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AsthmaPhase 3NCT02031640

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma

A Phase 3 study testing Beclomethasone dipropionate and Albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 131 sites in 4 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 is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Beclomethasone dipropionate and Albuterol/salbutamol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,113 participants
Where
131 sitesin 4 countries
Study dates
Dec 2013to Dec 2014
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference values at screening visit.
  • Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
  • Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at the screening visit
  • If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
  • Other criteria apply, please contact the investigator for more information

Who cannot join

  • The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
  • The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
  • The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
  • The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).
  • The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
  • The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
  • Other criteria apply, please contact the investigator for more information

Trial locations and contacts

131 sites in 4 countries.

131 sites in 4 countries

United States94 sites

  • Teva Investigational Site 10858

    Albany, Georgia

  • Teva Investigational Site 10820

    Austin, Texas

  • Teva Investigational Site 10826

    Aventura, Florida

  • Teva Investigational Site 10832

    Baltimore, Maryland

  • Teva Investigational Site 10794

    Bellevue, Nebraska

  • Teva Investigational Site 10814

    Bellevue, Nebraska

  • Teva Investigational Site 10805

    Bellingham, Washington

  • Teva Investigational Site 10850

    Bethesda, Maryland

  • Teva Investigational Site 10808

    Boerne, Texas

  • Teva Investigational Site 10846

    Brick, New Jersey

  • Teva Investigational Site 10842

    Canton, Ohio

  • Teva Investigational Site 12266

    Centennial, Colorado

  • Teva Investigational Site 10792

    Cincinnati, Ohio

  • Teva Investigational Site 10811

    Cincinnati, Ohio

  • Teva Investigational Site 10877

    Clearwater, Florida

  • Teva Investigational Site 10838

    Colorado Springs, Colorado

  • Teva Investigational Site 10869

    Columbia, Missouri

  • Teva Investigational Site 10851

    Costa Mesa, California

  • Teva Investigational Site 10830

    Dallas, Texas

  • Teva Investigational Site 10844

    Denver, Colorado

  • Teva Investigational Site 10816

    Edgewater, Florida

  • Teva Investigational Site 10831

    El Paso, Texas

  • Teva Investigational Site 10822

    Eugene, Oregon

  • Teva Investigational Site 10863

    Greenfield, Wisconsin

  • Teva Investigational Site 10849

    Huntington Beach, California

  • Teva Investigational Site 10872

    Huntington Beach, California

  • Teva Investigational Site 10809

    Indianapolis, Indiana

  • Teva Investigational Site 10795

    Iowa City, Iowa

  • Teva Investigational Site 10803

    Knoxville, Tennessee

  • Teva Investigational Site 10791

    Lake Oswego, Oregon

  • Teva Investigational Site 10862

    Lawrenceville, Georgia

  • Teva Investigational Site 10878

    Live Oak, Texas

  • Teva Investigational Site 10833

    Long Beach, California

  • Teva Investigational Site 10861

    Los Angeles, California

  • Teva Investigational Site 10836

    Madison, Wisconsin

  • Teva Investigational Site 10817

    Marlton, New Jersey

  • Teva Investigational Site 10824

    Medford, Oregon

  • Teva Investigational Site 12268

    Melbourne, Florida

  • Teva Investigational Site 10807

    Miami, Florida

  • Teva Investigational Site 10840

    Miami, Florida

  • Teva Investigational Site 12269

    Miami, Florida

  • Teva Investigational Site 10815

    Minneapolis, Minnesota

  • Teva Investigational Site 10821

    Minneapolis, Minnesota

  • Teva Investigational Site 10798

    Mission Viejo, California

  • Teva Investigational Site 12261

    Missoula, Montana

  • Teva Investigational Site 10837

    North Charleston, South Carolina

  • Teva Investigational Site 10834

    North Dartmouth, Massachusetts

  • Teva Investigational Site 10856

    Ocean City, New Jersey

  • Teva Investigational Site 10800

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10853

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10865

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12796

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10806

    Orange, California

  • Teva Investigational Site 10828

    Orange, California

