AsthmaPhase 1NCT01209026
Corrected QT (QTc) Study With Flucticasone Furoate and GW642444
A Phase 1 study testing Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination, Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination and Moxifloxacin 400mg in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination, Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination and Moxifloxacin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jun 2010to 4 Jan 2011
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age inclusive.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5xUpper limit of normal (ULN).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with tubal ligation or hysterectomy, and post-menopausal females. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods. All other female subjects must agree to use contraception until 4 months post-last dose.
- Body Mass Index (BMI) within 18.5-29.0 kilograms/metre2.
Show all 12Show fewer
- Capable of giving written informed consent.
- Subjects who are current non-smokers, who have not used any tobacco products in the 6 month period preceding the screening visit.
- No significant abnormality on 12-lead ECG at screening.
- A 24 hour Holter ECG at screening which shows no abnormalities that could affect study data.
- Forced Expiratory Volume in 1 second (FEV1) ≥ 85% predicted at screening.
- Subjects who are able to use the inhaler satisfactorily.
Who cannot join
- Subject is deemed unsuitable for the study.
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- History or presence of any medically significant disease or disorder, in particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
Show all 26Show fewer
- The subject has any history of breathing problems in adult life.
- Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
- Pregnant females.
- Lactating females.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
- Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the Unit.
- Positive urine cotinine test at screening.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females.
- The subject has participated in a clinical trial in the last 3 months.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days of the first dose.
- The subject has taken oral corticosteroids less than 8 weeks before the screening visit.
- History of sensitivity to any of the study medications.
- History of milk protein allergy.
- Where participation in the study would result in donation of blood or blood products in excess of 500 millilitres (mL) within a 90 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Consumption of seville oranges, pommelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo-controlled, Four-way Crossover Repeat Dose Study to Evaluate the Effect of the Inhaled Fluticasone Furoate (FF)/GW642444M Combination on Electrocardiographic Parameters, With Moxifloxacin as a Positive Control, in Healthy Subjects
A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in healthy male and female subjects. Key assessments will include 12- lead electrocardiogram (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.
Read the detailed description
This is a randomised, placebo controlled, four way crossover thorough QT study to evaluate the effect of repeat dose fluticasone furoate/GW642444M combination on the QTc interval in healthy male and female subjects. Up to 85 subjects will receive inhaled placebo and inhaled fluticasone furoate/GW642444M combination (200/25 microgram (mcg) or 800/100 mcg) and oral moxifloxacin (400 milligram (mg)). The inhaled treatments will be given double-blind once daily in the morning for 7 days with a single-blind placebo tablet also administered on Day 7. Moxifloxacin (positive control) will be given as a single-blind single dose on Day 7 in the morning with inhaled double-blind placebo administered in the morning on Days 1-7. Individual time-matched changes from baseline in QT duration corrected for heart rate by Fredericia's formula (QTcF) (difference from placebo) for fluticasone furoate/GW642444M 200/25mcg will be determined 0-24 hours (h) after dosing on Day 7 (primary endpoint). Secondary endpoints will include changes from baseline in QTcF, QT individual correction factor (QTci), QT duration corrected for heart rate by Bazett's formula (QTcB), and QT interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 800/100mcg and single dose oral moxifloxacin (400mg) and changes from baseline in QTci, QTcB, and QT interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 200/25mcg. Plasma concentrations (0-24h) and pharmacokinetic parameters of GW642444 and fluticasone furoate will also be derived.
- Conditions
- Asthma
- Being tested
- Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination, Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination, Placebo Inhaler, Moxifloxacin 400mg, Moxifloxacin placebo
- Keywords
- Fluticasone furoate (GW685698), moxifloxacin, QTc, GW642444, pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate (200 mcg)/GW642444 (25mcg) combinationDrug
Novel dry powder inhaler
Fluticasone furoate (400 mcg)/GW642444 (50mcg) combinationDrug
Novel dry powder inhaler
Placebo InhalerDrug
Matching placebo Novel dry powder inhaler. Lactose monohydrate and magnesium stearate.
