Severe Eosinophilic AsthmaSAMBANCT04680611
Severe Asthma, MepolizumaB and Affect: SAMBA Study
An observational study of Severe Eosinophilic Asthma and Psychological Distress, run by University Hospital Southampton NHS Foundation Trust at 6 sites in United Kingdom.
Trial summary
This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Eosinophilic Asthma, Psychological Distress, Anxiety
- What is being tested?
- no study intervention. Patients receive standard clinical care
- How many people
- 120 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 9 Sep 2021to 26 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe eosinophilic asthma on mepolizumab treatment (Phase 1) Patients with sereve eosinophilic asthma who are to start mepolizumab treatment and their partners ( Phase 2 and 3)
Who may be able to join
- Phase 1:
- Age 18 or over
- Having a diagnosis of severe eosinophilic asthma
- Currently on mepolizumab (Nucala®) treatment
- At least basic command of English
- Giving written informed consent
Show all 13Show fewer
- Phase 2 Patient eligibility Inclusion criteria
- Age 18 or over
- Having a diagnosis of severe eosinophilic asthma
- Scheduled to start mepolizumab (Nucala®) treatment
- At least basic command of English (for sub-study: conversational level of English that does not require a translator)
- Giving written informed consent
- Co-habiting with an intimate partner who is willing to participate in the study
Who cannot join
- Participated in Phase 1
- Currently on mepolizumab (Nucala®) treatment
- Major psychiatric disorder currently under treatment
- History of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months
- Any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease).
- Partners only: diagnosis of severe eosinophilic asthma
Show all 22Show fewer
- Death of spouse, main informal carer or first-degree family member within the last 3 months
- Current oral corticosteroid maintenance treatment
- Partner eligibility Inclusion criteria
- Age 18 or over
- At least basic command of English (for sub-study: conversational level of English that does not require a translator)
- Giving written informed consent
- Partners: Co-habiting with an intimate partner who has severe eosinophilic asthma and is willing to participate in the study
- Participated in Phase 1
- Major psychiatric disorder currently under treatment
- Participant self-reported history of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months.
- Participant self-reported any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease).
- Diagnosis of severe eosinophilic asthma
- Death of spouse, main informal carer or first-degree family member within the last 3 months
- Current oral corticosteroid maintenance treatment
- Phase 3:
- Phase 3 is a qualitative study on a sample of couples from Phase 2 therefore the same exclusion criteria will apply as in Phase 2.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Department of Respiratory Medicine, Aberdeen Royal Infirmary
Aberdeen, Grampian, AB25 2ZN
Glasgow Gartnavel General Hospital
Glasgow, G12 0YN
Hull University Teaching Hospitals NHS Trust
Hull, Yorkshire, HU16 5JQ
Portsmouth Hospitals NHS Trust
Portsmouth
Judit Varkonyi-Sepp
Southampton, Hampshire, SO166YD
Pinderfields Hospital
Wakefield, Yorkshire, WF1 4DG
About this study
Official title: The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners
This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).
Read the detailed description
This longitudinal observational study will investigate the relationship between patients' asthma control and emotional states and quality of life in patients and their partners where patients have severe eosinophilic asthma. The study will consist of three phases.
Phase 1 In order to extend our pilot study findings and help inform the second stage, investigators will gather Geneva Emotional Wheel (GEW) data from 30 patients currently treated and benefitting from mepolizumab (Nucala®). This data will be compared to the GEW data investigators have already gathered from patients with severe asthma not receiving treatment with mepolizumab (Nucala®). This will provide timely data to support a publication on the GEW findings in severe asthma and allow the description of the impact of mepolizumab (Nucala®). In addition, it will help provide power calculations for a prospective study. Parallel assessment of quality of life (SGRQ and SAQ) and anxiety and depression (HADS) will be made to evaluate the relationship between GEW, SGRQ, SAQ and HADS scores.
