COPD (Chronic Obstructive Pulmonary Disease)VMN-NIVNCT06884228
Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)
A study testing Vibrating mesh nebulisation and Jet nebuliser in people with COPD (Chronic Obstructive Pulmonary Disease) and Non-invasive Ventilation, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on the electrical activity of the muscles involved in breathing (neural respiratory drive), breathing mechanics (respiratory impedance measured by forced oscillation technique), respiratory flow, heart rate and rhythm, spirometry and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Non-invasive Ventilation
- What is being tested?
- Vibrating mesh nebulisation and Jet nebuliser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Apr 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD receiving home non-invasive ventilation for chronic respiratory failure under the Lane Fox Respiratory Service at Guy's and St Thomas' NHS Foundation Trust
- Tolerating home non-invasive ventilation for at least 4 hours/24 hours
- Aged 18-80 years old
- Able to communicate symptom burden to the research team
- Able to give informed consent for participation in the study
- Clinical stability, with no acute exacerbations of COPD for 2 weeks prior to enrolment
Who cannot join
- Severe, non-respiratory organ dysfunction including, but not limited to:
- Congestive cardiac failure
- Significant cardiovascular disease
- End-stage malignancy
- End-stage renal failure
- Acute pulmonary pathology requiring emergency treatment including, but not limited to:
Show all 11Show fewer
- Pneumonia
- Pneumothorax
- Pulmonary embolism
- Severe cognitive impairment
- Psychosocial factors that would preclude completion of the study protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lane Fox Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on the electrical activity of the muscles involved in breathing (neural respiratory drive), breathing mechanics (respiratory impedance measured by forced oscillation technique), respiratory flow, heart rate and rhythm, spirometry and breathlessness symptoms in patients with chronic obstructive pulmonary disease who require non-invasive ventilation.
Read the detailed description
Background Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality in the United Kingdom. Acute exacerbations of COPD (AECOPD) frequently necessitate hospitalisation, with standard treatment comprising nebulised bronchodilators, antibiotics, and systemic corticosteroids. Approximately 20% of patients hospitalised with AECOPD require non-invasive ventilation (NIV) to manage decompensated hypercapnic respiratory failure, often necessitating concurrent administration of nebulised therapy.
Home NIV use is increasing among COPD patients to improve respiratory symptoms, quality of life, reduce hospitalisation frequency, and enhance survival. These patients may also require nebulised bronchodilator therapy during NIV, particularly when managing acute exacerbations not severe enough to warrant hospitalisation.
Currently, two nebulisation modalities are used as standard of care for patients on NIV:
Jet nebulisation (JN) - the conventional delivery method Vibrating mesh nebulisation (VMN) - a newer technology that utilises a mesh membrane oscillating at high frequency to produce drug-carrying droplets of predetermined size
VMN has been developed to optimise drug delivery in various patient populations, including those who are spontaneously breathing, receiving invasive mechanical ventilation, or on NIV. This technology is designed to enhance pulmonary drug deposition while minimising residual drug volume post-nebulisation.
Previous research has demonstrated that VMN achieves superior pulmonary drug deposition during NIV compared to JN in both healthy subjects and stable COPD patients. VMN has also been shown to produce greater improvements in forced expiratory volume in one second (FEV₁) among hospitalised patients. However, the comparative effects of these nebulisation methods on physiological parameters such as neural respiratory drive and respiratory system impedance during NIV in COPD patients with chronic respiratory failure remain unexplored.
Study Objective This pilot randomised crossover trial aims to compare the physiological effects of vibrating mesh versus jet nebulisation of salbutamol during NIV in patients with chronic respiratory failure due to COPD.
Methods Study Design A randomised crossover trial with participants receiving both interventions with a 48-hour washout period between treatments.
Participants We will recruit 12 patients with COPD currently receiving NIV under the care of the Lane Fox Unit. All participants will provide written informed consent prior to study procedures.
Procedures
Following consent, we will record baseline data including:
NIV settings Anthropometric measurements Arterial blood gas analysis Clinical observations
Participants will be randomised to receive salbutamol via either VMN or JN during NIV. We will measure the following parameters at multiple time points within one hour after nebulisation:
Neural respiratory drive via parasternal electromyography Spirometry Respiratory impedance (mechanics of breathing)
Participants will self-report breathlessness using both a numerical scale and a validated scale.
