AsthmaPhase 2NCT01122680
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma
A Phase 2 study testing Tiotropium bromide in people with Asthma, run by Boehringer Ingelheim at 19 sites in 5 countries.
Trial summary
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tiotropium bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 19 sitesin 5 countries
- Study dates
- May 2010to Apr 2011
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients and legally accepted caregiver(s) must sign and date an Informed Consent form consistent with Good Clinical Practice (GCP) guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and local legislation prior to participation in the trial.
- Male or female patients between 12 and 17 years of age.
- All patients must have at least a 3 months history of asthma and fulfill the diagnostic criteria of moderate persistent asthma, according to the current Global Initiative for Asthma (GINA) guidelines at the time of enrolment into the trial.
- All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of equal or above 1.5.
- All patients must have a pre-bronchodilator FEV1 above 60% and less than or equal 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
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- All patients must have an increase in FEV1 of equal or above 12% and 200 mL 15 min. after 400 mcg salbutamol (albuterol) at Visit 1. If patients in the lower age range (e.g., 12 to 14 year olds) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (12%) post-bronchodilator response.
- All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
- Patients should be able to use the Respimat® inhaler correctly.
- Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres, according to American Thoracic Society (ATS) standards and the use of the electronic diary/peak flow meter.
Who cannot join
- Patients with a significant disease other than asthma.
- Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention (e. g. pacemaker implantation) or a change in drug therapy within the past year.
- Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
- Patients with lung diseases other than asthma, e.g. cystic fibrosis (CF). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia (BPD) will be regarded as exclusion criterion
- Patients with significant alcohol or drug abuse within the past two years.
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- Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA) or any other components of the tiotropium inhalation solution.
- Pregnant or nursing adolescent female patients, including female patients with a positive Beta HCG (serum pregnancy) testing at screening (visit 1).
- Sexually active female patients of child-bearing potential not using a highly effective method of birth control.
- Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
- Patients with renal impairment, as defined by a creatinine clearance less than 50 mL/min/1.73 m2 body surface area (BSA) as calculated by Schwartz Formula.
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States5 sites
205.424.01004 Boehringer Ingelheim Investigational Site
Boys Town, Nebraska
205.424.01001 Boehringer Ingelheim Investigational Site
Canton, Ohio
205.424.01006 Boehringer Ingelheim Investigational Site
Columbia, Missouri
205.424.01002 Boehringer Ingelheim Investigational Site
Denver, Colorado
205.424.01007 Boehringer Ingelheim Investigational Site
Warrensburg, Missouri
Latvia5 sites
205.424.37104 Boehringer Ingelheim Investigational Site
Balvi
205.424.37103 Boehringer Ingelheim Investigational Site
Daugavpils
205.424.37105 Boehringer Ingelheim Investigational Site
Rēzekne
205.424.37101 Boehringer Ingelheim Investigational Site
Riga
205.424.37102 Boehringer Ingelheim Investigational Site
Riga
Germany3 sites
205.424.49007 Boehringer Ingelheim Investigational Site
Koblenz
205.424.49004 Boehringer Ingelheim Investigational Site
Rosenheim
205.424.49002 Boehringer Ingelheim Investigational Site
Wesel
Lithuania3 sites
205.424.37001 Boehringer Ingelheim Investigational Site
Vilnius
205.424.37003 Boehringer Ingelheim Investigational Site
Vilnius
205.424.37004 Boehringer Ingelheim Investigational Site
Vilnius
Slovenia3 sites
205.424.38604 Boehringer Ingelheim Investigational Site
Kamnik
205.424.38605 Boehringer Ingelheim Investigational Site
Ljubljana
205.424.38602 Boehringer Ingelheim Investigational Site
Maribor
About this study
Official title: A Phase II Randomised, Double-blind, Placebo-controlled, Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Adolescents (12 to 17 Yrs Old) With Moderate Persistent Asthma
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
- Conditions
- Asthma
- Being tested
- Tiotropium bromide, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium bromideDrug
inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg)
tiotropium bromideDrug
inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg)
tiotropium bromideDrug
inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg)
PlaceboDrug
placebo inhalation solution
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | patients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler Receives: Drug: Tiotropium bromide |
| Treatment C | Experimental | patients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler Receives: Drug: tiotropium bromide |
| Placebo | Placebo comparator | patients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler Receives: Drug: Placebo |
| Treatment B | Experimental | patients inhale 2 puffs (dose of 2.5 mcg) once daily in the evening via Respimat inhaler Receives: Drug: tiotropium bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume (FEV1) Peak (0-3h) Response
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Secondary outcomes (13)
Trough FEV1 Response
The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response
FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FEV1 Individual Measurements Response at Each Time-point
Individual FEV1 measurements at each time-point ("personal best"). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Forced Vital Capacity (FVC) Peak (0-3h) Response
The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FVC Trough Response
The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response
FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FVC Individual Measurements at Each Time-point
Individual FVC measurements at each time-point ("personal best"). Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point
FEF 25-75% is the mean forced expiratory flow between 25% and 75% of the FVC determined at the end of the 4-week treatment period. This is often referred to as the maximum midexpiratory flow. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Mean Morning Peak Expiratory Flow (PEF) Response
Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Mean Evening PEF Response
Mean evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Change From Baseline in the Number of Puffs of Rescue Medication Per Day
Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)
ACQ is a questionnaire consisting of a seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: 4 weeks
Change From Baseline in Mean Number of Nighttime Awakenings
Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and last week of treatment (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
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.
