AsthmaINCA-SUNNCT02307669
Inhaler Adherence in Severe Unstable Asthma
A study testing INCA feedback in people with Asthma, run by Beaumont Hospital at 1 site in Ireland.
Trial summary
The investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, compared to current best practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- INCA feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteIreland
- Study dates
- Dec 2015to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be willing to give voluntary informed consent
- Must have a clinical diagnosis of asthma supported by objective measures, one of the following by FEV1/FVC <70% and FEV1 <80% or - a 12% change in FEV1 following administration of a beta-agonist or spontaneously over 1 year period, a positive bronchial provocation test, or a 10% variability in PEF within a 7 day period.
- Must have a bronchodilator FEV1 > 40% and <80% in the past 1 year
- Current unstable asthma i.e. ACT score ≤ 19 at enrolment despite already being managed with GINA step 3-5 therapy.
- One or more courses of oral corticosteroids in the prior year, or a hospitalization or ED attendance with an asthma exacerbation in the last year
- Age 18 years or older at time of consent.
Show all 9Show fewer
- Capable of understanding and complying with the requirements of the protocol, including the ability to attend for all required visits.
- Able and willing to take inhaled medication via a Diskus.
- In the opinion of the investigator suitable for use of a salmeterol/fluticasone Diskus inhaler or already using a salmeterol/fluticasone inhaler.
Who cannot join
- Have used any investigational product or device within 3 months of the enrolment visit.
- Have known previous sensitivity to Seretide (salmeterol/fluticasone).
- Have a known significant (in the opinion of the investigator) concurrent medical disease, pregnancy that might mean that the participant cannot complete the study.
- Be taking omalizumab or other biological agent used in the treatment of asthma
- Concurrent treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors; Ketoconazole and Ritonavir.
- Current smokers and ex-smokers with a greater than 20 pack year history of cigarette smoke
Trial locations and contacts
1 site in 1 country.
Elaine MacHale, RN MSC contact
Ireland1 site, 1 recruiting
- Recruiting
Beaumont Hospital
Dublin, 9
Elaine MacHale, RN MSc, emachale@rcsi.ie
Lorna Lombard, RN, lornalombard@rcsi.ie
About this study
Official title: A Study on Inhaler Adherence to Improve Poor Asthma Control
The investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, compared to current best practice. The study has an adherence optimisation phase, week 1-12 followed by a medication management phase, week 12 to week 32.
The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
The study has two co-primary endpoints, one will be a comparison of the adherence to therapy and the other will be a comparison of the appropriateness of medication prescriptions between the two study groups.
Read the detailed description
The investigators hypothesize that aligning adherence, inhaler technique and digitally recorded PEF to inform patients and as the basis of prescribing decisions achieves better inhaler adherence and technique and also allows physicians to make appropriate prescribing decisions, compared to current best practice.
The investigators will compare two asthma education interventions, standard BTS/SIGN Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
This education phase is followed by a medication optimisation phase (weeks 12-32) in which there are 3 cycles of medication optimisation guided by a digital script. The script either adjusts the medications following the GINA recommendation or uses the GINA recommendation but is supplemented with data on adherence and PEF that are recorded to digital, time-stamped, recording devices.
The aim of the study is to improve and maintain adherence to preventer therapy, so that medication and other costs as well as the quality of life, exacerbation rates are optimal.
- Conditions
- Asthma
- Being tested
- INCA feedback, Usual Care
- Keywords
- Adherence, Inhaler, GINA
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA feedbackBehavioural
The study team have developed a device which is attached to inhalers that makes an audio recording of the inhaler being used. Analysis of this audio data provides objective evidence of the time of inhaler use, technique of use and the peak inspiratory flow the patient makes each time they use their inhaler. Our preliminary experiences with the information obtained from this device indicate that adherence is poor in patients with severe asthma due to any one the following issues poor time of use, errors in handling and low peak inspiratory flow rates.
Usual CareBehavioural
The core features of the "usual care" group are:
The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals.
Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques.
Written action plans for managing asthma, based on changes in PEF and symptoms will be given.
In follow up, medication changes in response to the above will be directed by these, as suggested by Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Routine inhaler adherence care | Placebo comparator | Normal Care group This management is based on the inhaler training recommendations of the BTS/SIGN group (http://www.brit-thoracic.org.uk/Portals/0/Guidelines/AsthmaGuidelines/sign101%20Jan%202012.pdf) and medication management of the GINA management strategy.
The core features of the "usual care" group are:
1. The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals.
2. Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques.
3. Written action plans for managing asthma, based on changes in PEF and symptoms will be given.
4. In follow up, medication changes in response to the above will be directed by these, as suggested by GINA management guidelines using a standardised digital script. Receives: Behavioral: Usual Care |
| INCA feedback | Active comparator | 1. The patient's treatment goal is established and used as the focus of the conversation.