  • Teva Investigational Site 12262

    Orangeburg, South Carolina

  • Teva Investigational Site 10870

    Owensboro, Kentucky

  • Teva Investigational Site 10860

    Paramount, California

  • Teva Investigational Site 10859

    Philadelphia, Pennsylvania

  • Teva Investigational Site 10810

    Plano, Texas

  • Teva Investigational Site 10835

    Portland, Oregon

  • Teva Investigational Site 10813

    Rancho Mirage, California

  • Teva Investigational Site 10796

    Richmond, Virginia

  • Teva Investigational Site 10854

    Richmond, Virginia

  • Teva Investigational Site 10829

    River Forest, Illinois

  • Teva Investigational Site 10843

    Riverside, California

  • Teva Investigational Site 10801

    Rochester, New York

  • Teva Investigational Site 10868

    Rolla, Missouri

  • Teva Investigational Site 10857

    Rolling Hills Estates, California

  • Teva Investigational Site 10797

    San Antonio, Texas

  • Teva Investigational Site 10812

    San Antonio, Texas

  • Teva Investigational Site 10847

    San Diego, California

  • Teva Investigational Site 10871

    San Diego, California

  • Teva Investigational Site 10876

    San Jose, California

  • Teva Investigational Site 10875

    Sarasota, Florida

  • Teva Investigational Site 10848

    Savannah, Georgia

  • Teva Investigational Site 10866

    Seattle, Washington

  • Teva Investigational Site 10845

    Skillman, New Jersey

  • Teva Investigational Site 10823

    South Burlington, Vermont

  • Teva Investigational Site 10867

    St Louis, Missouri

  • Teva Investigational Site 12271

    St Louis, Missouri

  • Teva Investigational Site 10793

    Sugar Land, Texas

  • Teva Investigational Site 10874

    Sylvania, Ohio

  • Teva Investigational Site 12264

    Tacoma, Washington

  • Teva Investigational Site 10855

    Tallahassee, Florida

  • Teva Investigational Site 10864

    Tampa, Florida

  • Teva Investigational Site 12265

    Toledo, Ohio

  • Teva Investigational Site 10818

    Tulsa, Oklahoma

  • Teva Investigational Site 10790

    Waco, Texas

  • Teva Investigational Site 12270

    Walnut Creek, California

  • Teva Investigational Site 10827

    Warrensburg, Missouri

  • Teva Investigational Site 12795

    Warwick, Rhode Island

  • Teva Investigational Site 10799

    Wheat Ridge, Colorado

  • Teva Investigational Site 10873

    Wheaton, Maryland

  • Teva Investigational Site 12272

    White Marsh, Maryland

Other trials in United States

Poland16 sites

  • Teva Investigational Site 53121

    Bialystok

  • Teva Investigational Site 53129

    Bialystok

  • Teva Investigational Site 53130

    Bialystok

  • Teva Investigational Site 53154

    Gdansk

  • Teva Investigational Site 53155

    Katowice

  • Teva Investigational Site 53124

    Krakow

  • Teva Investigational Site 53125

    Lodz

  • Teva Investigational Site 53132

    Lodz

  • Teva Investigational Site 53126

    Lubin

  • Teva Investigational Site 53157

    Lublin

  • Teva Investigational Site 53122

    Ostrów Wielkopolski

  • Teva Investigational Site 53156

    Poznan

  • Teva Investigational Site 53123

    Strzelce Opolskie

  • Teva Investigational Site 53127

    Tarnów

  • Teva Investigational Site 53131

    Warsaw

  • Teva Investigational Site 53128

    Wroclaw

Other trials in Poland

Germany11 sites

  • Teva Investigational Site 32326

    Berlin

  • Teva Investigational Site 32332

    Berlin

  • Teva Investigational Site 32334

    Berlin

  • Teva Investigational Site 32331

    Frankfurt

  • Teva Investigational Site 32335

    Gelnhausen

  • Teva Investigational Site 32329

    Leipzig

  • Teva Investigational Site 32330

    Magdeburg

  • Teva Investigational Site 32333

    Mainz

  • Teva Investigational Site 32328

    München

  • Teva Investigational Site 32327

    Munich

  • Teva Investigational Site 32325

    Rüdersdorf

Other trials in Germany

Hungary10 sites

  • Teva Investigational Site 51081

    Budapest

  • Teva Investigational Site 51083

    Debrecen

  • Teva Investigational Site 51084

    Debrecen

  • Teva Investigational Site 51080

    Érd

  • Teva Investigational Site 51108

    Győr

  • Teva Investigational Site 51079

    Kapuvár

  • Teva Investigational Site 51109

    Komárom

  • Teva Investigational Site 51086

    Nyíregyháza

  • Teva Investigational Site 51078

    Siófok

  • Teva Investigational Site 51087

    Szombathely

Other trials in Hungary

About this study

Official title: A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Conditions
Asthma
Being tested
Beclomethasone dipropionate, Placebo, Albuterol/salbutamol
Keywords
asthma, breath-actuated inhaler, metered-dose inhaler
Medical subject headings
Asthma

What participants receive

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