After a minimum of 48-hour washout period, participants will return to repeat the protocol with the alternative nebuliser type.
- Being tested
- Vibrating mesh nebulisation, Jet nebuliser
- Keywords
- vibrating mesh nebuliser, jet nebuliser
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating mesh nebulisationDevice
Vibrating mesh nebulisation (VMN) uses a mesh membrane that oscillates at high frequency (typically 128kHz) to produce a stream of drug-carrying droplets of pre-determined size to be inhaled
Jet nebuliserDevice
Jet nebulisers use the flow of a gas (air or oxygen) to draw medication up through a capillary tube to generate small particles to be inhaled.
| Study group | Role | What they receive |
|---|---|---|
| 1st Vibrating mesh nebulisation and 2nd jet nebulisation | Experimental | Participants will receive a single dose of salbutamol whilst on NIV via vibrating mesh nebulisation on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via jet nebulisation while on NIV. Receives: Device: Vibrating mesh nebulisation; Device: Jet nebuliser |
| 1st Jet nebulisation and 2nd vibrating mesh nebulisation | Experimental | Participants will receive a single dose of salbutamol whilst on NIV via jet nebuliser on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via vibrating mesh nebuliser while on NIV. Receives: Device: Vibrating mesh nebulisation; Device: Jet nebuliser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural respiratory drive
Change in neural respiratory drive (NRD) 30 mins following vibrating mesh or jet nebulisation with a bronchodilator (2.5mg salbutamol) during NIV. This will be measured using surface second intercostal space parasternal muscle EMG. This reflects the load-capacity relationship of the respiratory system and will likely decrease with more effective bronchodilation and secretion clearance.
Measured: NRD assessed on both visits at baseline and 5, 15, 30 and 60 minutes after nebulisation
Secondary outcomes (10)
Respiratory System impedence
Change in respiratory system impedance 5 and 60 minutes after vibrating mesh or jet nebulisation therapy with 2.5mg salbutamol during NIV. Respiratory system impedance will be assessed using the forced oscillation technique (FOT).
Change in the difference in within-breath respiratory reactance at 5Hz (ΔXrs,5Hz) 5 and 60 minutes after vibrating mesh or jet nebulisation therapy with 2.5mg salbutamol during NIV, as measured by FOT
Measured: Both visits at baseline, 5 and 60 minutes post nebulisation therapy.
Symptom of Breathlessness (numerical rating scale)
Breathlessness numerical rating scale: This will allow patients to report their dyspnoea and how it may change with treatment. The scale ranges from 0 to 10, where 0 indicates no breathing difficulty and 10 represents maximal breathing difficulty.
Measured: At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
Symptom of Breathlessness (modified Borg Dyspnoea scale)
Patient perception of breathlessness will be assessed using the modified Borg dyspnoea scale (mBorg). The scale ranges from 0 to 10 (whole numbers plus 0.5), where - indicates no breathing difficulty and 10 represents maximal breathing difficulty.
Measured: At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
Transcutaneous CO2 Monitoring
Continuous transcutaneous carbon dioxide levels will be measured
Measured: At baseline and for 60 minutes following nebulisation
Spirometry - Forced expiratory volume in 1 second
Spirometry measurements of Forced expiratory volume in 1s second (FEV1)
Measured: At baseline and during 1 hour after administration of nebuliser on both visits
Spirometry - Forced vital capacity
Spirometry measurements of Forced vital capacity (FVC)
Measured: At baseline and during 1 hour after administration of nebuliser on both visits
Spirometry ratio - FEV1/FVC
Spirometry measurements used to calculate the ratio FEV1/FVC
Measured: At baseline and during 1 hour after administration of nebuliser on both visits
Cardiac rate
Assessment of cardiac rate at baseline and following administration of salbutamol via VMN and JN.
Measured: At baseline and for 60 minutes following nebulisation
Cardiac rhythm
Assessment of cardiac rate and rhythm at baseline and following administration of salbutamol via VMN and JN.
Measured: At baseline and for 60 minutes following nebulisation
Respiratory flow
Assessment of respiratory flow via pneumotrach at baseline and following administration of salbutamol via VMN and JN
Measured: At baseline and for 60 minutes following nebulisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start8 Apr 2025
- Primary completion12 Sep 2025
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot randomised crossover trial
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884228
- Sponsor's protocol ID
- 348845
- Acronym
- VMN-NIV
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.