Phase 2 In the second stage, investigators will conduct a prospective study of 45 patients newly prescribed mepolizumab (Nucala®) and their partners measuring participants' emotional composition before and 6 and 12 months after starting treatment. The choice of 60 has been based on likely power requirements but was adjusted to 45 based in Phase 1 results. Investigators will also compare the outcomes from the GEW with other standard outcome measures (HADS, ACQ, SGRQ, SAQ, BIPQ), to establish relationship between changes in these measures and changes in GEW scores, to evaluate the utility of the GEW. This will help determine if the GEW reflects changes in asthma control or whether it is reflecting improvements that the current established instruments do not recognise and allow us to quantify the magnitude of that effect. As these patients will receive mepolizumab as part of their clinical care for a year, whilst assessment of clinical efficacy is being established, investigators will gather data on oral steroid dependent exacerbations (severe exacerbations) during this year and relate to their historic exacerbation history in the year before. Evaluation will be made as to whether the 6-month improvement in GEW scores predicts impact of mepolizumab on exacerbation reduction over the first year of administration. In addition, improvements in the GEW will be explored in relationship to systemic inflammatory impact, with measures of blood eosinophils and serum inflammatory biomarkers (Olink inflammatory panel) at baseline, 6 months and 1 year.
Phase 3 Finally, in addition, investigators will conduct qualitative research in the form of semi-structured interviews with a sub-set of couples (20 couples or less if no new information emerges from the interviews) to gain a more detailed insight and identify common key aspects in their subjective experiences, quality of life and emotional processes before starting treatment and after being on treatment with mepolizumab for 6 months.
- Conditions
- Severe Eosinophilic Asthma, Psychological Distress, Anxiety, Depression, Psychological Stress, Psychological Adjustment
- Being tested
- no study intervention. Patients receive standard clinical care
- Medical subject headings
- Pulmonary Eosinophilia, Anxiety Disorders, Depression, Stress, Psychological, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no study intervention. Patients receive standard clinical careOther
Also called no intervention. observational study
no intervention. observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe eosinophilic asthma Phase 1 | Patients with severe eosinophilic asthma on Nucala(R) treatment Receives: Other: no study intervention. Patients receive standard clinical care | |
| Patients with severe eosinophilic asthma Phase 2 | Patients with severe eosinophilic asthma to start Nucala(R) treatment Receives: Other: no study intervention. Patients receive standard clinical care | |
| Partners of patients with severe eosinophilic asthma Phase 2 | Partners of patients with severe eosinophilic asthma to start Nucala(R) treatment | |
| Phase 3: Patients with severe eosinophilic asthma from Phase 2 | A sub-group of patients who participate in Phase 2 Receives: Other: no study intervention. Patients receive standard clinical care | |
| Phase 3: Partners of patients in Phase 3 | Partners of the sub-group of patients who participate in Phase 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Composition (Using the Geneva Emotions Wheel)
A 20-item self-report questionnaire identifying 20 discrete emotions with positive or negative valence. Emotions with positive valence are Interest, Amusement, Pride, Joy, Pleasure, Acceptance, Love, Admiration, relief, Compassion. Emotions with negative valence are: Sadness, Guilt, Regret, Shame, Disappointment, Hopelessness, Fear, Contempt, Hate and Anger. The intensity of each emotion can be marked on a 6-point Likert-type scale with circles indicating intensities. For the statistical analysis, these were computed between 0 ( smallest circles ) to 5 ( largest circles) . Lower scores indicate lower intensity of emotions, higher scores indicate higher intensity of emotions. Changes in the individual emotion scores were the outcomes of interest and are given below.
Measured: Change to one year after start of treatment
Secondary outcomes (5)
Change in Affective State (Using the Hospital Anxiety and Depression Scale)
Clinical diagnostic self-report questionnaire to assess psychological distress. Consists of anxiety and depression sub-scales. It consists of seven questions for anxiety and seven questions for depression that are in mixed order in the questionnaire. Each question has four possible answers scored from 0-3. There are separate sub-scale scores for anxiety and depression each with cut-off scores 0-7: normal, 8-10: borderline abnormal and 11-21: abnormal. Lower scores mean better outcomes. The HADS is a self-report tool and takes 2-5minutes to complete.
Measured: Change from baseline to 1 year after start of treatment
Change in Self-reported Asthma Symptom Control (Using the Asthma Control Questionnaire)
6-item clinical questionnaire to establish self-assessed asthma control (questions 1-6) and lung function measured by healthcare professional (item 7). 6 of the questions are patients self-report about their asthma during the previous week regarding symptoms and bronchodilator use. Responses are given on a 7-point scale (0=no impairment, 6= maximum impairment). The ACQ score is the mean of all the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). In general, patients with a score below 1.0 have adequately controlled asthma and above 1.0 their asthma is not controlled. Patients with a score between 0.75 and 1.25 have borderline of adequate control. The smallest clinically important change is 0.5.
