Breathing Pattern DisorderPHABNCT07543588
The Physiotherapy Assessment of Breathing Pattern Disorder
An observational study of Breathing Pattern Disorder and Breathlessness, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to evaluate a clinical tool called the Breathing Pattern Assessment Tool (BPAT), which is used by physiotherapists to assess breathing pattern disorder (BPD). BPD is a condition where breathing is inefficient or out of sync with the body's needs, leading to symptoms such as breathlessness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breathing Pattern Disorder, Breathlessness
- What is being tested?
- Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Dec 2024to 1 May 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with BPD (n=100) A convenience sample of patients referred to physiotherapy outpatient services of Royal Brompton Hospitals for BPD or unexplained breathlessness, over a 22-month recruitment period will be recruited. Healthy control (n=25) A convenience sample of healthy controls will be recruited from relative/significant other accompanying the study participant and/or hospital staff. Asthma control patients (n=25) Patients will be recruited from the Systematic Assessment of Asthma Clinic and data used from their completed usual care assessment.
Who may be able to join
- Adults aged above 18 years
- Outpatient referrals for 'unexplained breathlessness' or possible breathing pattern disorder
- Primary BPD (no other significant respiratory or cardiology diagnosis)
- Secondary BPD (patients with a diagnosis of asthma)
- Able to complete up to four sessions of outpatient physiotherapy intervention Exclusion Criteria
- Patients with a respiratory diagnosis including COPD, ILD, Bronchiectasis and Cystic Fibrosis or structural heart disease
Show all 10Show fewer
- Pregnancy
- Unable to give informed consent
- Anyone currently participating in pulmonary/cardiac rehabilitation
- Anyone receiving specialist ENT speech and language therapy for Upper airway symptoms
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton Hospital
London, London, SW3 6NP
Lizzie JF Grillo, MSc, +447843203979, l.grillo@imperial.ac.uk
Lizzie JF Grillo, MSc
About this study
Official title: An Evaluation of Physiotherapy Assessment; A Mixed Methods Study to Evaluate the Physiotherapy Assessment of Breathing Pattern Disorder
This study aims to evaluate a clinical tool called the Breathing Pattern Assessment Tool (BPAT), which is used by physiotherapists to assess breathing pattern disorder (BPD). BPD is a condition where breathing is inefficient or out of sync with the body's needs, leading to symptoms such as breathlessness.
The study will investigate whether the BPAT is a reliable and accurate way to identify and assess BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. It will also compare BPAT scores with other commonly used questionnaires that measure breathlessness and breathing symptoms.
Read more
Participants will include patients with BPD, patients with asthma, and healthy individuals. Patients with BPD will attend physiotherapy sessions as part of their usual care, during which their breathing will be assessed using the BPAT at different time points, including before and after treatment. Healthy participants will attend a single assessment visit, and asthma participants' data will be collected from routine clinical care.
The study will also explore whether BPAT scores change following treatment and whether these changes reflect improvements reported by patients and clinicians.
In addition, a small number of patients and physiotherapists will be invited to take part in interviews to share their experiences of the assessment process and treatment. This will help understand whether the BPAT is acceptable and useful in clinical practice.
Overall, this study aims to improve how breathing pattern disorder is assessed and monitored, which may help guide better treatment for patients in the future.
Read the detailed description
This study will evaluate the measurement properties and clinical usefulness of the Breathing Pattern Assessment Tool (BPAT), a physiotherapist-completed assessment used to identify breathing pattern disorder (BPD). BPD is a condition in which breathing is inefficient or inappropriate for the body's needs and is associated with symptoms such as breathlessness.
The study aims to determine whether the BPAT is a reliable and valid method for identifying and assessing BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. BPAT scores will be compared with established questionnaires that measure breathing symptoms and breathlessness. The study will also assess whether changes in BPAT scores reflect changes reported by patients and clinicians.
Participants will include patients with BPD (n=100), patients with asthma (n=25), and healthy controls (n=25). Patients with BPD will be recruited from physiotherapy outpatient services and will receive physiotherapy as part of usual care. Healthy controls will attend a single assessment visit, and asthma control data will be obtained from routine clinical assessments.
At the initial assessment, two physiotherapists will independently complete BPAT scores for each participant. Patients with BPD will attend a follow-up assessment within approximately 4 weeks, where a repeat BPAT assessment will be completed. Those diagnosed with BPD will then undergo a course of physiotherapy treatment as part of usual care, typically consisting of four sessions. BPAT and other outcome measures will be repeated at the end of treatment (up to 6 months). Patients and clinicians will also provide ratings of change in symptoms following treatment.
