AsthmaPhase 3NCT00266851
AZMATICS: AZithroMycin/Asthma Trial In Community Settings
A Phase 3 study testing Azithromycin in people with Asthma, run by University of Wisconsin, Madison at 5 sites in United States.
Trial summary
The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2006to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and older (and at least 50 kg/110 pounds)
- The lower weight limit was chosen to avoid exposure to greater than 12 mg/kg/day of azithromycin (a currently recommended dose for children)
- We specify no upper age limit because asthma occurs throughout the age range and because asthma in the elderly is particularly severe and warrants inclusion.
- Physician-diagnosed asthma
- At the time of randomization, eligible subjects must either:
- be having a documented asthma exacerbation OR
Show all 11Show fewer
- be reporting at least mild persistent asthma symptoms, as defined by GINA (Global Initiative for Asthma)
- Subjects must also have asthma symptoms for at least six months prior to randomization
- Documentation of objective evidence of reversible airway obstruction, either spontaneously or after treatment, is required prior to randomization. This requirement can be met by documentary evidence, within 2 years of randomization, of either:
- a 12% or greater (and ≥200 mL) change in FEV1 OR
- a 25% or greater (and >60 L/min) change in PEFR either spontaneously or as a result of treatment
Who cannot join
- Not English literate or without email and internet access
- Macrolide allergy
- Pregnancy or lactation
- Females of childbearing potential must agree to use an acceptable form of contraception during the treatment period
- Chronic use of macrolides, tetracyclines or quinolones Chronic use is defined as 4 or more weeks of continuous use within 6 months of randomization
- Asthma symptoms for less than 6 months prior to randomization Asthma symptoms must be present for at least 6 months to exclude patients without true chronic asthma
Show all 20Show fewer
- Unstable asthma requiring immediate emergency care All patients with asthma exacerbations will receive usual urgent or emergency care for asthma and must be improving or stable in the judgment of the treating physician prior to being enrolled
- Specified co-morbidities likely to interfere with study assessments or follow up. Excluded comorbidities include:
- cystic fibrosis
- obstructive sleep apnea requiring CPAP
- cardiomyopathy
- congestive heart failure
- terminal cancer
- alcohol or other drug abuse
- or any other serious medical condition that, in the opinion of the study physician, would seriously interfere with or preclude assessment of study outcomes or completion of study assessments
- Specified medical conditions for which macrolide administration may possibly be hazardous
- Patients with acute or chronic hepatitis, cirrhosis or other liver disease, chronic kidney disease, or history of prolonged cardiac repolarization and QT interval or torsades de pointes, are excluded
- Specified medications for which close monitoring has been recommended in the setting of macrolide administration Patients taking digoxin, theophylline, warfarin, ergotamine or dihydroergotamine, triazolam, carbamazepine, cyclosporine, hexobarbital or phenytoin are excluded.
- If any of these medications are started after randomization and before completion of the 12-week treatment phase, study medication will be discontinued and the patient may remain in the study.
- The intent of this protocol is to enroll a broadly generalizable sample of adult patients with physician-diagnosed asthma, either stable persistent or in exacerbation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
RAP - Cleveland Clinic
Cleveland, Ohio, 44130
AAFP National Research Network
Kansas City, Kansas, 66211
Wisconsin Research and Education Network (WREN)
Madison, Wisconsin, 53713
University of Oklahoma Health Sciences Center (OUHSC) and Oklahoma Physicians Resource/Research Network (OKPRN)
Oklahoma City, Oklahoma, 73104
ANSR
Peoria, Illinois, 61602
About this study
Official title: AZMATICS: Azithromycin Asthma Trial In Community Settings
The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma.
Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma?
Read more
Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers.
Active study sites -
- Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison,
- Mauston, Rice Lake, Tomah, Wausau
- Colorado: Monument
- Illinois: Peoria
- Nevada: Reno
- North Carolina: Granite Falls
- North Dakota: Minot
- Ohio: Cleveland, Berea
- Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford
- Rhode Island: East Providence
Read the detailed description
1.0 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo, or join an observational open-label azithromycin cohort. Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile. Azithromycin or placebo will be adjunctive therapy for usual asthma care. The following patient-reported data will be collected via Zoomerang™ (a commercially-available data collection tool) periodically until one year after randomization: (1) study medication adherence and side effects weekly until 12 weeks, (2) asthma control and exacerbations every 6 weeks until 12 months, and (3) asthma quality of life and asthma controller medication changes every 3 months until 12 months. The primary hypothesis is that azithromycin will significantly improve asthma control (decrease symptoms and medication use) by 3 months (end treatment) and the improvement will continue to 12 months (end study). The primary outcome variable is overall asthma symptoms. Secondary outcomes are asthma medication use, quality of life and exacerbations. We will examine the predictive value of baseline patient characteristics including age, sex, smoking, co-morbid respiratory diagnoses and degree of airflow limitation. We will also examine for any imbalances between study groups in controller medication use, other antibiotic prescriptions and acute respiratory illnesses during the one-year study period.
