AsthmaPhase 4NCT00353873
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
A Phase 4 study testing Fluticasone propionate and Fluticasone propionate/salmeterol in people with Asthma, run by GlaxoSmithKline at 65 sites in 12 countries.
Trial summary
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate and Fluticasone propionate/salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 65 sitesin 12 countries
- Study dates
- 18 Nov 2005to 26 Oct 2006
- Phase
- Phase 4
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A documented clinical history of asthma for a period of at least 6 months.
- A documented history (within 12 months of Visit 1) of airway reversibility of = 15% based either on Forced expiratory volume (FEV1) or PEF measured pre and post inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists, patients must demonstrate a =15% reversibility at Visit 1).
- Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate HydroFluoroAlkane (HFA) non fine particle = 400-500 mcg/day or beclomethasone HFA fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day (or fluticasone 250mcg/day if subject is taking a 125mcg MDI rather than the 100mcg Diskus), for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1.
- Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be able to record the subject's maximum PEF correctly.
- Able to perform FEV1 correctly.
- Subject's guardian/parent able to complete an eDRC on behalf of the subject. The eDRC should be completed by the guardian/parent.
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- Able to use a DISKUS™ correctly.
- At least one parent(s)/guardian(s) has to give written informed consent to participate in the study.
- At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have:
- not achieved the criteria for the 'Well-controlled' asthma during two or more of the 4 weeks prior to Visit 2.
Who cannot join
- Female subjects who have reached menarche.
- Received any investigational study medication in the 4 weeks prior to Visit 1.
- Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1.
- Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
- Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks of Visit 1.
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- Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1.
- Any known clinical or laboratory evidence of a serious uncontrolled disease (including serious psychological disorders) which is, in the opinion of the investigator, likely to interfere with the study.
- Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
- A relative of any of the site staff, including the investigator or study co-coordinator.
- Has previously been entered into this study.
- Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
- Pre-bronchodilator FEV1 <60% (assuming that measurement was correctly performed).
- Any change in asthma medication (excluding use of prophylactic study specific salbutamol for prevention of asthma symptoms due to exercise).
- Respiratory tract infection or asthma exacerbation.
- Use of oral, parenteral or depot corticosteroids.
- Emergency visit due to asthma.
- Non-compliance with the completion of the eDRC (i.e. during the 4 week period between visits, non compliance is defined as less than 5 days of completed data within any one week for four weeks - subjects must complete at least 5 days a week for the entire run-in period).
Trial locations and contacts
65 sites in 12 countries.
65 sites in 12 countries
France13 sites
GSK Investigational Site
Essey-lès-Nancy, 54270
GSK Investigational Site
Grasse, 06130
GSK Investigational Site
Laon, 02000
GSK Investigational Site
Nîmes, 30900
GSK Investigational Site
Oyonnax, 01100
GSK Investigational Site
Paris, 75019
GSK Investigational Site
Paris, 75730
GSK Investigational Site
Rouen, 76000
GSK Investigational Site
Rouen, 76031
GSK Investigational Site
Saint-Michel, 16470
GSK Investigational Site
Tours, 37000
GSK Investigational Site
Vaux En Velin, 69120
GSK Investigational Site
Villejuif, 94800
Netherlands10 sites
GSK Investigational Site
Almere Stad, 1315 RA
GSK Investigational Site
Beek en Donk, 5741 CG
GSK Investigational Site
Deurne, 5751 XJ
GSK Investigational Site