  • Beclomethasone dipropionateDrug

    Also called BDP

  • PlaceboDrug

  • Albuterol/salbutamolDrug

    Also called bronchodilators

    Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.

Study groups in NCT02031640
Study groupRoleWhat they receive
BDP 320 mcg BAIExperimentalBeclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Receives: Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol
BDP 640 mcg BAIExperimentalBeclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.
Receives: Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol
BDP 320 mcg MDIActive comparatorBeclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Receives: Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol
BDP 640 mcg MDIActive comparatorBeclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.
Receives: Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol
Placebo BAI and MDIPlacebo comparatorPlacebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.
Receives: Drug: Placebo; Drug: Albuterol/salbutamol

What is being measured

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

  1. Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )

    Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used.

    Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule.

    The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t <12 weeks (2, 4, or 8 weeks).

    Measured: Day 1 (baseline), Weeks 2, 4, 8, 12

Secondary outcomes (6)

  1. Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)

    A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.

    Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization.

    Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction.

    Measured: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12

  2. Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)

    A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.

    Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.

    Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction.

    Measured: Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12

  3. Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)

    Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit.

    Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction.

    Measured: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

  4. Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)

    Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments.

    Measured: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

  5. Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma

    Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are:

    • FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV.
    • Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period:
    • 4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma;
    • 3+ days in which 12+ inhalations/day of rescue medication were used
    • 2+ days in which the patient experienced a nighttime asthma symptom score of more than 2
    • Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization.

    Measured: Day 1 - Week 12

  6. Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

    A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.

    An example of alert criteria is:

    • FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).
    • Other criteria as defined in the protocol.

    Measured: Treatment period: Day 1 up to Week 12

Timeline

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

  1. First posted9 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2014
  4. Study completionDec 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031640
Sponsor's protocol ID
BDB-AS-301
Other IDs
2013-003397-27
Status last verified
Nov 2021
First submitted
7 Jan 2014
Last updated
9 Nov 2021
Data monitoring committee
No

Publications

  • Amar NJ, Moss MH, Kerwin EM, Li J, Small CJ. Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma. Allergy Asthma Proc. 2016 Sep;37(5):359-69. doi: 10.2500/aap.2016.37.3983. Epub 2016 Aug 9.

    PubMed 27510595

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone dipropionate and Albuterol/salbutamol in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 131 sites in 4 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 5 inclusion and 7 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Poland, Germany, Hungary. 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 5 Jan 2018). 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?

Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) ) (time frame: Day 1 (baseline), Weeks 2, 4, 8, 12). 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 NCT02031640, 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 9 Nov 2021.

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