PubMed 26976648Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet. 2000 Jun 3;355(9219):1931-5. doi: 10.1016/s0140-6736(00)02323-0.
PubMed 10859037Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. doi: 10.1136/thorax.55.10.817. No abstract available.
PubMed 10992531
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)
- ClinicalTrials.gov ID
- NCT06884228
- Acronym / sponsor ID
- VMN-NIV / 348845
- Keywords
- vibrating mesh nebuliser, jet nebuliser
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Mar 2025 (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.
Assessment of the effects of vibrating mesh nebulisation versus jet nebulisation on the electrical activity of the muscles involved in breathing (neural respiratory drive), breathing mechanics (respiratory impedance measured by forced oscillation technique), respiratory flow, heart rate and rhythm, spirometry and breathlessness symptoms in patients with chronic obstructive pulmonary disease who require non-invasive ventilation.
Detailed description
Background Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality in the United Kingdom. Acute exacerbations of COPD (AECOPD) frequently necessitate hospitalisation, with standard treatment comprising nebulised bronchodilators, antibiotics, and systemic corticosteroids. Approximately 20% of patients hospitalised with AECOPD require non-invasive ventilation (NIV) to manage decompensated hypercapnic respiratory failure, often necessitating concurrent administration of nebulised therapy.
Home NIV use is increasing among COPD patients to improve respiratory symptoms, quality of life, reduce hospitalisation frequency, and enhance survival. These patients may also require nebulised bronchodilator therapy during NIV, particularly when managing acute exacerbations not severe enough to warrant hospitalisation.
Currently, two nebulisation modalities are used as standard of care for patients on NIV:
Jet nebulisation (JN) - the conventional delivery method Vibrating mesh nebulisation (VMN) - a newer technology that utilises a mesh membrane oscillating at high frequency to produce drug-carrying droplets of predetermined size
VMN has been developed to optimise drug delivery in various patient populations, including those who are spontaneously breathing, receiving invasive mechanical ventilation, or on NIV. This technology is designed to enhance pulmonary drug deposition while minimising residual drug volume post-nebulisation.
Previous research has demonstrated that VMN achieves superior pulmonary drug deposition during NIV compared to JN in both healthy subjects and stable COPD patients. VMN has also been shown to produce greater improvements in forced expiratory volume in one second (FEV₁) among hospitalised patients. However, the comparative effects of these nebulisation methods on physiological parameters such as neural respiratory drive and respiratory system impedance during NIV in COPD patients with chronic respiratory failure remain unexplored.
Study Objective This pilot randomised crossover trial aims to compare the physiological effects of vibrating mesh versus jet nebulisation of salbutamol during NIV in patients with chronic respiratory failure due to COPD.
Methods Study Design A randomised crossover trial with participants receiving both interventions with a 48-hour washout period between treatments.
Participants We will recruit 12 patients with COPD currently receiving NIV under the care of the Lane Fox Unit. All participants will provide written informed consent prior to study procedures.
Procedures
Following consent, we will record baseline data including:
NIV settings Anthropometric measurements Arterial blood gas analysis Clinical observations
Participants will be randomised to receive salbutamol via either VMN or JN during NIV. We will measure the following parameters at multiple time points within one hour after nebulisation:
Neural respiratory drive via parasternal electromyography Spirometry Respiratory impedance (mechanics of breathing)
Participants will self-report breathlessness using both a numerical scale and a validated scale.