- 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 Boehringer IngelheimThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122680
- Sponsor's protocol ID
- 205.424
- Other IDs
- 2009-017745-55, 2009
- Status last verified
- Jul 2012
- First submitted
- 11 May 2010
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Vogelberg C, Engel M, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Downie J, Nething K, Vevere V, Vandewalker M. Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: a randomised dose-ranging study. Respir Med. 2014 Sep;108(9):1268-76. doi: 10.1016/j.rmed.2014.06.011. Epub 2014 Jul 17.
PubMed 25081651
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double-blind, Placebo-controlled, Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Adolescents (12 to 17 Yrs Old) With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01122680
- Acronym / sponsor ID
- 205.424
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 27 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the efficacy and safety of tiotropium 1.25 mcg (2 actuations of 0.625 mcg), tiotropium 2.5 mcg (2 actuations of 1.25 mcg) and tiotropium 5 mcg (2 actuations of 2.5 mcg) once daily in the evening delivered by the Respimat inhaler in adolescents (12 to 17 yrs) with moderate persistent asthma, compared to placebo and on top of maintenance therapy with an inhaled corticosteroid controller medication. It is a randomised, double-blind, placebo-controlled Phase II trial with incomplete cross-over design. Patients need to be still symptomatic, i. e. not fully controlled with their maintenance treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Tiotropium bromidepatients inhale 2 puffs (dose of 1.25 mcg) once daily in the evening via Respimat inhaler |
| Treatment C | Experimental | Drug: tiotropium bromidepatients inhale 2 puffs (dose of 5 mcg) once daily in the evening via Respimat inhaler |
| Placebo | Placebo comparator | Drug: Placebopatients inhale 2 puffs of placebo matching tiotropium once daily in the evening via Respimat inhaler |
| Treatment B | Experimental | Drug: tiotropium bromidepatients inhale 2 puffs (dose of 2.5 mcg) once daily in the evening via Respimat inhaler |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- All patients and legally accepted caregiver(s) must sign and date an Informed Consent form consistent with Good Clinical Practice (GCP) guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and local legislation prior to participation in the trial.
- Male or female patients between 12 and 17 years of age.
- All patients must have at least a 3 months history of asthma and fulfill the diagnostic criteria of moderate persistent asthma, according to the current Global Initiative for Asthma (GINA) guidelines at the time of enrolment into the trial.
- All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of equal or above 1.5.
Key exclusion criteria (11 listed)
- Patients with a significant disease other than asthma.
- Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention (e. g. pacemaker implantation) or a change in drug therapy within the past year.
- Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
- Patients with lung diseases other than asthma, e.g. cystic fibrosis (CF). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia (BPD) will be regarded as exclusion criterion
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 |
|---|---|---|
| Tiotropium bromideinhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg) | Drug | Treatment A |
| tiotropium bromideinhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg) | Drug | Treatment B |
| tiotropium bromideinhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg) | Drug | Treatment C |
| Placeboplacebo inhalation solution | Drug | Placebo |
Primary outcome
Forced Expiratory Volume (FEV1) Peak (0-3h) Response
Time frame: Baseline and 4 weeks
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
13 secondary outcomes
Trough FEV1 Response
Time frame: Baseline and 4 weeks
FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response
Time frame: Baseline and 4 weeks
FEV1 Individual Measurements Response at Each Time-point
Time frame: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Forced Vital Capacity (FVC) Peak (0-3h) Response
Time frame: Baseline and 4 weeks
FVC Trough Response
Time frame: Baseline and 4 weeks
FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response
Time frame: Baseline and 4 weeks
FVC Individual Measurements at Each Time-point
Time frame: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Forced Expiratory Flow (FEF) 25-75% Individual Measurements Response at Each Time Point
Time frame: Baseline and 4 weeks (10 min pre-dose, 30 min, 1,2,3 hours post-dose)
Mean Morning Peak Expiratory Flow (PEF) Response
Time frame: Baseline and 4 weeks
Mean Evening PEF Response
Time frame: Baseline and 4 weeks
Change From Baseline in the Number of Puffs of Rescue Medication Per Day
Time frame: Baseline and 4 weeks
Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)
Time frame: 4 weeks
Change From Baseline in Mean Number of Nighttime Awakenings
Time frame: Baseline and last week of treatment (week 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25081651Vogelberg C, Engel M, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Downie J, Nething K, Vevere V, Vandewalker M. Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: a randomised dose-ranging study. Respir Med. 2014 Sep;108(9):1268-76. doi: 10.1016/j.rmed.2014.06.011. Epub 2014 Jul 17.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium bromide in people with Asthma, run by Boehringer Ingelheim at 19 sites in 5 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 11 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Latvia, Germany, Lithuania, Slovenia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 27 Jun 2012). 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?
Forced Expiratory Volume (FEV1) Peak (0-3h) Response (time frame: Baseline and 4 weeks). 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 NCT01122680, 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 16 May 2014.