We will enroll subjects from the practices of Wisconsin Research and Education Network (WREN) members, UW Department of Family Medicine physicians, Dean Medical Center primary care physicians, and from other practice-based research networks (PBRNs), medical group practices and individual primary care practices throughout North America.
Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service (office, urgent care, emergency room or hospital), by administrative data base review, or by physician recall. Most subjects will be the patients of study physicians. Other physicians in the group practice may refer subjects. Subjects also may be self-referred after responding to posters placed in the clinics. Some sites may elect to identify cases by medical record or database review, in which case only the personal physician may initiate patient contacts.
Treatment is azithromycin tablets, 600 milligrams orally once daily for 3 days, then 600 milligrams once weekly for an additional 11 weeks (total dose 8400 milligrams) or identical placebo, in addition to usual care for asthma.
- Conditions
- Asthma
- Being tested
- Azithromycin, Placebo
- Keywords
- Randomized clinical trial, Asthma, Adults, Azithromycin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
600 mg x 3 days, then 600 mg weekly x 11 weeks
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | Active adjunctive treatment Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Adjunctive placebo Receives: Drug: Placebo |
| Observational Cohort | Other | Eligible participants who declined randomization, offered enrollment in parallel, open-label azithromycin treatment arm Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overall Asthma Symptoms From Baseline
5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms
Measured: Within the past 24 hours; measured every 1.5 months for one year
Secondary outcomes (3)
Change in Asthma Control Over Baseline
Mini-Juniper Asthma Control Questionnaire without pulmonary function. This is a 6-item survey scored on a 7 point scale where 0 is none, or no symptoms and 6 is severe or symptoms all of the time. Answers are averaged for a final score of 0-6. Data are reported as a change from baseline.
Measured: Within the past week; every 3 months
Change is Asthma-specific Quality-of-Life (AQL)
Juniper Asthma Quality of Life Questionnaire is a 32-item survey, recall of the past 2 weeks, scored on a 7 point Likert scale where 1 is severely impaired, and 7 is not impaired at all. Scores are averaged for a final range of 1-7. Change from Baseline is reported here.
Measured: Within the past 2 weeks; every three months
Asthma Exacerbations
A steroid burst, an unscheduled or emergency visit and/or a hospitalization for asthma, reported at Weeks 0, 6, 12, 18, 24, 30, 36, 42, 48, and any time during follow up.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionNov 2010
- Study completionNov 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 (5)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms are randomized, placebo-controlled, double-blinded, 1 arm was added as an open-label observational cohort
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Family Physicians, Dean Foundation, Pfizer
- Responsible party
- Sponsor
- Investigators
- David L Hahn, MD, MS, Principal investigator, Wisconsin Research and Education Network (WREN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266851
- Sponsor's protocol ID
- H-2005-0258
- Status last verified
- Jul 2019
- First submitted
- 15 Dec 2005
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahn DL, Plane MB. Feasibility of a practical clinical trial for asthma conducted in primary care. J Am Board Fam Pract. 2004 May-Jun;17(3):190-5. doi: 10.3122/jabfm.17.3.190.
PubMed 15226283Hahn DL. Treatment of Chlamydia pneumoniae infection in adult asthma: a before-after trial. J Fam Pract. 1995 Oct;41(4):345-51.
PubMed 7561707Hahn DL. Chlamydia pneumoniae, asthma, and COPD: what is the evidence? Ann Allergy Asthma Immunol. 1999 Oct;83(4):271-88, 291; quiz 291-2. doi: 10.1016/S1081-1206(10)62666-X.
PubMed 10541419Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma. PLoS Clin Trials. 2006 Jun;1(2):e11. doi: 10.1371/journal.pctr.0010011. Epub 2006 Jun 30.
PubMed 16871333Hahn DL, Grasmick M, Hetzel S, Yale S; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012 Jul-Aug;25(4):442-59. doi: 10.3122/jabfm.2012.04.110309.
PubMed 22773713
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AZMATICS: Azithromycin Asthma Trial In Community Settings
- ClinicalTrials.gov ID
- NCT00266851
- Acronym / sponsor ID
- H-2005-0258
- Conditions
- Asthma
- Keywords
- Randomized clinical trial, Asthma, Adults, Azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- American Academy of Family Physicians, Dean Foundation, Pfizer
- Study start
- Jan 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma.
Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma?
Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers.
