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Chronic Obstructive Pulmonary Disease (COPD)Phase 3INTRUST2NCT00877383

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 176 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Indacaterol 150 μg and Tiotropium 18 μg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,142 participants
Where
176 sitesin 9 countries
Study dates
Apr 2009to Feb 2010
Phase
Phase 3
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
  • Smoking history of at least 10 pack-years
  • Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
  • Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Who cannot join

  • Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions
  • Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

176 sites in 9 countries.

176 sites in 9 countries

United States116 sites

  • Novartis Investigative Site

    Abingdon, Virginia, 24210

  • Novartis Investigative Site

    Akron, Ohio, 44313

  • Novartis Investigative Site

    Allentown, Pennsylvania, 18103

  • Novartis Investigator Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Bayside, New York, 11361

  • Novartis Investigative Site

    Beaver, Pennsylvania, 15009

  • Novartis Investigator Site

    Bellevue, Nebraska, 68005

  • Novartis Investigator Site

    Billings, Montana, 59102

  • Novartis Investigator Site

    Birmingham, Alabama, 35249-2181

  • Novartis Investigator Site

    Boulder, Colorado, 80304

  • Novartis Investigative Site

    Brick, New Jersey, 08723

  • Novartis Investigator Site

    Buena Park, California, 90620

  • Novartis Investigative Site

    Burlington, Massachusetts, 01803

  • Novartis Investigative Site

    Burlington, North Carolina, 27215

  • Novartis Investigator Site

    Centennial, Colorado, 80112

  • Novartis Investigator Site

    Charleston, South Carolina, 29407

  • Novartis Investigator Site

    Charlotte, North Carolina, 28207

  • Novartis Investigator Site

    Charlotte, North Carolina, 28277

  • Novartis Investigator Site

    Chaska, Minnesota, 55318

  • Novartis Investigator Site

    Cincinnati, Ohio, 45231

  • Novartis Investigator Site

    Cincinnati, Ohio, 45242

  • Novartis Investigator Site

    Clearwater, Florida, 33765

  • Novartis Investigator Site

    Cleveland, Ohio, 44109

  • Novartis Investigator Site

    Colorado Springs, Colorado, 80907

  • Novartis Investigator Site

    Columbia, Missouri, 65212

  • Novartis Investigator Site

    Couer D'Alene, Idaho, 98314

  • Novartis Investigator Site

    Crescent Springs, Kentucky, 41017

  • Novartis Investigator Site

    Dallas, Texas, 75216

  • Novartis Investigator Site

    Dallas, Texas, 75246

  • Novartis Investigator Site

    Denver, Colorado, 80206

  • Novartis Investigator Site

    Destin, Florida, 32541

  • Novartis Investigator Site

    Downers Grove, Illinois, 60515

  • Novartis Investigator Site

    Easley, South Carolina, 26940

  • Novartis Investigator Site

    Edina, Minnesota, 55435

  • Novartis Investigator Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Erie, Pennsylvania, 16506