Emmen, 7824 AA
GSK Investigational Site
Ermelo, 3851 EX
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Spijkenisse, 3207 NB
GSK Investigational Site
The Hague, 2517 EW
GSK Investigational Site
Tiel, 4002 WP
GSK Investigational Site
Woerden, 3447 GN
Russia9 sites
GSK Investigational Site
Krasnoyarsk, 660022
GSK Investigational Site
Moscow, 115446
GSK Investigational Site
Moscow, 119435
GSK Investigational Site
Moscow, 119991
GSK Investigational Site
Novokuznetsk, 654063
GSK Investigational Site
Novosibirsk, 630099
GSK Investigational Site
St'Petersburg, 191144
GSK Investigational Site
Syktyvkar, 167011
GSK Investigational Site
Tomsk, 634 050
Spain6 sites
GSK Investigational Site
Almería, 04009
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28009
GSK Investigational Site
San Sebastián, 20014
GSK Investigational Site
Seville, 41071
Belgium5 sites
GSK Investigational Site
Bruges, 8000
GSK Investigational Site
Brussels, 1090
GSK Investigational Site
Edegem, 2650
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Leuven, 3000
Italy4 sites
GSK Investigational Site
Foggia, Apulia, 71100
GSK Investigational Site
Naples, Campania, 80138
GSK Investigational Site
Palermo, Sicily, 90127
GSK Investigational Site
Perugia, Umbria, 06122
Poland4 sites
GSK Investigational Site
Bialystok, 15-274
GSK Investigational Site
Krakow, 31-159
GSK Investigational Site
Lodz, 93-513
GSK Investigational Site
Lublin, 20-093
Latvia3 sites
GSK Investigational Site
Daugavpils, LV5403
GSK Investigational Site
Riga, LV 1004
GSK Investigational Site
Riga, LV 1064
Lithuania3 sites
GSK Investigational Site
Kaunas, LT-50425
GSK Investigational Site
Tauragė, LT-72214
GSK Investigational Site
Vilnius, LT-10207
Norway3 sites
GSK Investigational Site
Drammen, N-3018
GSK Investigational Site
Kongsvinger, N-2226
GSK Investigational Site
Oslo, N-0855
Sweden3 sites
GSK Investigational Site
Sollentuna, SE-191 24
GSK Investigational Site
Stockholm, SE-141 86
GSK Investigational Site
Stockholm, SE-171 76
Denmark2 sites
GSK Investigational Site
Aalborg, 9000
GSK Investigational Site
Odense, 5000 Odense C
About this study
Official title: A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
Read the detailed description
A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose
- Conditions
- Asthma
- Being tested
- Fluticasone propionate, Fluticasone propionate/salmeterol
- Keywords
- FLIXOTIDE, asthmatics children 4-11 years, SERETIDE, asthma-control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionateDrug
200μg twice daily
Fluticasone propionate/salmeterolDrug
Also called Fluticasone propionate
50/100μg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone propionate (FLIXOTIDE™) | Active comparator | Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily Receives: Drug: Fluticasone propionate |
| Fluticasone propionate/salmeterol (SERETIDE™) | Experimental | Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily Receives: Drug: Fluticasone propionate/salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population
PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.
Measured: Baseline; Week 1 up to Week 12
Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population
PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.
Measured: Baseline; Week 1 up to Week 12
Secondary outcomes (2)
Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma
TC asthma is defined as no daily symptoms, no night-time wakening due to asthma, no exacerbations, no rescue salbutamol/albuterol use, no emergency visits, >=80% predicted morning PEF, and no treatment related adverse events enforcing a change in asthma therapy over 7 consecutive days. Number of participants/group who achieved the status of at least TC during the last 8 weeks (wks) of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline pre-bronchodilator Forced Expiratory Volume in one second (FEV1). Asthma control was assessed each week for the last 8 wks of treatment period. Each week was classified as 'TC', 'Well Controlled' (WC), 'Not Controlled' or 'Unevaluable'. A participant was considered to have TC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were TC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.