After a minimum of 48-hour washout period, participants will return to repeat the protocol with the alternative nebuliser type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| 1st Vibrating mesh nebulisation and 2nd jet nebulisation | Experimental | Device: Vibrating mesh nebulisation, Device: Jet nebuliserParticipants will receive a single dose of salbutamol whilst on NIV via vibrating mesh nebulisation on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via jet nebulisation while on NIV. |
| 1st Jet nebulisation and 2nd vibrating mesh nebulisation | Experimental | Device: Vibrating mesh nebulisation, Device: Jet nebuliserParticipants will receive a single dose of salbutamol whilst on NIV via jet nebuliser on their first visit. After a minimum 48-hour washout period, they will receive the same dose of salbutamol via vibrating mesh nebuliser while on NIV. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with COPD receiving home non-invasive ventilation for chronic respiratory failure under the Lane Fox Respiratory Service at Guy's and St Thomas' NHS Foundation Trust
- Tolerating home non-invasive ventilation for at least 4 hours/24 hours
- Aged 18-80 years old
- Able to communicate symptom burden to the research team
- Able to give informed consent for participation in the study
Key exclusion criteria (11 listed)
- Severe, non-respiratory organ dysfunction including, but not limited to:
- Acute pulmonary pathology requiring emergency treatment including, but not limited to:
- Severe cognitive impairment
- Psychosocial factors that would preclude completion of the study protocol
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 |
|---|---|---|
| Vibrating mesh nebulisationVibrating mesh nebulisation (VMN) uses a mesh membrane that oscillates at high frequency (typically 128kHz) to produce a stream of drug-carrying droplets of pre-determined size to be inhaled | Device | 1st Jet nebulisation and 2nd vibrating mesh nebulisation, 1st Vibrating mesh nebulisation and 2nd jet nebulisation |
| Jet nebuliserJet nebulisers use the flow of a gas (air or oxygen) to draw medication up through a capillary tube to generate small particles to be inhaled. | Device | 1st Jet nebulisation and 2nd vibrating mesh nebulisation, 1st Vibrating mesh nebulisation and 2nd jet nebulisation |
Primary outcome
Change in neural respiratory drive
Time frame: NRD assessed on both visits at baseline and 5, 15, 30 and 60 minutes after nebulisation
Change in neural respiratory drive (NRD) 30 mins following vibrating mesh or jet nebulisation with a bronchodilator (2.5mg salbutamol) during NIV. This will be measured using surface second intercostal space parasternal muscle EMG. This reflects the load-capacity relationship of the respiratory system and will likely decrease with more effective bronchodilation and secretion clearance.
10 secondary outcomes
Respiratory System impedence
Time frame: Both visits at baseline, 5 and 60 minutes post nebulisation therapy.
Symptom of Breathlessness (numerical rating scale)
Time frame: At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
Symptom of Breathlessness (modified Borg Dyspnoea scale)
Time frame: At baseline and at 5, 15, 30 and 60 minutes post nebulisation on both visits
Transcutaneous CO2 Monitoring
Time frame: At baseline and for 60 minutes following nebulisation
Spirometry - Forced expiratory volume in 1 second
Time frame: At baseline and during 1 hour after administration of nebuliser on both visits
Spirometry - Forced vital capacity
Time frame: At baseline and during 1 hour after administration of nebuliser on both visits
Spirometry ratio - FEV1/FVC
Time frame: At baseline and during 1 hour after administration of nebuliser on both visits
Cardiac rate
Time frame: At baseline and for 60 minutes following nebulisation
Cardiac rhythm
Time frame: At baseline and for 60 minutes following nebulisation
Respiratory flow
Time frame: At baseline and for 60 minutes following nebulisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 26976648Davidson AC, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church AC, Creagh-Brown B, Dodd JW, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson CM, Sovani M, Thomas L; BTS Standards of Care Committee Member, British Thoracic Society/Intensive Care Society Acute Hypercapnic Respiratory Failure Guideline Development Group, On behalf of the British Thoracic Society Standards of Care Committee. BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Thorax. 2016 Apr;71 Suppl 2:ii1-35. doi: 10.1136/thoraxjnl-2015-208209. No abstract available.
- Background: PubMed 10859037Plant PK, Owen JL, Elliott MW. Early use of non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease on general respiratory wards: a multicentre randomised controlled trial. Lancet. 2000 Jun 3;355(9219):1931-5. doi: 10.1016/s0140-6736(00)02323-0.
- Background: PubMed 10992531Brochard L. Non-invasive ventilation for acute exacerbations of COPD: a new standard of care. Thorax. 2000 Oct;55(10):817-8. doi: 10.1136/thorax.55.10.817. No abstract available.
- Individual participant dataSharing planned: No
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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.
Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP 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 Vibrating mesh nebulisation and Jet nebuliser in people with COPD (Chronic Obstructive Pulmonary Disease) and Non-invasive Ventilation, 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in neural respiratory drive (time frame: NRD assessed on both visits at baseline and 5, 15, 30 and 60 minutes after nebulisation). 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 NCT06884228, which also lists 3 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 10 Jul 2026.