  • Novartis Investigator Site

    Eugene, Oregon, 97401

  • Novartis Investigator Site

    Fargo, North Dakota, 58103

  • Novartis Investigator Site

    Fort Worth, Texas, 76109

  • Novartis Investigative Site

    Fredericks, Virginia, 22401

  • Novartis Investigator Site

    Fullerton, California, 92835

  • Novartis Investigative Site

    Glastonbury, Connecticut, 06033

  • Novartis Investigator Site

    Glendale, Arizona, 85306

  • Novartis Investigator Site

    Grand Forks, North Dakota, 58201

  • Novartis Investigative Site

    Great Neck, New York, 11023

  • Novartis Investigator Site

    Greenville, South Carolina, 29615

  • Novartis Investigator Site

    Henderson, Nevada, 89014

  • Novartis Investigator Site

    Houston, Texas, 77030

  • Novartis Investigator Site

    Jasper, Alabama, 35501

  • Novartis Investigator Site

    Kalispell, Montana, 59901

  • Novartis Investigator Site

    Kansas City, Missouri, 64128

  • Novartis Investigative site

    Larchmont, New York, 10538

  • Novartis Investigator Site

    Lexington, Kentucky, 40504

  • Novartis Investigator Site

    Lincoln, Nebraska, 68516

  • Novartis Investigator Site

    Little Rock, Arkansas, 72205

  • Novartis Investigator Site

    Louisville, Kentucky, 40202

  • Novartis Investigator Site

    Maitland, Florida, 32751

  • Novartis Investigator Site

    Miami, Florida, 33125

  • Novartis Investigator Site

    Miami Beach, Florida, 33140

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55402

  • Novartis Investigator Site

    Mission Viejo, California, 92691

  • Novartis Investigator Site

    Mobile, Alabama, 36608-1128

  • Novartis Investigative Site

    Morgantown, West Virginia, 26505

  • Novartis Investigative Site

    New Brunswick, New Jersey, 08902

  • Novartis Investigator Site

    North Charleston, South Carolina, 29406-7108

  • Novartis Investigator Site

    Ocala, Florida, 34471

  • Novartis Investigative Site

    Ocean City, New Jersey, 07712

  • Novartis Investigator Site

    Oklahoma City, Oklahoma, 73104

  • Novartis Investigator Site

    Ozark, Missouri, 65721

  • Novartis Investigator Site

    Papillion, Nebraska, 68046

  • Novartis Investigative Site

    Pawtucket, Rhode Island, 02860

  • Novartis Investigator Site

    Pensacola, Florida, 32503

  • Novartis Investigator Site

    Pensacola, Florida, 32504

  • Novartis Investigator Site

    Pensacola, Florida, 32514

  • Novartis Investigative site

    Philadelphia, Pennsylvania, 19104

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19140

  • Novartis Investigator Site

    Phoenix, Arizona, 85006

  • Novartis Investigator Site

    Phoenix, Arizona, 85013

  • Novartis Investigative Site

    Phoenixville, Pennsylvania, 19460

  • Novartis Investigator Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Providence, Rhode Island, 02903

