Pulmonary Disease, Chronic ObstructivePhase 1NCT02619357
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
A Phase 1 study testing SenseWear Armband Gecko, SenseWear Armband MF and Actigraph GT9x wristband and waistband in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- SenseWear Armband Gecko, SenseWear Armband MF and Actigraph GT9x wristband and waistband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2015to 16 Mar 2016
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort 1 (COPD) >=45 years and <=70 years
- Cohort 2 (Asthma) >=18 years and <=70 years.
- Cohort 1; subjects with a confirmed diagnosis of COPD (Gold stage 2 and 3, COPD patients will be classified according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines) as defined by post-bronchodilator spirometry FEV1 >=40% and <80% predicted, and FEV1/FVC <0.7
- Cohort 2; subjects with documented, physician-diagnosed asthma.
- BMI within the range 19 to 32 kilogram(kg)/m^2 (inclusive)
- Male or female; A female of childbearing potential is eligible to enter and participate in the study if she has a negative pregnancy test at screening and day 1.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Alpha1-antitrypsin deficiency: Subjects with a diagnosis of alpha1-antitrypsin deficiency as the underlying cause of COPD, if known.
- Other respiratory disorders: Subjects with tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Pneumonia or other respiratory tract infection that has not resolved at least 14 days prior to screening. In addition, any subject that experiences pneumonia during any period between the screening visit and the study visit will be excluded.
- COPD or asthma exacerbation (in this case defined as a change in symptoms requiring increased doses of current medicines or the prescription of new medicines, e.g., corticosteroids or antibiotics) that has not resolved at least 28 days prior to screening. COPD or asthma exacerbation during any period between the screening visit and the study visit will be excluded.
- Presence of severe and/or poorly controlled asthma that in the opinion of the investigator renders participation in the study unsafe
Show all 14Show fewer
- Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing: orthopaedic, neurological, cardiovascular or other complaints that significantly impair normal biomechanical movement patterns and limit the ability to walk/cycle as judged by the investigator.
- Resting oxyhemoglobin saturation <94%.
- Use of supplemental oxygen therapy during the day or night.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol (males >21 units per week and females >14 units per week) or drug abuse within the last 2 years. One unit is equivalent to 8 gram (g) of alcohol: a half-pint (~240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Inability to abstain from smoking during the period in which the subject is admitted to the Clinical Unit.
- A history of allergy or hypersensitivity to metal, particularly stainless steel.
- Clinically significant abnormality on electrocardiogram (ECG) as determined by the investigator.
- Any vital sign indicator, e.g., hypertension or tachycardia at rest that at the discretion of the investigator would make participation in the study unsafe or unfeasible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Method Validation, Single-period, Open-label Evaluation Study to Explore the Sensitivity of a Novel Biosensor Device (SenseWear Armband Gecko) for Measuring Physical Activity in Subjects With COPD & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational studies. However, the accuracy and reproducibility of any given device may vary with device design and algorithm implementation. Therefore, validation of emerging technologies against known standards such as analysis of exhaled breath and currently available medical devices is critical. This is a single center, two-cohort, single period, open-label, methodology study. No investigational product will be used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2 ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2 activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will perform a variety of laboratory and field-based exercise tests and strength exercises using Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices in subjects with COPD or asthma while performing laboratory-based exercise testing.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband, Garmin Vivofit 2 wristband, SOMNOwatch plus EEG 6 sleep monitor
- Keywords
- Asthma, wearable physical activity monitor, step counts, Exercise, energy expenditure, COPD, indirect calorimetry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenseWear Armband GeckoDevice
Subjects will wear SenseWear Armband Gecko up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
SenseWear Armband MFDevice
Subjects will wear SenseWear Armband MF up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
Actigraph GT9x wristband and waistbandDevice
Subjects will wear Actigraph GT9x wristband and waistband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
Garmin Vivofit 2 wristbandDevice
Subjects will wear Garmin Vivofit 2 wristband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
SOMNOwatch plus EEG 6 sleep monitorDevice
In a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration.
Strength exercisesOther
Subjects will perform strength exercises using elastic bands of varying resistance
Field-based exercise testsOther
Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).
