Chronic Obstructive Pulmonary DiseaseNCT03899558
The Role of HNHF to Improve Clinical Outcomes Following Severe AECOPD
A study testing Humidified nasal high-flow device in people with Chronic Obstructive Pulmonary Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Humidified nasal high-flow device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jun 2019to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency hospital admission with a primary diagnosis of AECOPD
- Aged 40-80 years
- ≥10 pack year smoking history
- Body mass index ≤ 35kg/m2
- Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol
- To be discharged home following the hospitalisation in a home environment deemed safe by the investigator to perform home assessments
- Patient lives in the catchment area served by the Integrated Respiratory Team at Guy's and St Thomas' NHS Foundation Trust
Who cannot join
- Chest radiograph excludes pneumothorax
- Requirement for acute non-invasive ventilation (NIV) during index hospitalisation or established on home positive airway pressure (PAP)
- Significant chronic respiratory failure (PaCO2 >7.0)
- Clinically significant obstructive sleep apnoea requiring treatment
- Allergies to latex, metals or local anaesthetic
- Broken or inflamed skin at the second intercostal space parasternal chest wall areas
Show all 9Show fewer
- Psychological or social factors that would impair compliance with the study protocol
- 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
- Planned travel away from home in the 30-day post-discharge period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Official title: The Role of Humidified Nasal High-flow to Reduce 30-day Hospital Re-admissions Following Severe Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed Methods Feasibility Study
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). 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 thirty days. COPD thus imposes immense burdens on the National Health Service and patients.
This research 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.
Read more
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 HNHF 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 HNHF 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 HNHF on the respiratory system.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Humidified nasal high-flow device
- Keywords
- Neural respiratory drive, Physiology, Respiratory muscles, COPD exacerbation, Ventilation, Nasal high-flow, High-flow nasal cannula
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified nasal high-flow deviceDevice
Humidified nasal high-flow device which delivers warmed, humidified air at flow rates of up to 60 litres per minute via a nasal cannula interface. Intended delivery at 30 L/min at 37 degrees Celsius, if tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | HNHF device (intervention) + usual care Receives: Device: Humidified nasal high-flow device |
| Control | No intervention | Usual care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 30-day hospital readmission following index hospitalisation with AECOPD
30-day readmission
Measured: 30 days following hospital discharge
Secondary outcomes (17)
Recruitment rate of eligible patients
Feasibility outcome measure: assessed by proportion of patients who fulfil eligibility criteria who consent to participate.
Measured: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (symptom diary)
Feasibility outcome measure: assessed by completion of symptom diaries. Progression criterion = participant diaries completed by >70% of participants. Assessed at 30-days following hospital discharge.
Measured: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (physical activity monitor)
Feasibility outcome measure: assessed by usage of physical activity monitors. Progression criterion = usage >70% of participants. Measured from physical activity monitor computer downloads at 30-days following hospital discharge.
Measured: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (spirometry)
Feasibility outcome measure: assessed by completion of spirometry. Progression criterion = spirometry measured at every study assessment for >70% of participants.
Measured: 30 days following hospital discharge
Participants' HNHF device usage
Feasibility outcome measure: usage hours accessed from the device at completion of participants' study participation for those participants allocated to the intervention arm.
Measured: 30 days following hospital discharge
Acceptability of HNHF at home: semi-structured interviews
Qualitative evaluation: Use of semi-structured interviews after 30 days post-discharge following index hospitalisation to explore barriers and facilitators to device usage in intervention arm participants.
Measured: 30 days following hospital discharge
Non-readmission AECOPD
Clinical outcome measure: the number of acute exacerbations of COPD that do not require hospitalisation will be recorded using symptom diaries.
Measured: 30 days following hospital discharge
Breathlessness
Clinical outcome measure: breathlessness severity will be assessed using the modified Borg scale (minimum score = 0, indicating no breathlessness, maximum score = 10 indicating maximal intensity of breathlessness).
Measured: 30 days following hospital discharge
Breathlessness
Clinical outcome measure: breathlessness severity will be assessed using the Multidimensional Dyspnoea Profile.
Measured: 30 days following hospital discharge
Physical activity
Clinical outcome measure: daily physical activity (measured in counts per minute) will be quantified using a wrist-worn physical activity monitor which uses a triaxial accelerometer.
Measured: 30 days following hospital discharge
Health-related quality of life: COPD Assessment Test
Clinical outcome measure: assessed using the COPD Assessment Test.
Measured: 30 days following hospital discharge
Health-related quality of life: Clinical COPD Questionnaire
Clinical outcome measure: assessed using the Clinical COPD Questionnaire. Scored from 0 to 60, with higher scores indicative of worse disease-specific health-related quality of life.