The study will evaluate the reliability of the BPAT between clinicians and across time, its validity through comparison with other commonly used outcome measures, and its responsiveness to change following treatment.
In addition, a subgroup of patients and physiotherapists will take part in qualitative interviews to explore their experiences of the BPAT and its use in clinical practice. These interviews will help assess the acceptability and practicality of the tool.
This mixed-methods study aims to improve the assessment and monitoring of breathing pattern disorder and to support more consistent and effective clinical care.
- Conditions
- Breathing Pattern Disorder, Breathlessness
- Being tested
- Assessment of Breathing Pattern- Breathing Pattern Assessment Tool
- Keywords
- Breathlessness, Breathing Pattern Disorder, Physiotherapy, Assessment
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Breathing Pattern- Breathing Pattern Assessment ToolDiagnostic test
Patients who have Breathing Pattern Disorder will be assessed with the Breathing Pattern Assessment Tool and then will undergo Physiotherapy intervention. This includes up to 4 sessions of physiotherapy treatments which include biomechanical, biochemical and psychopathological interventions for breathing pattern
| Study group | Role | What they receive |
|---|---|---|
| Breathing Pattern Disorder | Patients referred to physiotherapy with a Breathing Pattern Disorder Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool | |
| Healthy Control | Patients with no respiratory symptoms or disorders Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool | |
| Asthma | Patients diagnosed with asthma but no concerns for breathing pattern disorder Receives: Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathing Pattern Assessment Tool BPAT
The Breathing Pattern Assessment Tool (BPAT) is a clinician-completed assessment of breathing pattern. Assessment components include (i) evaluation of chest/abdominal wall movement, noise of (ii) inspiratory and (iii) expiratory flow, (iv) channel of inspiration and expiration, (v) signs of air hunger (yawning, sighing and deeper breaths), (vi) RR and (vii) rhythm. Each component is scored from 0 (normal) to 2 (severely abnormal), with a total score ranging from 0 to 14. Higher scores indicate greater deviation from normal breathing patterns. Changes in score over time reflect changes in breathing pattern.
Measured: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Secondary outcomes (7)
Nijmegen Questionnaire
The Nijmegen Questionnaire is a 16-item patient-reported outcome measure assessing symptoms associated with breathing pattern disorder and hyperventilation. Each item is scored from 0 ("never") to 4 ("very often"), with a total score ranging from 0 to 64. Higher scores indicate greater symptom severity. Scores of 19 or above are commonly considered indicative of clinically significant symptoms. Changes in score over time reflect changes in symptom severity.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Dyspnoea 12 (D-12) Questionnaire
The Dyspnoea-12 Questionnaire is a 12-item patient-reported outcome measure assessing the severity of breathlessness, including both physical and affective components. Each item is scored from 0 ("none") to 3 ("severe"), with a total score ranging from 0 to 36. Higher scores indicate worse breathlessness (greater dyspnoea severity). Changes in score over time reflect changes in symptom severity.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life comprising a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels from 1 ("no problems") to 5 ("extreme problems"), which can be converted into a single index score. The descriptive system responses are converted into a single index score using established value sets, typically ranging from less than 0 (worse than death) to 1 (full health). The EQ VAS records self-rated health on a scale from 0 ("worst imaginable health") to 100 ("best imaginable health"). Higher scores indicate better health-related quality of life, while lower scores indicate poorer health status.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Breath Hold
Breath-Hold Time (seconds) is a functional measure of respiratory control and tolerance to carbon dioxide. It is assessed as the duration, in seconds, that a participant can comfortably hold their breath following a normal exhalation. Typical values in healthy adults are approximately 20 to 40 seconds. Higher values indicate better respiratory control and greater tolerance to carbon dioxide, while lower values indicate poorer tolerance and potential breathing pattern disorder (hyperventilation). Changes in breath-hold time over time reflect changes in respiratory function. There is no fixed upper limit; values are recorded in seconds.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
End Tidal C02
End-Tidal Carbon Dioxide (EtCO₂, mmHg) is an objective physiological measure of the partial pressure of carbon dioxide at the end of expiration, assessed using capnography via a nasal cannula. EtCO₂ is used as an indicator of ventilatory status. Lower values indicate relative hypocapnia and potential hyperventilation, while higher values within the normal physiological range indicate improved ventilatory regulation. Changes in EtCO₂ over time reflect changes in respiratory function. Normal values are typically approximately 35-45 mmHg or 4.7 to 6.0 kPa.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Breathing Vigilance Questionnaire
The Breathing Vigilance Questionnaire (Breathe-VQ) is a 6-item patient-reported measure assessing the degree of conscious monitoring and attentional focus on breathing. Each item is rated on a Likert scale, with total scores ranging from 6 to 30. Higher scores indicate greater breathing vigilance or hyper-awareness of breathing, which is associated with dysfunctional breathing patterns. Lower scores indicate less conscious monitoring of breathing. Changes in score over time reflect changes in breathing-related vigilance.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Self evaluation of breathing questionnaire
The Self-Evaluation of Breathing Questionnaire (SEBQ) is a patient-reported outcome measure assessing symptoms associated with dysfunctional breathing. It consists of 25 items, each scored on a Likert scale, with a total score ranging from 0 to 75. Higher scores indicate worse breathing pattern disorder/dysfunctional breathing. A total score greater than 11 has been suggested as indicative of possible dysfunctional breathing. Changes in score over time reflect changes in symptom severity.