Moxifloxacin 400mgDrug
Film coated oral tablet
Moxifloxacin placeboDrug
Film coated oral tablet
| Study group | Role | What they receive |
|---|---|---|
| FF/GW642444M (200/25mcg) | Experimental | Inhaled fluticasone furoate (200mcg) /GW642444M (25mcg) combination Days 1- 7; placebo tablet taken orally single dose (po SD) on Day 7. Receives: Drug: Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination; Drug: Placebo Inhaler; Drug: Moxifloxacin placebo |
| FF/GW642444M (800/100 mcg) | Experimental | Inhaled fluticasone furoate (800mcg) /GW642444M (100mcg) combination Days 1- 7; placebo tablet (po SD) on Day 7. Receives: Drug: Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination; Drug: Moxifloxacin placebo |
| Moxifloxacin | Active comparator | Inhaled placebo on Days 1-7; moxifloxacin (400mg po SD) on Day 7 Receives: Drug: Placebo Inhaler; Drug: Moxifloxacin 400mg |
| Placebo | Placebo comparator | Inhaled placebo on Days 1-7; placebo tablet (po SD) on Day 7. Receives: Drug: Placebo Inhaler; Drug: Moxifloxacin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QTcF interval at each timepoint on study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 200/25mcg as compared with time-matched placebo
Measured: Baseline and Day 7
Secondary outcomes (6)
Change from baseline in QTcF interval at each timepoint on study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 800/100mcg as compared with time-matched placebo.
Measured: Baseline and Day 7
Change from baseline in QTci and QTcB interval at each timepoint on Study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 200/25mcg and 800/100mcg as compared with time-matched placebo
Measured: Baseline and Day 7
Change from baseline in QTcF interval at each timepoint on Study Day 7 (average of at least 3 Holter ECG replicates per time point) for moxifloxacin as compared with time-matched placebo.
Measured: Baseline and Day 7
Maximal change from baseline on Day 7 for QTcF, QTci and QTcB (for all treatments)
Measured: Baseline and Day 7
Change from baseline at each timepoint on Day 7 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate (for all treatments)
Measured: Baseline and Day 7
Plasma concentrations of GW642444 and fluticasone furoate and derived pharmacokinetic parameters including maximum observed concentration(Cmax), time of occurence of Cmax (tmax), Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study start23 Jun 2010
- Primary completion4 Jan 2011
- Study completion4 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 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
- NCT01209026
- Sponsor's protocol ID
- 102936
- Status last verified
- Jun 2017
- First submitted
- 23 Sep 2010
- Last updated
- 8 Jun 2017
- Results posted
- No
- 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.
Publications
Kempsford R, Allen A, Kelly K, Saggu P, Crim C. A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects. Br J Clin Pharmacol. 2014 Mar;77(3):466-79. doi: 10.1111/bcp.12243.
PubMed 24093504
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Four-way Crossover Repeat Dose Study to Evaluate the Effect of the Inhaled Fluticasone Furoate (FF)/GW642444M Combination on Electrocardiographic Parameters, With Moxifloxacin as a Positive Control, in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01209026
- Acronym / sponsor ID
- 102936
- Conditions
- Asthma
- Keywords
- Fluticasone furoate (GW685698), moxifloxacin, QTc, GW642444, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2010 (actual)
- Primary completion
- 4 Jan 2011 (actual)
- Study completion
- 4 Jan 2011 (actual)
- First posted
- 24 Sep 2010 (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.
A randomised, placebo controlled thorough QTc study to evaluate the effect of repeat dose FF/GW642444M combination, with moxifloxacin as a positive control, on the QTc interval in healthy male and female subjects. Key assessments will include 12- lead electrocardiogram (ECG) and pharmacokinetic (PK) parameters, along with safety being assessed by blood pressure, heart rate, clinical laboratory safety tests, and collection of adverse events.
Detailed description
This is a randomised, placebo controlled, four way crossover thorough QT study to evaluate the effect of repeat dose fluticasone furoate/GW642444M combination on the QTc interval in healthy male and female subjects. Up to 85 subjects will receive inhaled placebo and inhaled fluticasone furoate/GW642444M combination (200/25 microgram (mcg) or 800/100 mcg) and oral moxifloxacin (400 milligram (mg)). The inhaled treatments will be given double-blind once daily in the morning for 7 days with a single-blind placebo tablet also administered on Day 7. Moxifloxacin (positive control) will be given as a single-blind single dose on Day 7 in the morning with inhaled double-blind placebo administered in the morning on Days 1-7. Individual time-matched changes from baseline in QT duration corrected for heart rate by Fredericia's formula (QTcF) (difference from placebo) for fluticasone furoate/GW642444M 200/25mcg will be determined 0-24 hours (h) after dosing on Day 7 (primary endpoint). Secondary endpoints will include changes from baseline in QTcF, QT individual correction factor (QTci), QT duration corrected for heart rate by Bazett's formula (QTcB), and QT interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 800/100mcg and single dose oral moxifloxacin (400mg) and changes from baseline in QTci, QTcB, and QT interval at each timepoint after 7 days dosing of fluticasone furoate/GW642444M 200/25mcg. Plasma concentrations (0-24h) and pharmacokinetic parameters of GW642444 and fluticasone furoate will also be derived.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FF/GW642444M (200/25mcg) | Experimental | Drug: Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination, Drug: Placebo Inhaler, Drug: Moxifloxacin placeboInhaled fluticasone furoate (200mcg) /GW642444M (25mcg) combination Days 1- 7; placebo tablet taken orally single dose (po SD) on Day 7. |
| FF/GW642444M (800/100 mcg) | Experimental | Drug: Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination, Drug: Moxifloxacin placeboInhaled fluticasone furoate (800mcg) /GW642444M (100mcg) combination Days 1- 7; placebo tablet (po SD) on Day 7. |
| Moxifloxacin | Active comparator | Drug: Placebo Inhaler, Drug: Moxifloxacin 400mgInhaled placebo on Days 1-7; moxifloxacin (400mg po SD) on Day 7 |
| Placebo | Placebo comparator | Drug: Placebo Inhaler, Drug: Moxifloxacin placeboInhaled placebo on Days 1-7; placebo tablet (po SD) on Day 7. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female between 18 and 65 years of age inclusive.
- Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5xUpper limit of normal (ULN).
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- A female subject is eligible to participate if she is of:
- Body Mass Index (BMI) within 18.5-29.0 kilograms/metre2.
Key exclusion criteria (26 listed)
- Subject is deemed unsuitable for the study.
- A screening Holter ECG tracing that reveals clinically concerning arrhythmias
- A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening.
- A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
- History or presence of any medically significant disease or disorder, in particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular 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 |
|---|---|---|
| Fluticasone furoate (200 mcg)/GW642444 (25mcg) combinationNovel dry powder inhaler | Drug | FF/GW642444M (200/25mcg) |
| Fluticasone furoate (400 mcg)/GW642444 (50mcg) combinationNovel dry powder inhaler | Drug | FF/GW642444M (800/100 mcg) |
| Placebo InhalerMatching placebo Novel dry powder inhaler. Lactose monohydrate and magnesium stearate. | Drug | FF/GW642444M (200/25mcg), Moxifloxacin, Placebo |
| Moxifloxacin 400mgFilm coated oral tablet | Drug | Moxifloxacin |
| Moxifloxacin placeboFilm coated oral tablet | Drug | FF/GW642444M (200/25mcg), FF/GW642444M (800/100 mcg), Placebo |
Primary outcome
Change from baseline in QTcF interval at each timepoint on study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 200/25mcg as compared with time-matched placebo
Time frame: Baseline and Day 7
6 secondary outcomes
Change from baseline in QTcF interval at each timepoint on study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 800/100mcg as compared with time-matched placebo.
Time frame: Baseline and Day 7
Change from baseline in QTci and QTcB interval at each timepoint on Study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 200/25mcg and 800/100mcg as compared with time-matched placebo
Time frame: Baseline and Day 7
Change from baseline in QTcF interval at each timepoint on Study Day 7 (average of at least 3 Holter ECG replicates per time point) for moxifloxacin as compared with time-matched placebo.
Time frame: Baseline and Day 7
Maximal change from baseline on Day 7 for QTcF, QTci and QTcB (for all treatments)
Time frame: Baseline and Day 7
Change from baseline at each timepoint on Day 7 for other cardiac electrophysiological parameters: QT, QRS, RR, PR and ventricular rate (for all treatments)
Time frame: Baseline and Day 7
Plasma concentrations of GW642444 and fluticasone furoate and derived pharmacokinetic parameters including maximum observed concentration(Cmax), time of occurence of Cmax (tmax), Area under the concentration-time curve over the dosing interval (AUC(0-τ))
Time frame: Study duration
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 8 Jun 2017.
- Derived from this study: PubMed 24093504Kempsford R, Allen A, Kelly K, Saggu P, Crim C. A repeat-dose thorough QT study of inhaled fluticasone furoate/vilanterol combination in healthy subjects. Br J Clin Pharmacol. 2014 Mar;77(3):466-79. doi: 10.1111/bcp.12243.
- Results for study 102936 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination, Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination and Moxifloxacin 400mg in people with Asthma, 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 12 inclusion and 26 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 8 Jun 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. 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.
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?
Change from baseline in QTcF interval at each timepoint on study Day 7 (average of at least 3 Holter ECG replicates per time point) for fluticasone furoate/GW642444M 200/25mcg as compared with time-matched placebo (time frame: Baseline and Day 7). 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 NCT01209026, which also lists 1 linked publication.
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 8 Jun 2017.