn watch-like devices that detect physical activity. This will enable evaluation of the clinical effects of NHF on re-exacerbations, readmissions, breathlessness, physical activity and quality of life. Device usage will also be quantified. Participants who receive devices will be interviewed to explore their experiences. After the 30-day home follow-up period, a sub-group of participants will undergo detailed breathing tests during and after exercise to explore the effects of NHF on the respiratory system.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Estimate of the standard deviation for and possible effect size of 30-day hospital readmission to inform the design of a Phase III multicentre RCT: measured using symptom diaries and medical records at weeks 1, 2, 3, 4 following hospital discharge

Secondary outcome measures

Current secondary outcome measures as of 22/03/2019:
Feasibility:
1. Recruitment rate of eligible patients, measured using the number of eligible patients consenting to participate in the study during the period of recruitment.
2. Adherence with completion of outcome measures, measured by reviewing adherence to the study protocol following completion of individual participants’ study completion
3. Participant’s NHF device usage, measured from the device following individual participants’ study completion

Clinical: obtaining estimates of standard deviations and possible effect size of:
1. Admission and non-admission re-exacerbation, measured using symptom diaries at weeks 1, 2, 3, 4
2. Breathlessness, measured daily using symptom diaries, modified Borg and VAS scores for 30 days following hospital discharge and weekly Multidimensional Dyspnoea Profile (MDP) in weeks 1, 2, 3, 4
3. Physical activity, measured continuously using wrist-worn physical activity monitors for the 30-day follow-up period
4. Health-related quality of life, measured using COPD Assessment Test and Clinical COPD Questionnaire at admission, discharge and weekly at weeks 1, 2, 3, 4
5. Lung function, measured using weekly measurements of spirometry at weeks 1, 2, 3, 4

Acceptability of NHF, assessed using qualitative evaluation – a semi-structured interview at week 4

Proof-of-concept sub-study:
1. Inspiratory capacity, measured during incremental exercise testing
2. Breathlessness, measured using mBorg score and MDP before, during and after exercise testing
3. Neural respiratory drive, measured continuously using electromyography during exercise testing
4. Pulmonary mechanics, including pulmonary pressures and flow, measured continuously using a pressure transducer and pneumotachograph during exercise testing
4. Time to recover from maximal breathlessness, measured with a timer, as time from maximal mBorg score to pre-exercise baseline score

Previous secondary outcome measures:
Feasibility:
1, Recruitment rate of eligible patients, measured using the number of eligible patients consenting to participate in the study during the period of recruitment.
2. Adherence with completion of outcome measures, measured by reviewing adherence to the study protocol (completion of all measured variables) following completion of individual participants’ study completion
3. Participant’s NHF device usage, measured directly from the device following individual participants’ study completion

Clinical: obtaining estimates of standard deviations and possible effect size of:
1. Non-admission re-exacerbation, measured using symptom diaries at weeks 1, 2, 3, 4
2. Breathlessness, measured daily using symptom diaries, modified Borg and VAS scores for 30 days following hospital discharge and weekly Multidimensional Dyspnoea Profile (MDP) in weeks 1, 2, 3, 4
3. Physical activity, measured continuously using wrist-worn physical activity monitors for the 30-day follow-up period
4. Health-related quality of life, measured using COPD Assessment Test, Clinical COPD Questionnaire at admission, discharge and weekly at weeks 1, 2, 3, 4
5. Lung function, measured using weekly measurements of spirometry at weeks 1, 2, 3, 4

Acceptability of NHF, assessed using qualitative evaluation – a semi-structured interview at week 4

Proof-of-concept sub-study:
1. Peak exercise capacity, measured using peak work during maximal exercise testing
2. Breathlessness, measured during mBorg score and MDP during exercise testing
3. Neural respiratory drive, measured continuously using electromyography during exercise testing
4. Time to recover from maximal breathlessness, measured with a timer, time from maximal mBorg score to pre-exercise baseline score

Overall trial start date

01/09/2018

Overall trial end date

01/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Emergency hospital admission with a primary diagnosis of AECOPD
2. Aged 40-80 years
3. > = 10 pack year smoking history
4. Body mass index < = 35kg/m2
5. Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol
6. To be discharged home following the hospitalisation in a home environment deemed safe by the investigator to perform home assessments
7. Patient lives in the catchment area served by the Integrated Respiratory Team at Guy’s and St Thomas’ NHS Foundation Trust

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Chest radiograph shows pneumothorax
2. Requirement for acute NIV during index hospitalisation or established on home PAP
3. Significant chronic respiratory failure (PaCO2 > 7.0)
4. Clinically significant obstructive sleep apnoea requiring treatment
5. Allergies to latex, metals or local anaesthetic
6. Broken or inflamed skin at the second intercostal space parasternal chest wall areas
7. Psychological or social factors that would impair compliance with the study protocol
8. Any major non-COPD chronic co-morbidity that may contribute significantly to risk of readmission, including (but not limited to) severe heart failure (left ventricular ejection fraction < 30%), malignancy (active treatment or palliation), end stage renal failure and significant neuromuscular disease
9. Planned travel away from home in the 30-day post-discharge period

Recruitment start date

01/04/2019

Recruitment end date

01/04/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy’s and St Thomas’ NHS Foundation Trust
St Thomas’ Hospital Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St Thomas' NHS Foundation Trust

Sponsor details

Trust Offices
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)2071887188
R&D@gstt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Academy; Grant Codes: DRF-2018-11-ST2-037

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study will be published in a high-impact factor peer-reviewed journal and will be presented at international conferences. A lay results summary will be provided to study participants upon study completion. The trialists do not plan to provide additional study documents.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/08/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/03/2019: The condition has been changed from "Specialty: Respiratory Disorders, Primary sub-specialty: Chronic Obstructive Pulmonary Disease; Health Category: Respiratory; Disease/Condition: Chronic lower respiratory diseases" to "Chronic obstructive pulmonary disease" following a request from the NIHR. 22/03/2019: The secondary outcome measures were updated. 21/02/2019: Contact details updated.