Measured: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start10 Dec 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing Pattern DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lizzie Grillo, Royal Brompton & Harefield NHS Foundation Trust
- Investigators
- Lizzie JF Grillo, BSc MSc, Principal investigator, Royal Brompton and Harefield Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543588
- Sponsor's protocol ID
- 315897
- Acronym
- PHAB
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in publications, including baseline characteristics, outcome measures, and relevant covariates. All direct identifiers will be removed prior to sharing. Data will be made available for the IPD that underlie results in a publication. This will be available within the publication and anonymous data available on online repository
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Physiotherapy Assessment; A Mixed Methods Study to Evaluate the Physiotherapy Assessment of Breathing Pattern Disorder
- ClinicalTrials.gov ID
- NCT07543588
- Acronym / sponsor ID
- PHAB / 315897
- Conditions
- Breathing Pattern Disorder, Breathlessness
- Keywords
- Breathlessness, Breathing Pattern Disorder, Physiotherapy, Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
This study aims to evaluate a clinical tool called the Breathing Pattern Assessment Tool (BPAT), which is used by physiotherapists to assess breathing pattern disorder (BPD). BPD is a condition where breathing is inefficient or out of sync with the body's needs, leading to symptoms such as breathlessness.
The study will investigate whether the BPAT is a reliable and accurate way to identify and assess BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. It will also compare BPAT scores with other commonly used questionnaires that measure breathlessness and breathing symptoms.
Participants will include patients with BPD, patients with asthma, and healthy individuals. Patients with BPD will attend physiotherapy sessions as part of their usual care, during which their breathing will be assessed using the BPAT at different time points, including before and after treatment. Healthy participants will attend a single assessment visit, and asthma participants' data will be collected from routine clinical care.
The study will also explore whether BPAT scores change following treatment and whether these changes reflect improvements reported by patients and clinicians.
In addition, a small number of patients and physiotherapists will be invited to take part in interviews to share their experiences of the assessment process and treatment. This will help understand whether the BPAT is acceptable and useful in clinical practice.
Overall, this study aims to improve how breathing pattern disorder is assessed and monitored, which may help guide better treatment for patients in the future.
Detailed description
This study will evaluate the measurement properties and clinical usefulness of the Breathing Pattern Assessment Tool (BPAT), a physiotherapist-completed assessment used to identify breathing pattern disorder (BPD). BPD is a condition in which breathing is inefficient or inappropriate for the body's needs and is associated with symptoms such as breathlessness.
The study aims to determine whether the BPAT is a reliable and valid method for identifying and assessing BPD, and whether it can be used to monitor changes over time, particularly following physiotherapy treatment. BPAT scores will be compared with established questionnaires that measure breathing symptoms and breathlessness. The study will also assess whether changes in BPAT scores reflect changes reported by patients and clinicians.
Participants will include patients with BPD (n=100), patients with asthma (n=25), and healthy controls (n=25). Patients with BPD will be recruited from physiotherapy outpatient services and will receive physiotherapy as part of usual care. Healthy controls will attend a single assessment visit, and asthma control data will be obtained from routine clinical assessments.