2. Data from the INCA device including (1) time of use, (2) handling proficiency and (3) inhalation flow rates are discussed, with three graphs as shown in the appendix and derived as discussed. These are aimed to enhance the value of the inhaler.
3. Data from the electronic PEF and AQLQ are correlated with digitally recorded adherence so that these can be used to account for improvements or declines in these measures.
4. In follow up, medication changes in response to the above (adherence, PEF, ACT and exacerbations) are made using a standardised digital script. Receives: Behavioral: INCA feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean rate of actual Adherence to preventer medication
This study will focus on severe asthma patients, who remain uncontrolled and with frequent exacerbations requiring oral steroids and have an Asthma control test (ACT) score of <19 on enrollment.
Measured: week 20 through 32
The between-group difference in the proportion of patients prescribed guideline appropriate medication at the end of the study.
The appropriateness of the prescribed therapy will be verified for each participant after study completion using all available adherence and PEF data.
Between-group differences will be further broken down by the following:
- The proportion of participants prescribed add-on therapy (e.g. Monoclonal antibody therapy)
- The proportion of participants whose ICS/LABA dose was increased
- The proportion of participants whose ICS/LABA dose was reduced
Measured: week 20 through 32
Secondary outcomes (10)
Cost-effectiveness and economic evaluation of the INCA educational intervention
An economic evaluation of national implementation of the INCA-SUN program will be provided. Data on the cost of the intervention (device, time taken to deliver, cost of training and salary cost of the trainer), medication costs, quality of life, exacerbations and other healthcare utilization and associated costs, such as unscheduled health care visits as well as work productivity losses will be collected alongside the 32-week study.
A cost-effectiveness and cost-utility analysis of the intervention compared to the control arm will be performed. Incremental cost-effectiveness ratios (or ICERS) will be calculated from the data, to estimate how much additional cost is required for an additional unit of benefit.
Measured: First 8 weeks of the study and week 20 to 32
Change in Asthma Control Test scores at week 32
ACT scores will be obtained during the study visits.
Measured: Baseline to week 32
Change in PEF variability
Differences between the two study groups will be calculated
Measured: Baseline to week 32
Change in AQLQ
AQLQ scores will be obtained during the study visits.
Measured: Baseline to week 32
Exacerbations over study period
It is hypothesised that with active education, exacerbation frequency can be reduced.
Measured: Baseline to week 32
To compare the proportion of patients who were clinically stable
The proportion of patients who required no daily reliever use in the month prior to study end will be compared.
Measured: First 8 weeks of the study and week 20 to 32
Relationship of biomarkers with adherence
A comparison of changes in blood eosinophil's, periostin and Fractional Exhaled Nitric Oxide (FeNO) between the active and control groups will be made.The relationship between 7-day FeNO suppression and clinical and biomarker outcomes will be investigated.10. The relationship between changes in FeNO (characterised into FeNo>45ppb Or FeNO<45ppb) and adherence will also be investigated.
Measured: Baseline to week 32
The proportion of patients who are refractory to treatment
A comparison of the proportion of patients who are refractory, (defined as having actual adherence ≥80%, ≥1 exacerbation, PEF am/pm <80% and ACT ≤19) will be conducted.
Measured: First 8 weeks of the study and week 20 to 32
The proportion of patients who are non-adherent and remain uncontrolled
The proportion of patients who are non-adherent and remain uncontrolled, (i.e. Actual Adherence <80%, PEF am/pm <80% and ACT≤19) between the active and control groups will be compared.
Measured: First 8 weeks of the study and week 20 to 32
The proportion of patients with inhaler related side effects
The proportion of patients with inhaler related side effects including oral candidiasis between the active and control groups will be compared.
Measured: First 8 weeks of the study and week 20 to 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2015
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Dec 2020 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaumont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Richard Costello, Beaumont Hospital
- Investigators
- Richard w Costello, MD, Principal investigator, RCSI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307669
- Sponsor's protocol ID
- INCA-Sun
- Acronym
- INCA-SUN
- Status last verified
- Aug 2019
- First submitted
- 21 Apr 2014
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mokoka MC, Lombard L, MacHale EM, Walsh J, Cushen B, Sulaiman I, Carthy DM, Boland F, Doyle F, Hunt E, Murphy DM, Faul J, Butler M, Hetherington K, Mark FitzGerald J, Boven JFV, Heaney LG, Reilly RB, Costello RW. In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial. BMJ Open. 2017 Jun 15;7(6):e015367. doi: 10.1136/bmjopen-2016-015367.