  • Novartis Investigative Center

    Raleigh, North Carolina, 27607

  • Novartis Investigator Site

    Renton, Washington, 98055

  • Novartis Investigator Site

    River Forest, Illinois, 60305

  • Novartis Investigator Site

    Rochester, Minnesota, 55905

  • Novartis Investigator Site

    Saint Paul, Minnesota, 55130

  • Novartis Investigator Site

    Salt Lake City, Utah, 84107

  • Novartis Investigator Site

    San Ramon, California, 94583

  • Novartis Investigator Site

    Santa Barbara, California, 93110

  • Novartis Investigator Site

    Scottsdale, Arizona, 85251

  • Novartis Investigator Site

    Sepulveda, California, 91343

  • Novartis Investigator Site

    Shawnee, Kansas, 66217

  • Novartis Investigative Site

    Shelby, North Carolina, 28150

  • Novartis Investigator Site

    Shreveport, Louisiana, 71103

  • Novartis Investigator Site

    South Miami, Florida, 33143

  • Novartis Investigator Site

    Spartanburg, South Carolina, 29303

  • Novartis Investigator Site

    Spokane, Washington, 99204

  • Novartis Investigator Site

    Spring Valley, California, 91978

  • Novartis Investigator Site

    Springfield, Illinois, 62781

  • Novartis Investigator Site

    St Louis, Missouri, 63110

  • Novartis Investigator Site

    St Louis, Missouri, 63141

  • Novartis Investigator Site

    St Louis, Missouri, 63317

  • Novartis Investigator Site

    Statesville, North Carolina, 28625

  • Novartis Investigator Site

    Tamarac, Florida, 33321

  • Novartis Investigator Site

    Tampa, Florida, 33603

  • Novartis Investigator Site

    Tampa, Florida, 33613

  • Novartis Investigator Site

    Toledo, Ohio, 43608

  • Novartis Investigator Site

    Torrance, California, 90502

  • Novartis Investigator Site

    Torrance, California, 90505

  • Novartis Investigator Site

    Troy, Michigan, 48085

  • Novartis Investigator Site

    Tyler, Texas, 75708

  • Novartis Investigator Site

    Union, South Carolina, 29379

  • Novartis Investigator Site

    Vista, California, 92083

  • Novartis Investigative Site

    Waldorf, Maryland, 20602

  • Novartis Investigative Site

    Waterbury, Connecticut, 06708

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada12 sites

  • Novartis Investigator Site

    Gatineau

  • Novartis Investigator Site

    Joliette

  • Novartis Investigator Site

    Mirabel

  • Novartis Investigator Site

    Mississauga

  • Novartis Investigator Site

    Montreal

  • Novartis Investigative Site

    Québec

  • Novartis Investigator Site

    Saint-Jérôme

  • Novartis Investigator Site

    Sainte-Foy

  • Novartis Investigator Site

    Sherbrooke

  • Novartis Investigator Site

    Toronto

  • Novartis Investigator Site

    Trois-Rivières

  • Novartis Investigator Site

    Windsor

Other trials in Canada

Spain10 sites

  • Novartis Investigative Site

    Alicante

  • Novartis Investigative Site

    Almería

  • Novartis Investigative Site

    Barakaldo

  • Novartis Investigator Site

    Madrid

  • Novartis Investigative Site

    Palma de Mallorca

  • Novartis Investigator Site

    Pozuelo de Alarcón

  • Novartis Investigator Site

    Riudecols

  • Novartis Investigative Site

    San Boi de Llobregat

  • Novartis Investigator Site

    Seville

  • Novartis Investigative Site

    Vilassar de Mar

Other trials in Spain

India9 sites

  • Novartis Investigator Site

    Ahmedabad

  • Novartis Investigator Site

    Bangalore

  • Novartis Investigator Site

    Coimbatore

  • Novartis Investigative Site

    Hyderabad

  • Novartis Investigative Site

    Indore

  • Novartis Investigative Site

    Jaipur

  • Novartis Investigator Site

    Ludhiana

  • Novartis Investigative Site

    Panjim

  • Novartis Investigator Site

    Trivandrum

Other trials in India

Slovakia8 sites

  • Novartis Investigative Site

    Banská Bystrica

  • Novartis Investigative Site

    Bardejov

  • Novartis Investigative Site

    Bratislava

  • Novartis Investigator Site

    Bratislava

  • Novartis Investigative Site

    Martin

  • Novartis Investigative Site

    Poprad

  • Novartis Investigative Site

    Považská Bystrica

  • Novartis Investigative Site

    Štúrovo

Other trials in Slovakia

Czechia7 sites

  • Novartis Investigative Site

    Karlovy Vary

  • Novartis Investigative Site

    Kladno

  • Novartis Investigative Site

    Kroměříž

  • Novartis Investigative SIte

    Liberec

  • Novartis Investigative Site

    Rokycany

  • Novartis Investigative Site

    Strakonice

  • Novartis Investigative Site

    Třebíč

Other trials in Czechia

Netherlands6 sites

  • Novartis Investigative Site

    Almelo

  • Novartis Investigative Site

    Breda

  • Novartis Investigative Site

    Heerlen

  • Novartis Investigative Site

    Helmond

  • Novartis Investigative Site

    Veldhoven

  • Novartis Investigative Site

    Zutphen

Other trials in Netherlands

Colombia4 sites

  • Novartis Investigative Site

    Armenia

  • Novartis Investigator Site

    Barranquilla

  • Novartis Investigative Site

    Bogotá

  • Novartis Investigator Site

    Cali

Other trials in Colombia

Hungary4 sites

  • Novartis Investigative Site

    Érd

  • Novartis Investigative Site

    Füzesabony

  • Novartis Investigator Site

    Győr

  • Novartis Investgative Site

    Százhalombatta

Other trials in Hungary

About this study

Official title: A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

Being tested
Indacaterol 150 μg, Tiotropium 18 μg, Placebo to indacaterol
Keywords
chronic obstructive pulmonary disease, COPD, indacaterol, tiotropium, bronchodilation
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indacaterol 150 μgDrug

    Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

  • Tiotropium 18 μgDrug

    Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).

  • Placebo to indacaterolDrug

    Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Study groups in NCT00877383
Study groupRoleWhat they receive
Indacaterol 150 μg and tiotropium 18 μgExperimentalPatients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Indacaterol 150 μg; Drug: Tiotropium 18 μg
Tiotropium 18 μgActive comparatorPatients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Receives: Drug: Tiotropium 18 μg; Drug: Placebo to indacaterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)

Secondary outcomes (5)

  1. Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: End of the study (Week 12 + 1 day, Day 85)

  2. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 8 hours post-dose on Day 1

  3. Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: 24 hours post-dose on Day 2

  4. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 4 hours post-dose on Day 1

  5. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of the Study (Week 12, Day 84)

    FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of the study (Week 12, Day 84). The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

    Measured: From 5 minutes to 4 hours post-dose at the end of the study (Week 12, Day 84)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00877383
Sponsor's protocol ID
CQAB149B2351
Acronym
INTRUST2
Status last verified
Aug 2011
First submitted
6 Apr 2009
Last updated
25 Aug 2011

Publications

  • Mahler DA, D'Urzo A, Bateman ED, Ozkan SA, White T, Peckitt C, Lassen C, Kramer B; INTRUST-1 and INTRUST-2 study investigators. Concurrent use of indacaterol plus tiotropium in patients with COPD provides superior bronchodilation compared with tiotropium alone: a randomised, double-blind comparison. Thorax. 2012 Sep;67(9):781-8. doi: 10.1136/thoraxjnl-2011-201140. Epub 2012 Apr 27.

    PubMed 22544891

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indacaterol 150 μg and Tiotropium 18 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Novartis Pharmaceuticals at 176 sites in 9 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 4 inclusion and 8 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 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in United States, Canada, Spain, India, Slovakia and 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Aug 2011). 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 in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of the Study (Week 12, Day 84) (time frame: From 5 minutes to 8 hours post-dose at the end of the study (Week 12, Day 84)). 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 NCT00877383, 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 25 Aug 2011.

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