Rhinitis, Allergic, Perennial and/or SeasonalPhase 4NCT01154153
Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
A Phase 4 study testing Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) and Claritin® Syrup in people with Rhinitis, Allergic, Perennial and/or Seasonal, run by Sanofi at 8 sites in United States.
Trial summary
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR). Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial and/or Seasonal
- What is being tested?
- Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) and Claritin® Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2010to Oct 2010
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- History of AR documented by the investigator, as follows:
- At least a 1-year clinical history (6-month history if the participant was >= 2 to < 4 years of age) of perennial allergic rhinitis (PAR); or a clinical history of seasonal allergic rhinitis (SAR) over 2 seasons and
- positive skin test (prick or intradermal) to a seasonal or perennial allergen that was present in the participant's environment at time of screening.
- Written informed consent and ability of parent/legal guardian of the participant to give a written informed consent before any study related procedures. Participants >=7 years of age (or younger according to the governing institutional review board [IRB]) had to provide a signed assent form
Who cannot join
- Concomitant medical condition that might have interfered with the administration of a nasal spray, including anatomical abnormalities of the nose, face (eg, polyposis, markedly deviated septum)
- Presence of any active, untreated, or clinically significant musculoskeletal, endocrinologic, gastrointestinal, hepatic, respiratory, cardiovascular, or neurological condition that might have interfered with the study
- Any conditions or treatment that might have affected the HPA axis or the plasma cortisol assay, including but not limited to:
- Documented disorder involving the hypothalamus, pituitary, or adrenal gland
- Current use of serotonergic, dopaminergic, adrenergic, cholinergic agonists and antagonists, opiates, immunomodulatory, hormonal drugs, and lipid-lowering agents
- Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within 3 months prior to Visit 1
Show all 17Show fewer
- Treatment with systemic corticosteroids for > 2 courses received up to 1 year before Visit 1 was exclusionary. Up to 2 courses of systemic corticosteroids, each course not exceeding 14 days, up to 1 year before Visit 1 was allowed
- Treatment with inhaled, intranasal, or high-potency topical corticosteroids within 6 weeks of Visit 1
- History of hospitalization due to asthma within 1 year before screening. Participants with mild asthma that was well-controlled without the use of inhaled corticosteroids within 6 weeks prior to Visit 1 were eligible for the study
- Any clinically significant (as determined by the investigator) abnormal laboratory test at Visit 1
- Morning serum cortisol outside the reference range at Visit 1
- Any of the following missing serum cortisol samples from the Visit-2 collection: first sample (before administration of investigational product), 20-hour sample, 24-hour sample, or any 2 consecutive samples
- Any medical condition where use of corticosteroids might have been contraindicated or could have led to disease exacerbation (eg, glaucoma, cataract, ocular herpes simplex, tuberculosis, growth retardation)
- History of hypersensitivity to corticosteroids or to the rescue medication, investigational product, or to any of their excipients
- Unresolved upper respiratory tract infection, sinus infection, or nasal candidiasis (ie, symptomatic or under treatment) within the last 2 weeks prior to Visit 1 and Visit 3
- Females of childbearing potential not protected by effective contraceptive method of birth control or were unwilling to abstain from sexual activity and/or, were unwilling or unable to test for pregnancy. Only female adolescent with onset of menses were to be checked by serum pregnancy test at Visit 1
- Pregnant female adolescent (who tested positive for pregnancy at Visit 1) The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Investigational Site Number 840003
Cypress, California, 90630
Investigational Site Number 840007
North Dartmouth, Massachusetts, 02747
Investigational Site Number 840001
Omaha, Nebraska, 68144
Investigational Site Number 840010
Plymouth, Minnesota, 55441
Investigational Site Number 840008
Raleigh, North Carolina, 27607
Investigational Site Number 840005
San Antonio, Texas, 78229
Investigational Site Number 840002
Spartanburg, South Carolina, 29307
Investigational Site Number 840006
Stockbridge, Georgia, 30281
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Children [>=2 to < 12 Years of Age] With Allergic Rhinitis (AR).
The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR).
Read the detailed description
The study consisted of a run-in single-blind screening phase (prerandomization) followed by an approximately 6-week double-blind treatment phase (postrandomization).
Total study duration per participant lasted from 7.5 to 13 weeks and consisted of:
- Screening and single-blind phases (these 2 phases ran concurrently, prerandomization) for 8 to 24 days. During the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning (1 actuation/nostril).
- Randomization to the double-blind treatment phase. Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
- Double-blind treatment phase which lasted at least 42 days and ran up to 47 days. Participants were administered either TAA-AQ nasal spray or placebo nasal spray.
- An evaluation at the end of treatment 1-3 days after completion of the double-blind phase.
- Being tested
- Placebo nasal spray, Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ), Claritin® Syrup
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo nasal sprayDrug
1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.
Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)Drug
Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
- For children who were >=2 to <6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
- For children who were >=6 yrs to <12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
Placebo nasal sprayDrug
Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
- For children who were >=2 to <6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
- For children who were >= 6 yrs to <12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
Claritin® SyrupDrug
Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | * placebo during the screening phase and
* placebo during the treatment phase.