PubMed 28619778Hale EM, Greene G, Mulvey C, Mokoka MC, van Boven JFM, Cushen B, Sulaiman I, Brennan V, Lombard L, Walsh J, Plunkett S, McCartan TA, Kerr PJ, Reilly RB, Hughes C, Kent BD, Jackson DJ, Butler M, Counihan I, Hayes J, Faul J, Kelly M, Convery R, Nanzer AM, Fitzgerald JM, Murphy DM, Heaney LG, Costello RW; INCA Research Team. Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma (INCA Sun): a multicentre, single-blinded, randomised clinical trial. Lancet Respir Med. 2023 Jul;11(7):591-601. doi: 10.1016/S2213-2600(22)00534-3. Epub 2023 Mar 21.
PubMed 36963417Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704.
PubMed 33369570
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Inhaler Adherence to Improve Poor Asthma Control
- ClinicalTrials.gov ID
- NCT02307669
- Acronym / sponsor ID
- INCA-SUN / INCA-Sun
- Conditions
- Asthma
- Keywords
- Adherence, Inhaler, GINA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Beaumont HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Dec 2014 (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 investigators hypothesize that aligning digital data on PEF and adherence with the patient's own clinical course achieves better asthma control and identifies risks for future loss of control, compared to current best practice. The study has an adherence optimisation phase, week 1-12 followed by a medication management phase, week 12 to week 32.
The investigators will compare two asthma education interventions, standard Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
The study has two co-primary endpoints, one will be a comparison of the adherence to therapy and the other will be a comparison of the appropriateness of medication prescriptions between the two study groups.
Detailed description
The investigators hypothesize that aligning adherence, inhaler technique and digitally recorded PEF to inform patients and as the basis of prescribing decisions achieves better inhaler adherence and technique and also allows physicians to make appropriate prescribing decisions, compared to current best practice.
The investigators will compare two asthma education interventions, standard BTS/SIGN Guideline recommended practice and feedback from the individual's own INCA device, which assesses inhaler adherence and relates adherence with changes in PEF and symptom scores over time.
This education phase is followed by a medication optimisation phase (weeks 12-32) in which there are 3 cycles of medication optimisation guided by a digital script. The script either adjusts the medications following the GINA recommendation or uses the GINA recommendation but is supplemented with data on adherence and PEF that are recorded to digital, time-stamped, recording devices.
The aim of the study is to improve and maintain adherence to preventer therapy, so that medication and other costs as well as the quality of life, exacerbation rates are optimal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine inhaler adherence care | Placebo comparator | Behavioral: Usual CareNormal Care group This management is based on the inhaler training recommendations of the BTS/SIGN group (http://www.brit-thoracic.org.uk/Portals/0/Guidelines/AsthmaGuidelines/sign101%20Jan%202012.pdf) and medication management of the GINA management strategy. The core features of the "usual care" group are: 1. The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals. 2. Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques. 3. Written action plans for managing asthma, based on changes in PEF and symptoms will be given. 4. In follow up, medication changes in response to the above will be directed by these, as suggested by GINA management guidelines using a standardised digital script. |
| INCA feedback | Active comparator | Behavioral: INCA feedback1. The patient's treatment goal is established and used as the focus of the conversation. 2. Data from the INCA device including (1) time of use, (2) handling proficiency and (3) inhalation flow rates are discussed, with three graphs as shown in the appendix and derived as discussed. These are aimed to enhance the value of the inhaler. 3. Data from the electronic PEF and AQLQ are correlated with digitally recorded adherence so that these can be used to account for improvements or declines in these measures. 4. In follow up, medication changes in response to the above (adherence, PEF, ACT and exacerbations) are made using a standardised digital script. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must be willing to give voluntary informed consent
- Must have a clinical diagnosis of asthma supported by objective measures, one of the following by FEV1/FVC <70% and FEV1 <80% or - a 12% change in FEV1 following administration of a beta-agonist or spontaneously over 1 year period, a positive bronchial provocation test, or a 10% variability in PEF within a 7 day period.
- Must have a bronchodilator FEV1 > 40% and <80% in the past 1 year
- Current unstable asthma i.e. ACT score ≤ 19 at enrolment despite already being managed with GINA step 3-5 therapy.
- One or more courses of oral corticosteroids in the prior year, or a hospitalization or ED attendance with an asthma exacerbation in the last year
Key exclusion criteria (6 listed)
- Have used any investigational product or device within 3 months of the enrolment visit.
- Have known previous sensitivity to Seretide (salmeterol/fluticasone).
- Have a known significant (in the opinion of the investigator) concurrent medical disease, pregnancy that might mean that the participant cannot complete the study.
