A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma

Last updated: February 12, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

3

Condition

Asthma

Treatment

Placebo MDI HFA

BDA MDI HFO 160/180 μg

BDA MDI HFA 160/180 μg

Clinical Study ID

NCT06502366
D6933C00002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must be ≥ 18 years of age at the time of signing the ICF.

  • Participants who have physician diagnosed asthma as defined by GINA for at least 12months prior to Visit 1.

  • Eligible participants are on either a) no daily inhaled maintenance therapy or b)daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA.Participants who are on low-dose ICS maintenance therapy are required to be stableon therapy for a minimum of 3 months prior to Visit 1; participants using low-doseICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6months prior to Visit 1.

  • Participants with a pre-bronchodilator FEV1 of ≥ 60% and < 90% predicted normal atVisit 1 or Visit 1a.

  • Participants with a pre-dose FEV1 of ≥ 60% and < 90% predicted normal at Visit 2that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.

  • Participants who demonstrate bronchodilator responsiveness defined as a > 12% and > 200 mL increase in FEV1 relative to baseline following administration of studyprovided SABA at Visit 1 or Visit 1a.

  • Participants able to demonstrate acceptable spirometry performance as defined by theacceptability and repeatability criteria in the ATS/ERS Standardization ofSpirometry 2019 update

  • Participants who are willing and, in the opinion of the investigator, able to adjustcurrent asthma therapy, as required by the protocol.

  • Participants with a body mass index < 40 kg/m2.

  • Females must not be of childbearing potential or, if of childbearing potential,using a form of birth control

Exclusion

Exclusion Criteria:

  • Confirmed or suspected diagnosis of COPD or clinically significant non-asthmaairway/lung disease.

  • Systemic corticosteroid use (eg, prednisone for 3 or more days or a singledepo-injectable dose of corticosteroids) for any respiratory, immune, orallergy-attributed disease within 6 months prior to Visit 1.

  • An upper respiratory infection requiring antibiotic treatment that is not resolvedwithin 7 days prior to Visit 1.

  • A lower respiratory infection in the 4 weeks prior to Visit 1.

  • Life-threatening asthma defined as any history of significant asthma episode(s)requiring admission to an intensive care unit, positive pressure ventilationassociated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-relatedsyncopal episode(s) within 5 years of Visit 1.

  • Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg,prednisone for 3 or more days or a single depo-injectable dose of corticosteroids)for asthma within 6 months prior to Visit 1.

  • A severe asthma exacerbation during the run-in period

  • An ePRO device alert during the run-in period with investigator-confirmed worseningasthma symptoms

  • Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm,clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal,hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus,uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), orgastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal refluxdisease) disorders. Significant is defined as any disease that, in the opinion ofthe investigator, would put the safety of the participant at risk through studyparticipation or that could affect the efficacy or safety analyses if thedisease/condition exacerbated during the study.

  • Unresectable cancer that has not been in complete remission for at least 5 yearsprior to Visit 1

  • Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit

  • Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse atany time during the study.

Study Design

Total Participants: 422
Treatment Group(s): 3
Primary Treatment: Placebo MDI HFA
Phase: 3
Study Start date:
July 22, 2024
Estimated Completion Date:
March 03, 2026

Study Description

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

The study duration for each participant will be approximately 14 to 15 weeks and will consist of:

  1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention

  2. 3 treatment periods of 4 weeks each

  3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention

Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).

Connect with a study center

  • Research Site

    Anhui, 230061
    China

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    Baotou, 014010
    China

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    Baotou 2038432, 014010
    China

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    Changsha, 410015
    China

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    Changsha 1815577, 410015
    China

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    Chengdu, 610072
    China

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    Chengdu 1815286, 610072
    China

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    Chizhou, 247099
    China

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    Chizhou 1814934, 247099
    China

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    Chongqing, 401320
    China

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    Chongqing 1814906, 401320
    China

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    Guangzhou, 510163
    China

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    Guangzhou 1809858, 510150
    China

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  • Research Site

    Haikou, 570208
    China

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    Haikou 1809078, 570208
    China

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    Hangzhou, 310005
    China

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    Hangzhou 1808926, 310005
    China

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    Hefei, 230061
    China

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    Hefei 1808722, 230061
    China

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    Hohhot, 010017
    China

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    Hohhot 2036892, 010017
    China