All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. Receives: Drug: Placebo nasal spray; Drug: Claritin® Syrup |
| TAA-AQ | Experimental | * placebo during the screening phase and
* TAA-AQ (Nasacort AQ) during the treatment phase.
All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. Receives: Drug: Placebo nasal spray; Drug: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ); Drug: Claritin® Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline
Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times.
Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis.
Measured: 1-3 days prerandomization and 6 weeks postrandomization
Secondary outcomes (5)
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms).
Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase).
Measured: From 8-24 days prerandomization up to 6 weeks postrandomization
Number of Participants by Relief Level as Evaluated by the Physician
Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).
Measured: At end of study (43-50 days after randomization)
Number of Participants by Relief Level as Evaluated by the Participant
Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).
Measured: At end of study (43-50 days after randomization)
Number of Participants Using Rescue Medication
The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).
Measured: From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)
The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase
The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.
Measured: From randomization to 43-50 days postrandomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
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 Rhinitis, Allergic, Perennial and/or SeasonalStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Affairs, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154153
- Sponsor's protocol ID
- TRICA_L_04286
- Status last verified
- Jun 2012
- First submitted
- 22 Jun 2010
- Last updated
- 26 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Georges G, Kim KT, Ratner P, Segall N, Qiu C. Effect of intranasal triamcinolone acetonide on basal hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):163-70. doi: 10.2500/aap.2014.35.3728.
PubMed 24717794
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Children [>=2 to < 12 Years of Age] With Allergic Rhinitis (AR).
- ClinicalTrials.gov ID
- NCT01154153
- Acronym / sponsor ID
- TRICA_L_04286
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Jun 2010 (estimated)
- Results
- Posted 28 Oct 2011
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 was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR).
Detailed description
The study consisted of a run-in single-blind screening phase (prerandomization) followed by an approximately 6-week double-blind treatment phase (postrandomization).
Total study duration per participant lasted from 7.5 to 13 weeks and consisted of:
- Screening and single-blind phases (these 2 phases ran concurrently, prerandomization) for 8 to 24 days. During the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning (1 actuation/nostril).
- Randomization to the double-blind treatment phase. Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
- Double-blind treatment phase which lasted at least 42 days and ran up to 47 days. Participants were administered either TAA-AQ nasal spray or placebo nasal spray.
- An evaluation at the end of treatment 1-3 days after completion of the double-blind phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo nasal spray, Drug: Claritin® Syrup* placebo during the screening phase and * placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. |
| TAA-AQ | Experimental | Drug: Placebo nasal spray, Drug: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ), Drug: Claritin® Syrup* placebo during the screening phase and * TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- History of AR documented by the investigator, as follows:
- Written informed consent and ability of parent/legal guardian of the participant to give a written informed consent before any study related procedures. Participants >=7 years of age (or younger according to the governing institutional review board [IRB]) had to provide a signed assent form
Key exclusion criteria (17 listed)
- Concomitant medical condition that might have interfered with the administration of a nasal spray, including anatomical abnormalities of the nose, face (eg, polyposis, markedly deviated septum)
- Presence of any active, untreated, or clinically significant musculoskeletal, endocrinologic, gastrointestinal, hepatic, respiratory, cardiovascular, or neurological condition that might have interfered with the study
- Any conditions or treatment that might have affected the HPA axis or the plasma cortisol assay, including but not limited to:
- Any clinically significant (as determined by the investigator) abnormal laboratory test at Visit 1
- Morning serum cortisol outside the reference range at 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 |
|---|---|---|
| Placebo nasal spray1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase. | Drug | Placebo, TAA-AQ |
| Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old). * For children who were >=2 to <6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase. * For children who were >=6 yrs to <12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase. | Drug | TAA-AQ |
| Placebo nasal sprayTreatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old). * For children who were >=2 to <6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase. * For children who were >= 6 yrs to <12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase. | Drug | Placebo |
| Claritin® SyrupChildren's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label. | Drug | Placebo, TAA-AQ |
Primary outcome
Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline
Time frame: 1-3 days prerandomization and 6 weeks postrandomization
Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times. Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis.
5 secondary outcomes
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
Time frame: From 8-24 days prerandomization up to 6 weeks postrandomization
Number of Participants by Relief Level as Evaluated by the Physician
Time frame: At end of study (43-50 days after randomization)
Number of Participants by Relief Level as Evaluated by the Participant
Time frame: At end of study (43-50 days after randomization)
Number of Participants Using Rescue Medication
Time frame: From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)
The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase
Time frame: From randomization to 43-50 days postrandomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24717794Georges G, Kim KT, Ratner P, Segall N, Qiu C. Effect of intranasal triamcinolone acetonide on basal hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):163-70. doi: 10.2500/aap.2014.35.3728.
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.
Medical Affairs study director
Sanofi
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ) and Claritin® Syrup in people with Rhinitis, Allergic, Perennial and/or Seasonal, run by Sanofi at 8 sites in United States.
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 17 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 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 28 Oct 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?
Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline (time frame: 1-3 days prerandomization and 6 weeks postrandomization). 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 NCT01154153, 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 26 Jun 2012.