- Be taking omalizumab or other biological agent used in the treatment of asthma
- Concurrent treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors; Ketoconazole and Ritonavir.
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 |
|---|---|---|
| INCA feedbackThe study team have developed a device which is attached to inhalers that makes an audio recording of the inhaler being used. Analysis of this audio data provides objective evidence of the time of inhaler use, technique of use and the peak inspiratory flow the patient makes each time they use their inhaler. Our preliminary experiences with the information obtained from this device indicate that adherence is poor in patients with severe asthma due to any one the following issues poor time of use, errors in handling and low peak inspiratory flow rates. | Behavioural | INCA feedback |
| Usual CareThe core features of the "usual care" group are: The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals. Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques. Written action plans for managing asthma, based on changes in PEF and symptoms will be given. In follow up, medication changes in response to the above will be directed by these, as suggested by Guidelines. | Behavioural | Routine inhaler adherence care |
Primary outcome
Mean rate of actual Adherence to preventer medication
Time frame: week 20 through 32
This study will focus on severe asthma patients, who remain uncontrolled and with frequent exacerbations requiring oral steroids and have an Asthma control test (ACT) score of <19 on enrollment.
The between-group difference in the proportion of patients prescribed guideline appropriate medication at the end of the study.
Time frame: week 20 through 32
The appropriateness of the prescribed therapy will be verified for each participant after study completion using all available adherence and PEF data. Between-group differences will be further broken down by the following: * The proportion of participants prescribed add-on therapy (e.g. Monoclonal antibody therapy) * The proportion of participants whose ICS/LABA dose was increased * The proportion of participants whose ICS/LABA dose was reduced
10 secondary outcomes
Cost-effectiveness and economic evaluation of the INCA educational intervention
Time frame: First 8 weeks of the study and week 20 to 32
Change in Asthma Control Test scores at week 32
Time frame: Baseline to week 32
Change in PEF variability
Time frame: Baseline to week 32
Change in AQLQ
Time frame: Baseline to week 32
Exacerbations over study period
Time frame: Baseline to week 32
To compare the proportion of patients who were clinically stable
Time frame: First 8 weeks of the study and week 20 to 32
Relationship of biomarkers with adherence
Time frame: Baseline to week 32
The proportion of patients who are refractory to treatment
Time frame: First 8 weeks of the study and week 20 to 32
The proportion of patients who are non-adherent and remain uncontrolled
Time frame: First 8 weeks of the study and week 20 to 32
The proportion of patients with inhaler related side effects
Time frame: First 8 weeks of the study and week 20 to 32
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Background: PubMed 28619778Mokoka MC, Lombard L, MacHale EM, Walsh J, Cushen B, Sulaiman I, Carthy DM, Boland F, Doyle F, Hunt E, Murphy DM, Faul J, Butler M, Hetherington K, Mark FitzGerald J, Boven JFV, Heaney LG, Reilly RB, Costello RW. In patients with severe uncontrolled asthma, does knowledge of adherence and inhaler technique using electronic monitoring improve clinical decision making? A protocol for a randomised controlled trial. BMJ Open. 2017 Jun 15;7(6):e015367. doi: 10.1136/bmjopen-2016-015367.
- Derived from this study: PubMed 36963417Hale EM, Greene G, Mulvey C, Mokoka MC, van Boven JFM, Cushen B, Sulaiman I, Brennan V, Lombard L, Walsh J, Plunkett S, McCartan TA, Kerr PJ, Reilly RB, Hughes C, Kent BD, Jackson DJ, Butler M, Counihan I, Hayes J, Faul J, Kelly M, Convery R, Nanzer AM, Fitzgerald JM, Murphy DM, Heaney LG, Costello RW; INCA Research Team. Use of digital measurement of medication adherence and lung function to guide the management of uncontrolled asthma (INCA Sun): a multicentre, single-blinded, randomised clinical trial. Lancet Respir Med. 2023 Jul;11(7):591-601. doi: 10.1016/S2213-2600(22)00534-3. Epub 2023 Mar 21.
- Derived from this study: PubMed 33369570Butler CA, Heaney LG. Fractional exhaled nitric oxide and asthma treatment adherence. Curr Opin Allergy Clin Immunol. 2021 Feb 1;21(1):59-64. doi: 10.1097/ACI.0000000000000704.
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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.
Elaine MacHale, RN MSC contact
Richard w Costello, MD principal investigator
RCSI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INCA feedback in people with Asthma, run by Beaumont Hospital at 1 site in Ireland.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Aug 2019. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elaine MacHale, RN MSC (emachale@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean rate of actual Adherence to preventer medication (time frame: week 20 through 32). The study lists 2 primary outcomes in all. 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 NCT02307669, 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 16 Aug 2019.