Measured: 30 days following hospital discharge
Inspiratory capacity
Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a pneumotachograph.
Measured: 30 days following hospital discharge
Breathlessness
Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using the modified Borg scale. This zero to ten scale measures breathlessness intensity, with higher scores representing more intense breathlessness. The score will be measured before exercise, at 2 minute intervals during exercise, at exercise cessation and during exercise recovery.
Measured: 30 days following hospital discharge
Neural respiratory drive
Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a parasternal and diaphragm electromyography using surface and nasogastric electrodes, respectively.
Measured: 30 days following hospital discharge
Pulmonary pressures and flow
Proof of concept study outcome: measured during the physiological sub-study involving incremental exercise using a pressure transducer connected to a nasogastric catheter and a pneumotachograph.
Measured: 30 days following hospital discharge
Time to recover from maximal breathlessness
Proof of concept study outcome: time from maximal breathlessness at peak exercise to pre-exercise modified Borg scale.
Measured: 30 days following hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start17 Jun 2019
- Primary completion24 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Hart, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899558
- Sponsor's protocol ID
- 242147
- Status last verified
- Feb 2021
- First submitted
- 21 Mar 2019
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.
PubMed 26194996Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19.
PubMed 21597112
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Humidified Nasal High-flow to Reduce 30-day Hospital Re-admissions Following Severe Exacerbations of Chronic Obstructive Pulmonary Disease: a Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT03899558
- Acronym / sponsor ID
- 242147
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Neural respiratory drive, Physiology, Respiratory muscles, COPD exacerbation, Ventilation, Nasal high-flow, High-flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 24 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic Obstructive Pulmonary Disease (COPD) is a common lung disease, affecting 1.2 million people in the United Kingdom (UK). COPD patients suffer with episodes of worsening breathing symptoms called acute exacerbations (AECOPD). 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 thirty days. COPD thus imposes immense burdens on the National Health Service and patients.
This research 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.
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 HNHF 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 HNHF 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 HNHF on the respiratory system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Humidified nasal high-flow deviceHNHF device (intervention) + usual care |
| Control | No intervention | –Usual care alone |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Emergency hospital admission with a primary diagnosis of AECOPD
- Aged 40-80 years
- ≥10 pack year smoking history
- Body mass index ≤ 35kg/m2
- Cognitively and linguistically able to follow English instructions, provide informed consent and complete the study protocol
Key exclusion criteria (9 listed)
- Chest radiograph excludes pneumothorax
- Requirement for acute non-invasive ventilation (NIV) during index hospitalisation or established on home positive airway pressure (PAP)
- Significant chronic respiratory failure (PaCO2 >7.0)
- Clinically significant obstructive sleep apnoea requiring treatment
- Allergies to latex, metals or local anaesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humidified nasal high-flow deviceHumidified nasal high-flow device which delivers warmed, humidified air at flow rates of up to 60 litres per minute via a nasal cannula interface. Intended delivery at 30 L/min at 37 degrees Celsius, if tolerated. | Device | Intervention |
Primary outcome
Time to 30-day hospital readmission following index hospitalisation with AECOPD
Time frame: 30 days following hospital discharge
30-day readmission
17 secondary outcomes
Recruitment rate of eligible patients
Time frame: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (symptom diary)
Time frame: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (physical activity monitor)
Time frame: 30 days following hospital discharge
Adherence with completion of clinical outcome measures (spirometry)
Time frame: 30 days following hospital discharge
Participants' HNHF device usage
Time frame: 30 days following hospital discharge
Acceptability of HNHF at home: semi-structured interviews
Time frame: 30 days following hospital discharge
Non-readmission AECOPD
Time frame: 30 days following hospital discharge
Breathlessness
Time frame: 30 days following hospital discharge
Breathlessness
Time frame: 30 days following hospital discharge
Physical activity
Time frame: 30 days following hospital discharge
Health-related quality of life: COPD Assessment Test
Time frame: 30 days following hospital discharge
Health-related quality of life: Clinical COPD Questionnaire
Time frame: 30 days following hospital discharge
Inspiratory capacity
Time frame: 30 days following hospital discharge
Breathlessness
Time frame: 30 days following hospital discharge
Neural respiratory drive
Time frame: 30 days following hospital discharge
Pulmonary pressures and flow
Time frame: 30 days following hospital discharge
Time to recover from maximal breathlessness
Time frame: 30 days following hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 26194996Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.
- Background: PubMed 21597112Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Hart, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidified nasal high-flow device in people with Chronic Obstructive Pulmonary Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 30-day hospital readmission following index hospitalisation with AECOPD (time frame: 30 days following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.