At the initial assessment, two physiotherapists will independently complete BPAT scores for each participant. Patients with BPD will attend a follow-up assessment within approximately 4 weeks, where a repeat BPAT assessment will be completed. Those diagnosed with BPD will then undergo a course of physiotherapy treatment as part of usual care, typically consisting of four sessions. BPAT and other outcome measures will be repeated at the end of treatment (up to 6 months). Patients and clinicians will also provide ratings of change in symptoms following treatment.
The study will evaluate the reliability of the BPAT between clinicians and across time, its validity through comparison with other commonly used outcome measures, and its responsiveness to change following treatment.
In addition, a subgroup of patients and physiotherapists will take part in qualitative interviews to explore their experiences of the BPAT and its use in clinical practice. These interviews will help assess the acceptability and practicality of the tool.
This mixed-methods study aims to improve the assessment and monitoring of breathing pattern disorder and to support more consistent and effective clinical care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breathing Pattern Disorder | – | Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment ToolPatients referred to physiotherapy with a Breathing Pattern Disorder |
| Healthy Control | – | Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment ToolPatients with no respiratory symptoms or disorders |
| Asthma | – | Diagnostic Test: Assessment of Breathing Pattern- Breathing Pattern Assessment ToolPatients diagnosed with asthma but no concerns for breathing pattern disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with BPD (n=100) A convenience sample of patients referred to physiotherapy outpatient services of Royal Brompton Hospitals for BPD or unexplained breathlessness, over a 22-month recruitment period will be recruited. Healthy control (n=25) A convenience sample of healthy controls will be recruited from relative/significant other accompanying the study participant and/or hospital staff. Asthma control patients (n=25) Patients will be recruited from the Systematic Assessment of Asthma Clinic and data used from their completed usual care assessment.
Key inclusion criteria (10 listed)
- Adults aged above 18 years
- Outpatient referrals for 'unexplained breathlessness' or possible breathing pattern disorder
- Primary BPD (no other significant respiratory or cardiology diagnosis)
- Secondary BPD (patients with a diagnosis of asthma)
- Able to complete up to four sessions of outpatient physiotherapy intervention Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Assessment of Breathing Pattern- Breathing Pattern Assessment ToolPatients who have Breathing Pattern Disorder will be assessed with the Breathing Pattern Assessment Tool and then will undergo Physiotherapy intervention. This includes up to 4 sessions of physiotherapy treatments which include biomechanical, biochemical and psychopathological interventions for breathing pattern | Diagnostic test | Asthma, Breathing Pattern Disorder, Healthy Control |
Primary outcome
Breathing Pattern Assessment Tool BPAT
Time frame: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
The Breathing Pattern Assessment Tool (BPAT) is a clinician-completed assessment of breathing pattern. Assessment components include (i) evaluation of chest/abdominal wall movement, noise of (ii) inspiratory and (iii) expiratory flow, (iv) channel of inspiration and expiration, (v) signs of air hunger (yawning, sighing and deeper breaths), (vi) RR and (vii) rhythm. Each component is scored from 0 (normal) to 2 (severely abnormal), with a total score ranging from 0 to 14. Higher scores indicate greater deviation from normal breathing patterns. Changes in score over time reflect changes in breathing pattern.
7 secondary outcomes
Nijmegen Questionnaire
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Dyspnoea 12 (D-12) Questionnaire
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Breath Hold
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
End Tidal C02
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Breathing Vigilance Questionnaire
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
Self evaluation of breathing questionnaire
Time frame: Baseline for all participants; and through study completion (up to 6 months) for participants with Breathing Pattern Disorder
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 5 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in publications, including baseline characteristics, outcome measures, and relevant covariates. All direct identifiers will be removed prior to sharing. Data will be made available for the IPD that underlie results in a publication. This will be available within the publication and anonymous data available on online repository
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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.
Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc contact
Lizzie JF Grillo, BSc MSc principal investigator
Royal Brompton and Harefield Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breathing Pattern Disorder and Breathlessness, run by Royal Brompton & Harefield 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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 5 May 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?
Contact Lizzie Grillo JF Clinical Specialist Physiotherapist, BSc MSc (07843203979, lizzie.grillo1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathing Pattern Assessment Tool BPAT (time frame: Baseline for all participants; 4 weeks and through study completion (up to 6 months) for participants with Breathing Pattern Disorder). 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 5 May 2026.