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    Huizhou, 516001
    China

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    Huizhou 1806776, 516001
    China

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    Jinan, 250001
    China

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    Jinan 1805753, 250001
    China

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    Jinhua,
    China

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    Jinhua 1805528,
    China

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    Lanzhou, 730000
    China

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    Lanzhou 1804430, 730000
    China

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    Linhai, 317000
    China

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    Linhai 9906214, 317000
    China

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    Nanchang, 330006
    China

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    Nanchang 1800163, 330006
    China

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    Pingxiang, 337055
    China

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    Pingxiang 1798654, 337055
    China

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    Qingdao, 266011
    China

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    Qingdao 1797929, 266011
    China

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    Shanghai, 200080
    China

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    Shanghai 1796236, 310000
    China

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    Shenyang, 110004
    China

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    Shenyang 2034937, 110004
    China

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    Shenzhen, 518020
    China

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    Shenzhen 1795565, 518020
    China

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    Shijiazhuang, 50051
    China

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    Shijiazhuang 1795270, 50051
    China

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    Taiyuan, 030032
    China

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    Taiyuan 1793511, 030032
    China

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    Wenzhou, 325027
    China

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    Wenzhou 1791388, 325027
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    Wuhan, 430030
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    Wuhan 1791247, 430030
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    Xi'an, 710006
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    Xi'an 1790630, 710006
    China

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    Xuzhou, 221000
    China

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    Xuzhou 10630003, 221009
    China

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    Yangzhou, 225003
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    Yangzhou 1787227, 225003
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    Yinchuan, 750001
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    Yinchuan 1786657, 750001
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    Zhejiang, 311800
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    Zhengzhou, 450003
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    Zhengzhou 1784658, 450003
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    Zhuji, 311899
    China

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    Zhuji 1783940, 311899
    China

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    Alor Setar, 05400
    Malaysia

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    Alor Star 1736309, 05400
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    Ampang, 68000
    Malaysia

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    Ampang 1735168, 68000
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    Cheras, 56000
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    Cheras 1777077, 56000
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    Petaling Jaya, 47500
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    Petaling Jaya 1735158, 47500
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    Rawang, 48050
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    Rawang 1735150, 48050
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    Sandakan, 90000
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    Sandakan 1734052, 90000
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    Chihuahua, 31200
    Mexico

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    Chihuahua City 4014338, 31200
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    Cuernavaca, 62290
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    Cuernavaca 3529947, 62290
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    Culiacan, 80100
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    Culiacán 4012176, 80100
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    Durango, 34000
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    Durango 4011743, 34000
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    Guadalajara, 44130
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    Guadalajara 4005539, 44200
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    Mazatlán, 82000
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    Mazatlán 3996322, 82000
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    Mexico City, 3103
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    Mexico City 3530597, 3103
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    Monterrey, 64060
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    Monterrey 3995465, 64060
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    Mérida, 97070
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    Mérida 3523349, 97070
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    San Juan del Rio, 76800
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    San Juan del Río 3518692, 76800
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    Tijuana, 22010
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    Tijuana 3981609, 22010
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    Veracruz, 91900
    Mexico

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    Veracruz 3514783, 91900
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    Zapopan, 45138
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    Zapopan 3979770, 45138
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    Bangkoknoi, 10700
    Thailand

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    Khon Kaen, 40002
    Thailand

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    Khon Kaen 1609776, 40002
    Thailand

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    Mueang, 50200
    Thailand

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    Ratchathewi, 10400
    Thailand

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    Ratchathewi 7026885, 10400
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    Abu Dhabi,
    United Arab Emirates

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    Abu Dhabi 292968,
    United Arab Emirates

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    Ashton-under-Lyne, OL6 6EW
    United Kingdom

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    Ashton-under-Lyne 2656915, OL6 6EW
    United Kingdom

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    Glasgow, G20 7BE
    United Kingdom

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    Glasgow 2648579, G20 7BE
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    Newcastle, NE6 1SG
    United Kingdom

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    Newcastle upon Tyne 2641673, NE6 1SG
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    Newcastle-Upon-Tyne, NE6 1SG
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    Mobile, Alabama 36608
    United States

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    Sheffield, Alabama 35660
    United States

