Chronic Obstructive Pulmonary Disease SevereNCT04848012
Efficacy of an Advanced Auto-titrating NIV in COPD
A study testing Auto-titrating non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease Severe, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe
- What is being tested?
- Auto-titrating non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2021to 20 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
- Presence of major medical comorbidity, e.g. severe heart failure (LVEF <30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
- Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Psychosocial factors that would prevent compliance with study protocol
- Healthy participant inclusion criteria:
- Age ≥ 18 years
Show all 9Show fewer
- No expiratory flow limitation on forced oscillation testing
- No acute illness on study day
- Ability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guys and St Thomas NHS Foundation Trust
London, London, SE1 7EH
About this study
Official title: Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease
Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.
Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.
Read more
The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.
Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.
Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.
- Being tested
- Auto-titrating non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-titrating non-invasive ventilationDevice
A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.
| Study group | Role | What they receive |
|---|---|---|
| Usual non-invasive ventilation | No intervention | The usual therapy the participant is receiving via non-invasive ventilator. |
| Auto-titrating non-invasive ventilation | Experimental | A novel auto-titrating non-invasive ventilator Receives: Device: Auto-titrating non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to ventilation therapy
Number of hours spent on nocturnal ventilation therapy
Measured: 6 weeks
Secondary outcomes (11)
Mean nocturnal transcutaneous carbon dioxide level
Mean nocturnal transcutaneous carbon dioxide level measured on single night admission
Measured: 1 night during single night admission
Maximal nocturnal transcutaneous carbon dioxide level
Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission
Measured: 1 night during single night admission
Sleep parameters
Sleep efficiency, measured by polysomnography
Measured: 1 night during single night admission
Sleep parameters
Wake after sleep onset, measured by polysomnography
Measured: 1 night during single night admission
Sleep parameters
Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography
Measured: 1 night during single night admission
Sleep parameters
Apnoea/hypopnoea index, measured by polysomnography
Measured: 1 night during single night admission
Sleep parameters
4 per cent oxygen desaturation index, measured by polysomnography
Measured: 1 night during single night admission
Inspiratory capacity
Inspiratory capacity following 6 weeks of each NIV device
Measured: 6 weeks
Health-related quality of life
Measured using COPD Assessment Test
Measured: 6 weeks
Health-related quality of life
Measured using Severe Respiratory Insufficiency Questionnaire
Measured: 6 weeks
Daytime physical activity
Measured using wrist actigraphs during the final 2 weeks of each 6 week arm
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start4 May 2021
- Primary completion12 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 12 weeks sequential (pre/post) study. Participants will receive usual NIV treatment for 6 weeks followed by novel ventilator for 6 weeks. There will be a randomised crossover element for one night at the midpoint of the study to assess sleep parameters on the two ventilation modalities.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 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
- Neeraj Shah, Principal investigator, Guy's and St Thomas' NHS Foundation TrustNicholas Hart, Study chair, Guy's and St Thomas' NHS Foundation TrustPatrick Murphy, Study director, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848012
- Sponsor's protocol ID
- 279564
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04848012
- Acronym / sponsor ID
- 279564
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 19 Apr 2021 (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.
Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.
Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.
The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.
Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.
Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 12 weeks sequential (pre/post) study. Participants will receive usual NIV treatment for 6 weeks followed by novel ventilator for 6 weeks. There will be a randomised crossover element for one night at the midpoint of the study to assess sleep parameters on the two ventilation modalities.
| Arm | Type | Receives |
|---|---|---|
| Usual non-invasive ventilation | No intervention | –The usual therapy the participant is receiving via non-invasive ventilator. |
| Auto-titrating non-invasive ventilation | Experimental | Device: Auto-titrating non-invasive ventilationA novel auto-titrating non-invasive ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
- Presence of major medical comorbidity, e.g. severe heart failure (LVEF <30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
- Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Psychosocial factors that would prevent compliance with study protocol
- Age ≥ 18 years
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 |
|---|---|---|
| Auto-titrating non-invasive ventilationA non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique. | Device | Auto-titrating non-invasive ventilation |
Primary outcome
Adherence to ventilation therapy
Time frame: 6 weeks
Number of hours spent on nocturnal ventilation therapy
11 secondary outcomes
Mean nocturnal transcutaneous carbon dioxide level
Time frame: 1 night during single night admission
Maximal nocturnal transcutaneous carbon dioxide level
Time frame: 1 night during single night admission
Sleep parameters
Time frame: 1 night during single night admission
Sleep parameters
Time frame: 1 night during single night admission
Sleep parameters
Time frame: 1 night during single night admission
Sleep parameters
Time frame: 1 night during single night admission
Sleep parameters
Time frame: 1 night during single night admission
Inspiratory capacity
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Daytime physical activity
Time frame: 2 weeks
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 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease Severe
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis
Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
RecruitingPhase 3
Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)
Pulmonary Disease, Chronic Obstructive
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Neeraj Shah principal investigator
Guy's and St Thomas' NHS Foundation Trust
Nicholas Hart study chair
Guy's and St Thomas' NHS Foundation Trust
Patrick Murphy study director
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 Auto-titrating non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease Severe, 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 0 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 4 Jun 2026. 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?
Adherence to ventilation therapy (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.