Measured: Change from baseline to 1 year after start of treatment
Change in Functioning and Quality of Life (Using the St Georges Respiratory Questionnaire)
Clinical questionnaire to assess disease impact on quality of life. The questionnaire has two parts. Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over the preceding period (range 1 month to 1 year). Part 2 (Questions 9 to 16) is related to the patients' current state. The answers to the questions can be grouped in to 3 subscales. The Symptom score is reflective of physical wellbeing over the last year .The Activity score covers functioning related to patients' current daily physical activity. The Impacts score relates to the psychosocial functioning. Subscale total scores can be between 0 (no impairment ) to 100 ( maximum impairment). Scoring is weighted and higher scores indicate worse outcomes. Clinically, the total score is used as a meaningful outcome measure.
Measured: Change from baseline to 1 year after start of treatment
Change in Asthma-related Quality of Life (Using the Severe Asthma Questionnaire)
Severe Asthma Questionnaire (SAQ) assesses the impact of severe asthma and the effects of treatment on patient's self-reported health-related quality of life. The questionnaire produces two scores: a total domain score and a global quality of life score.1. The total domain score is the aggregation of 16 different Quality of Life (QoL) domains ( individual scores are between 1 and 7) where higher scores indicate higher adverse impact on the responder's life. The total score for this domain is obtained by the sum of scores divided by the number of questions answered and can be between 1 and 7. 2. SAQ-global score where participants scire their quality of life on a 100-point scale. Higher scores mean better quality of life. The scale takes between 3 to 6 minutes to complete, but completion time reduces on subsequent occasions.
Measured: Change from baseline to 1 year after start of treatment
Change in Illness Perception (Using the Brief Illness Perception Questionnaire)
Questionnaire assessing the beliefs individuals have about the cause, controllability and impact on them of the illness. Comprises 9 questions. 8 questions use a Likert scale response. Question 9 can be answered by free text about the perceived cause of illness. Total scores can be between 0 and 80 with higher scores indicating worse outcomes.
Measured: Change from baseline to 1 year after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start9 Sep 2021
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Severe Eosinophilic AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Derby, Glasgow Gartnavel General Hospital, Hull University Teaching Hospitals NHS Trust, Aberdeen Royal Infirmary, Mid Yorkshire Teaching NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680611
- Sponsor's protocol ID
- RHM MED1740
- Acronym
- SAMBA
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2020
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised and aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners
- ClinicalTrials.gov ID
- NCT04680611
- Acronym / sponsor ID
- SAMBA / RHM MED1740
- Conditions
- Severe Eosinophilic Asthma, Psychological Distress, Anxiety, Depression, Psychological Stress, Psychological Adjustment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Portsmouth Hospitals NHS Trust, University of Derby, Glasgow Gartnavel General Hospital, Hull University Teaching Hospitals NHS Trust, Aberdeen Royal Infirmary, Mid Yorkshire Teaching NHS Trust
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).
Detailed description
This longitudinal observational study will investigate the relationship between patients' asthma control and emotional states and quality of life in patients and their partners where patients have severe eosinophilic asthma. The study will consist of three phases.
Phase 1 In order to extend our pilot study findings and help inform the second stage, investigators will gather Geneva Emotional Wheel (GEW) data from 30 patients currently treated and benefitting from mepolizumab (Nucala®). This data will be compared to the GEW data investigators have already gathered from patients with severe asthma not receiving treatment with mepolizumab (Nucala®). This will provide timely data to support a publication on the GEW findings in severe asthma and allow the description of the impact of mepolizumab (Nucala®). In addition, it will help provide power calculations for a prospective study. Parallel assessment of quality of life (SGRQ and SAQ) and anxiety and depression (HADS) will be made to evaluate the relationship between GEW, SGRQ, SAQ and HADS scores.
Phase 2 In the second stage, investigators will conduct a prospective study of 45 patients newly prescribed mepolizumab (Nucala®) and their partners measuring participants' emotional composition before and 6 and 12 months after starting treatment. The choice of 60 has been based on likely power requirements but was adjusted to 45 based in Phase 1 results. Investigators will also compare the outcomes from the GEW with other standard outcome measures (HADS, ACQ, SGRQ, SAQ, BIPQ), to establish relationship between changes in these measures and changes in GEW scores, to evaluate the utility of the GEW. This will help determine if the GEW reflects changes in asthma control or whether it is reflecting improvements that the current established instruments do not recognise and allow us to quantify the magnitude of that effect. As these patients will receive mepolizumab as part of their clinical care for a year, whilst assessment of clinical efficacy is being established, investigators will gather data on oral steroid dependent exacerbations (severe exacerbations) during this year and relate to their historic exacerbation history in the year before. Evaluation will be made as to whether the 6-month improvement in GEW scores predicts impact of mepolizumab on exacerbation reduction over the first year of administration. In addition, improvements in the GEW will be explored in relationship to systemic inflammatory impact, with measures of blood eosinophils and serum inflammatory biomarkers (Olink inflammatory panel) at baseline, 6 months and 1 year.