Laboratory-based exercise testsOther
Subjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 10 subjects diagnosed with COPD (GOLD stages 2 and 3). Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and Garmin Vivofit 2 wristband) up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests. Receives: Device: SenseWear Armband Gecko; Device: SenseWear Armband MF; Device: Actigraph GT9x wristband and waistband; Device: Garmin Vivofit 2 wristband; Device: SOMNOwatch plus EEG 6 sleep monitor; Other: Strength exercises; Other: Field-based exercise tests; Other: Laboratory-based exercise tests |
| Cohort 2 | Experimental | 10 subjects diagnosed with asthma. Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and Garmin Vivofit 2 wristband) up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests. Receives: Device: SenseWear Armband Gecko; Device: SenseWear Armband MF; Device: Actigraph GT9x wristband and waistband; Device: Garmin Vivofit 2 wristband; Device: SOMNOwatch plus EEG 6 sleep monitor; Other: Strength exercises; Other: Field-based exercise tests; Other: Laboratory-based exercise tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure [kilocalories per minute]
Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.
Measured: Up to Day 2
Energy expenditure [metabolic equivalents]
Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.
Measured: Up to Day 2
Step counts [total number of steps taken]
Step counts will be collected by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between devices and with manually counted steps, where available.
Measured: Up to Day 2
Secondary outcomes (5)
Number of subjects with adverse events (AE) or serious adverse events (SAE).
AEs and SAEs will be collected for each subject from the start of study until the follow-up contact
Measured: From the start of Study procedures until follow-up (6 days)
Number of subjects with abnormal vital signs related to interventions.
Oral temperature (degrees Celsius), systolic and diastolic blood pressure (mmHg), heart rate (beats per minute), respiratory rate (breaths per minute), and oxygen saturation (percent) will be collected at various times throughout the study.
Measured: Screening and Days 1 and 2
Forced Expiratory Volume in 1 second (FEV1)
Post-salbutamol spirometry will be obtained at screening, if necessary. Post- salbutamol FEV1 will be determined.
Measured: Screening
Ratio of FEV1 and Forced Vital Capacity (FVC)
Ratio of FEV1 and Forced Vital Capacity (FVC) will be determined at screening.
Measured: Screening
Borg dyspnea index score
Borg dyspnea scores will be obtained during and after exercise.
Measured: Days 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start21 Sep 2015
- Primary completion16 Mar 2016
- Study completion16 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619357
- Sponsor's protocol ID
- 202373
- Status last verified
- May 2017
- First submitted
- 27 Aug 2015
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Method Validation, Single-period, Open-label Evaluation Study to Explore the Sensitivity of a Novel Biosensor Device (SenseWear Armband Gecko) for Measuring Physical Activity in Subjects With COPD & Asthma
- ClinicalTrials.gov ID
- NCT02619357
- Acronym / sponsor ID
- 202373
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Asthma, wearable physical activity monitor, step counts, Exercise, energy expenditure, COPD, indirect calorimetry
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2015 (actual)
- Primary completion
- 16 Mar 2016 (actual)
- Study completion
- 16 Mar 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational studies. However, the accuracy and reproducibility of any given device may vary with device design and algorithm implementation. Therefore, validation of emerging technologies against known standards such as analysis of exhaled breath and currently available medical devices is critical. This is a single center, two-cohort, single period, open-label, methodology study. No investigational product will be used in this study. Eligible subjects will wear 2 generations of SenseWear Armband devices, 2 ActiGraph GT9x devices (one on the wrist and one on the waist) and a Garmin Vivofit 2 activity tracker wristband for up to 24 hours per day. Subjects who consent to participate in an optional sub-study will wear a SOMNOwatch Plus EEG-6 device while sleeping. Subjects will perform a variety of laboratory and field-based exercise tests and strength exercises using Latex-Free Therabands.The co-primary objectives of this study are firstly to compare the outputs of the test devices (SenseWear Armband Gecko and Actigraph GT9x) to those of the SenseWear Armband MF and secondly to assess the sensitivity and accuracy of the test devices in subjects with COPD or asthma while performing laboratory-based exercise testing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Device: SenseWear Armband Gecko, Device: SenseWear Armband MF, Device: Actigraph GT9x wristband and waistband, Device: Garmin Vivofit 2 wristband, Device: SOMNOwatch plus EEG 6 sleep monitor, Other: Strength exercises, Other: Field-based exercise tests, Other: Laboratory-based exercise tests10 subjects diagnosed with COPD (GOLD stages 2 and 3). Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and Garmin Vivofit 2 wristband) up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests. |
| Cohort 2 | Experimental | Device: SenseWear Armband Gecko, Device: SenseWear Armband MF, Device: Actigraph GT9x wristband and waistband, Device: Garmin Vivofit 2 wristband, Device: SOMNOwatch plus EEG 6 sleep monitor, Other: Strength exercises, Other: Field-based exercise tests, Other: Laboratory-based exercise tests10 subjects diagnosed with asthma. Subjects will wear multiple devices simultaneously (SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband and Garmin Vivofit 2 wristband) up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cohort 1 (COPD) >=45 years and <=70 years
- Cohort 2 (Asthma) >=18 years and <=70 years.