Active study sites -
- Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison,
- Mauston, Rice Lake, Tomah, Wausau
- Colorado: Monument
- Illinois: Peoria
- Nevada: Reno
- North Carolina: Granite Falls
- North Dakota: Minot
- Ohio: Cleveland, Berea
- Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford
- Rhode Island: East Providence
Detailed description
1.0 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo, or join an observational open-label azithromycin cohort. Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile. Azithromycin or placebo will be adjunctive therapy for usual asthma care. The following patient-reported data will be collected via Zoomerang™ (a commercially-available data collection tool) periodically until one year after randomization: (1) study medication adherence and side effects weekly until 12 weeks, (2) asthma control and exacerbations every 6 weeks until 12 months, and (3) asthma quality of life and asthma controller medication changes every 3 months until 12 months. The primary hypothesis is that azithromycin will significantly improve asthma control (decrease symptoms and medication use) by 3 months (end treatment) and the improvement will continue to 12 months (end study). The primary outcome variable is overall asthma symptoms. Secondary outcomes are asthma medication use, quality of life and exacerbations. We will examine the predictive value of baseline patient characteristics including age, sex, smoking, co-morbid respiratory diagnoses and degree of airflow limitation. We will also examine for any imbalances between study groups in controller medication use, other antibiotic prescriptions and acute respiratory illnesses during the one-year study period.
We will enroll subjects from the practices of Wisconsin Research and Education Network (WREN) members, UW Department of Family Medicine physicians, Dean Medical Center primary care physicians, and from other practice-based research networks (PBRNs), medical group practices and individual primary care practices throughout North America.
Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service (office, urgent care, emergency room or hospital), by administrative data base review, or by physician recall. Most subjects will be the patients of study physicians. Other physicians in the group practice may refer subjects. Subjects also may be self-referred after responding to posters placed in the clinics. Some sites may elect to identify cases by medical record or database review, in which case only the personal physician may initiate patient contacts.
Treatment is azithromycin tablets, 600 milligrams orally once daily for 3 days, then 600 milligrams once weekly for an additional 11 weeks (total dose 8400 milligrams) or identical placebo, in addition to usual care for asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 2 arms are randomized, placebo-controlled, double-blinded, 1 arm was added as an open-label observational cohort
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: AzithromycinActive adjunctive treatment |
| Placebo | Placebo comparator | Drug: PlaceboAdjunctive placebo |
| Observational Cohort | Other | Drug: AzithromycinEligible participants who declined randomization, offered enrollment in parallel, open-label azithromycin treatment arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 and older (and at least 50 kg/110 pounds)
- Physician-diagnosed asthma
- At the time of randomization, eligible subjects must either:
- Subjects must also have asthma symptoms for at least six months prior to randomization
- Documentation of objective evidence of reversible airway obstruction, either spontaneously or after treatment, is required prior to randomization. This requirement can be met by documentary evidence, within 2 years of randomization, of either:
Key exclusion criteria (20 listed)
- Not English literate or without email and internet access
- Macrolide allergy
- Pregnancy or lactation
- Females of childbearing potential must agree to use an acceptable form of contraception during the treatment period
- Chronic use of macrolides, tetracyclines or quinolones Chronic use is defined as 4 or more weeks of continuous use within 6 months of randomization
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 |
|---|---|---|
| AzithromycinAlso: Zithromax600 mg x 3 days, then 600 mg weekly x 11 weeks | Drug | Azithromycin, Observational Cohort |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Change in Overall Asthma Symptoms From Baseline
Time frame: Within the past 24 hours; measured every 1.5 months for one year
5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms
3 secondary outcomes
Change in Asthma Control Over Baseline
Time frame: Within the past week; every 3 months
Change is Asthma-specific Quality-of-Life (AQL)
Time frame: Within the past 2 weeks; every three months
Asthma Exacerbations
Time frame: up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15226283Hahn DL, Plane MB. Feasibility of a practical clinical trial for asthma conducted in primary care. J Am Board Fam Pract. 2004 May-Jun;17(3):190-5. doi: 10.3122/jabfm.17.3.190.
- Background: PubMed 7561707Hahn DL. Treatment of Chlamydia pneumoniae infection in adult asthma: a before-after trial. J Fam Pract. 1995 Oct;41(4):345-51.
- Background: PubMed 10541419Hahn DL. Chlamydia pneumoniae, asthma, and COPD: what is the evidence? Ann Allergy Asthma Immunol. 1999 Oct;83(4):271-88, 291; quiz 291-2. doi: 10.1016/S1081-1206(10)62666-X.
- Background: PubMed 16871333Hahn DL, Plane MB, Mahdi OS, Byrne GI. Secondary outcomes of a pilot randomized trial of azithromycin treatment for asthma. PLoS Clin Trials. 2006 Jun;1(2):e11. doi: 10.1371/journal.pctr.0010011. Epub 2006 Jun 30.
- Results publication: PubMed 22773713Hahn DL, Grasmick M, Hetzel S, Yale S; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012 Jul-Aug;25(4):442-59. doi: 10.3122/jabfm.2012.04.110309.
- Patient perspective/literature reviewLink provided by the sponsor.
- Book that reviews the topic of infection as a treatable cause for asthmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
David L Hahn, MD, MS principal investigator
Wisconsin Research and Education Network (WREN)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin in people with Asthma, run by University of Wisconsin, Madison at 5 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 11 inclusion and 20 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 6 Sep 2019). 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?
Change in Overall Asthma Symptoms From Baseline (time frame: Within the past 24 hours; measured every 1.5 months for one year). 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 NCT00266851, which also lists 5 linked publications.
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 6 Sep 2019.