Phase 3 Finally, in addition, investigators will conduct qualitative research in the form of semi-structured interviews with a sub-set of couples (20 couples or less if no new information emerges from the interviews) to gain a more detailed insight and identify common key aspects in their subjective experiences, quality of life and emotional processes before starting treatment and after being on treatment with mepolizumab for 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with severe eosinophilic asthma Phase 1 | – | Other: no study intervention. Patients receive standard clinical carePatients with severe eosinophilic asthma on Nucala(R) treatment |
| Patients with severe eosinophilic asthma Phase 2 | – | Other: no study intervention. Patients receive standard clinical carePatients with severe eosinophilic asthma to start Nucala(R) treatment |
| Partners of patients with severe eosinophilic asthma Phase 2 | – | –Partners of patients with severe eosinophilic asthma to start Nucala(R) treatment |
| Phase 3: Patients with severe eosinophilic asthma from Phase 2 | – | Other: no study intervention. Patients receive standard clinical careA sub-group of patients who participate in Phase 2 |
| Phase 3: Partners of patients in Phase 3 | – | –Partners of the sub-group of patients who participate in Phase 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe eosinophilic asthma on mepolizumab treatment (Phase 1) Patients with sereve eosinophilic asthma who are to start mepolizumab treatment and their partners ( Phase 2 and 3)
Key inclusion criteria (13 listed)
- Age 18 or over
- Having a diagnosis of severe eosinophilic asthma
- Currently on mepolizumab (Nucala®) treatment
- At least basic command of English
- Giving written informed consent
Key exclusion criteria (22 listed)
- Participated in Phase 1
- Currently on mepolizumab (Nucala®) treatment
- Major psychiatric disorder currently under treatment
- History of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months
- Any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease).
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 |
|---|---|---|
| no study intervention. Patients receive standard clinical careAlso: no intervention. observational studyno intervention. observational study | Other | Patients with severe eosinophilic asthma Phase 1, Patients with severe eosinophilic asthma Phase 2, Phase 3: Patients with severe eosinophilic asthma from Phase 2 |
Primary outcome
Change in Emotional Composition (Using the Geneva Emotions Wheel)
Time frame: Change to one year after start of treatment
A 20-item self-report questionnaire identifying 20 discrete emotions with positive or negative valence. Emotions with positive valence are Interest, Amusement, Pride, Joy, Pleasure, Acceptance, Love, Admiration, relief, Compassion. Emotions with negative valence are: Sadness, Guilt, Regret, Shame, Disappointment, Hopelessness, Fear, Contempt, Hate and Anger. The intensity of each emotion can be marked on a 6-point Likert-type scale with circles indicating intensities. For the statistical analysis, these were computed between 0 ( smallest circles ) to 5 ( largest circles) . Lower scores indicate lower intensity of emotions, higher scores indicate higher intensity of emotions. Changes in the individual emotion scores were the outcomes of interest and are given below.
5 secondary outcomes
Change in Affective State (Using the Hospital Anxiety and Depression Scale)
Time frame: Change from baseline to 1 year after start of treatment
Change in Self-reported Asthma Symptom Control (Using the Asthma Control Questionnaire)
Time frame: Change from baseline to 1 year after start of treatment
Change in Functioning and Quality of Life (Using the St Georges Respiratory Questionnaire)
Time frame: Change from baseline to 1 year after start of treatment
Change in Asthma-related Quality of Life (Using the Severe Asthma Questionnaire)
Time frame: Change from baseline to 1 year after start of treatment
Change in Illness Perception (Using the Brief Illness Perception Questionnaire)
Time frame: Change from baseline to 1 year after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only anonymised and aggregate data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Eosinophilic Asthma and Psychological Distress, run by University Hospital Southampton NHS Foundation Trust at 6 sites 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 13 inclusion and 22 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 13 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 6 sites 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?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Emotional Composition (Using the Geneva Emotions Wheel) (time frame: Change to one year after start of treatment). 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 13 Jul 2026.