- Cohort 1; subjects with a confirmed diagnosis of COPD (Gold stage 2 and 3, COPD patients will be classified according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines) as defined by post-bronchodilator spirometry FEV1 >=40% and <80% predicted, and FEV1/FVC <0.7
- Cohort 2; subjects with documented, physician-diagnosed asthma.
- BMI within the range 19 to 32 kilogram(kg)/m^2 (inclusive)
Key exclusion criteria (14 listed)
- Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- Alpha1-antitrypsin deficiency: Subjects with a diagnosis of alpha1-antitrypsin deficiency as the underlying cause of COPD, if known.
- Other respiratory disorders: Subjects with tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
- Pneumonia or other respiratory tract infection that has not resolved at least 14 days prior to screening. In addition, any subject that experiences pneumonia during any period between the screening visit and the study visit will be excluded.
- COPD or asthma exacerbation (in this case defined as a change in symptoms requiring increased doses of current medicines or the prescription of new medicines, e.g., corticosteroids or antibiotics) that has not resolved at least 28 days prior to screening. COPD or asthma exacerbation during any period between the screening visit and the study visit will be excluded.
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 |
|---|---|---|
| SenseWear Armband GeckoSubjects will wear SenseWear Armband Gecko up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests | Device | Cohort 1, Cohort 2 |
| SenseWear Armband MFSubjects will wear SenseWear Armband MF up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests | Device | Cohort 1, Cohort 2 |
| Actigraph GT9x wristband and waistbandSubjects will wear Actigraph GT9x wristband and waistband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests | Device | Cohort 1, Cohort 2 |
| Garmin Vivofit 2 wristbandSubjects will wear Garmin Vivofit 2 wristband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests | Device | Cohort 1, Cohort 2 |
| SOMNOwatch plus EEG 6 sleep monitorIn a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration. | Device | Cohort 1, Cohort 2 |
| Strength exercisesSubjects will perform strength exercises using elastic bands of varying resistance | Other | Cohort 1, Cohort 2 |
| Field-based exercise testsSubjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB). | Other | Cohort 1, Cohort 2 |
| Laboratory-based exercise testsSubjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill | Other | Cohort 1, Cohort 2 |
Primary outcome
Energy expenditure [kilocalories per minute]
Time frame: Up to Day 2
Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.
Energy expenditure [metabolic equivalents]
Time frame: Up to Day 2
Energy expenditure will be assessed by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between test devices and with information derived from indirect calorimetry obtained by exhaled gas analysis, where available.
Step counts [total number of steps taken]
Time frame: Up to Day 2
Step counts will be collected by test devices at various levels of exertion during field-based and laboratory-based exercise tests. Graphical and/or statistical comparisons will be made between devices and with manually counted steps, where available.
5 secondary outcomes
Number of subjects with adverse events (AE) or serious adverse events (SAE).
Time frame: From the start of Study procedures until follow-up (6 days)
Number of subjects with abnormal vital signs related to interventions.
Time frame: Screening and Days 1 and 2
Forced Expiratory Volume in 1 second (FEV1)
Time frame: Screening
Ratio of FEV1 and Forced Vital Capacity (FVC)
Time frame: Screening
Borg dyspnea index score
Time frame: Days 1 and 2
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 15 May 2017.
- Results for study 202373 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Related trials for Pulmonary Disease, Chronic Obstructive
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SenseWear Armband Gecko, SenseWear Armband MF and Actigraph GT9x wristband and waistband in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 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 15 May 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Energy expenditure [kilocalories per minute] (time frame: Up to Day 2). The study lists 3 primary outcomes in all. 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 15 May 2017; AzTrials last refreshed its copy on 31 Oct 2026.