Measured: Week 5 up to Week 12
Number of Participants Who Achieved WC Asthma
WC asthma is defined as two or more of symptom score >1 only allowed on <=2 days/week, rescue salbutamol/albuterol use on <=2 days/week and up to a maximum of 4 times per week, >=80% predicted morning PEF daily assessed for 7 consecutive days and all the following criteria: no night-time awakening due to asthma, no exacerbations, no emergency visits, no treatment related adverse events enforcing a change in any asthma therapy. Number of participants/group who achieved the status of at least WC during the last 8 wks of treatment was analyzed using logistic regression, including covariates for sex, age, treatment group, country amalgamation and baseline prebronchodilator FEV1. Each week was classified as 'WC', 'Not Controlled' or 'Unevaluable'. A participant was considered to have WC asthma if they achieved 4/4, 5/5, 6/6, 6/7, 7/8 or 8/8 wks that were WC. 'Unevaluable' classification included participants with less than 4 wks of data during the assessment period.
Measured: Week 5 up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2006 (estimated)
- Study start18 Nov 2005
- Primary completion26 Oct 2006
- Study completion26 Oct 2006
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 AsthmaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 506 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
- NCT00353873
- Sponsor's protocol ID
- SAM104926
- Status last verified
- Mar 2018
- First submitted
- 18 Jul 2006
- Last updated
- 29 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Double Dummy, Parallel Group Study to Compare the Salmeterol/Fluticasone Propionate Combination (SeretideTM) at a Dose of 50/100µg Twice Daily and Fluticasone Propionate (FlixotideTM) at a Dose of 200µg Twice Daily, Both Delivered Via a Dry Powder Inhaler (DiskusTM) for 12 Weeks in Asthma in Children Aged 4-11 Years Not Controlled by Inhaled Corticosteroids Alone at Medium Dose
- ClinicalTrials.gov ID
- NCT00353873
- Acronym / sponsor ID
- SAM104926
- Conditions
- Asthma
- Keywords
- FLIXOTIDE, asthmatics children 4-11 years, SERETIDE, asthma-control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2005 (actual)
- Primary completion
- 26 Oct 2006 (actual)
- Study completion
- 26 Oct 2006 (actual)
- First posted
- 19 Jul 2006 (estimated)
- Results
- Posted 24 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
Detailed description
A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mcg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mcg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone propionate (FLIXOTIDE™) | Active comparator | Drug: Fluticasone propionateFluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily |
| Fluticasone propionate/salmeterol (SERETIDE™) | Experimental | Drug: Fluticasone propionate/salmeterolSalmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- A documented clinical history of asthma for a period of at least 6 months.
- A documented history (within 12 months of Visit 1) of airway reversibility of = 15% based either on Forced expiratory volume (FEV1) or PEF measured pre and post inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists, patients must demonstrate a =15% reversibility at Visit 1).
- Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate HydroFluoroAlkane (HFA) non fine particle = 400-500 mcg/day or beclomethasone HFA fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day (or fluticasone 250mcg/day if subject is taking a 125mcg MDI rather than the 100mcg Diskus), for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1.
- Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be able to record the subject's maximum PEF correctly.
- Able to perform FEV1 correctly.
Key exclusion criteria (18 listed)
- Female subjects who have reached menarche.
- Received any investigational study medication in the 4 weeks prior to Visit 1.
- Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1.
- Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
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 |
|---|---|---|
| Fluticasone propionate200μg twice daily | Drug | Fluticasone propionate (FLIXOTIDE™) |
| Fluticasone propionate/salmeterolAlso: Fluticasone propionate50/100μg twice daily | Drug | Fluticasone propionate/salmeterol (SERETIDE™) |
Primary outcome
Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population
Time frame: Baseline; Week 1 up to Week 12
PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.
Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population
Time frame: Baseline; Week 1 up to Week 12
PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.
2 secondary outcomes
Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma
Time frame: Week 5 up to Week 12
Number of Participants Who Achieved WC Asthma
Time frame: Week 5 up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
65 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone propionate and Fluticasone propionate/salmeterol in people with Asthma, run by GlaxoSmithKline at 65 sites in 12 countries.
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 18 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 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in France, Netherlands, Russia, Spain, Belgium and 7 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2017). 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?
Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population (time frame: Baseline; Week 1 up to Week 12). 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?
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 29 May 2018.