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    Mobile 4076598, Alabama 4829764 36608
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    Sheffield 4089536, Alabama 4829764 35660
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    Phoenix, Arizona 85018
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    Phoenix 5308655, Arizona 5551752 85018
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    Little Rock, Arkansas 72205
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    Little Rock 4119403, Arkansas 4099753 72205
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    Banning, California 92220
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    Encinitas, California 92024
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    Fullerton, California 92835
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    Gardena, California 90247
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    Huntington Beach, California 92647
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    La Mesa, California 91942
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    Los Angeles, California 90048
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    Panorama City, California 91402
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    Sacramento, California 95821
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    San Bernardino, California 92408
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    San Diego, California 92123
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    San Jose, California 95117
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    Santa Ana, California 92704
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    Stockton, California 95207
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    Van Nuys, California 91405
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    Westminster, California 92683
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    Encinitas 5346646, California 5332921 92024
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    Fullerton 5351247, California 5332921 92835
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    Gardena 5351549, California 5332921 90247
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    Huntington Beach 5358705, California 5332921 92647
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    La Mesa 5363990, California 5332921 91942
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    Los Angeles 5368361, California 5332921 90048
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    Sacramento 5389489, California 5332921 95821
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    San Bernardino 5391710, California 5332921 92408
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    San Diego 5391811, California 5332921 92123
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    San Jose 5392171, California 5332921 95117
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    Santa Ana 5392900, California 5332921 92704
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    Stockton 5399020, California 5332921 95207
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    Van Nuys 5405693, California 5332921 91405
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    Westminster 5408406, California 5332921 92683
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    Englewood, Colorado 80110
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    Wheat Ridge, Colorado 80033
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    Englewood 5421250, Colorado 5417618 80110
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    Wheat Ridge 5443948, Colorado 5417618 80033
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    Washington, District of Columbia 20016
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    Washington D.C. 4140963, District of Columbia 4138106 20016
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    Boynton Beach, Florida 33435
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    Miami, Florida 33175
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    Tallahassee, Florida 32308
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    Tampa, Florida 33607
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    Boynton Beach 4148677, Florida 4155751 33435
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    Miami 4164138, Florida 4155751 33175
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    Tallahassee 4174715, Florida 4155751 32308
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    Tampa 4174757, Florida 4155751 33607
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    Atlanta, Georgia 30328
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    Rincon, Georgia 31326
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    Savannah, Georgia 31406
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    Atlanta 4180439, Georgia 4197000 30328
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    Rincon 4218882, Georgia 4197000 31326
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    Savannah 4221552, Georgia 4197000 31406
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    Boise, Idaho 83706
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    Meridian, Idaho 83646
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    Boise 5586437, Idaho 5596512 83706
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    Meridian 5600685, Idaho 5596512 83646
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    River Forest, Illinois 60305
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    River Forest 4907637, Illinois 4896861 60305
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    Evansville, Indiana 47715
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    Valparaiso, Indiana 46383
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    Evansville 4257227, Indiana 4921868 47715
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    Valparaiso 4927537, Indiana 4921868 46383
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    Sioux City, Iowa 51106
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    Sioux City 4876523, Iowa 4862182 51106
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    Lexington, Kentucky 40509
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    Louisville, Kentucky 40217
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    Louisville 4299276, Kentucky 6254925 40217
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    Lafayette, Louisiana 70508
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    Metairie, Louisiana 70006
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    New Orleans, Louisiana 70119
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    Lafayette 4330145, Louisiana 4331987 70508
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    New Orleans 4335045, Louisiana 4331987 70119
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    White Marsh, Maryland 21162
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    White Marsh 4373426, Maryland 4361885 21162
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    Flint, Michigan 48504
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    Flint 4992982, Michigan 5001836 48504
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    Columbia, Missouri 65203
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    Saint Louis, Missouri 63141
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    Columbia 4381982, Missouri 4398678 65203
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    St Louis 4407066, Missouri 4398678 63141
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    Bellevue, Nebraska 68123
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    Omaha, Nebraska 68134
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    Omaha 5074472, Nebraska 5073708 68134
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    Middletown, New York 10940
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    Monticello, New York 12701
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    New York, New York 10036
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    Watertown, New York 13601
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    Monticello 5127359, New York 5128638 12701
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    New York 5128581, New York 5128638 10036
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    Watertown 5143396, New York 5128638 13601
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    Charlotte, North Carolina 28273
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    Raleigh, North Carolina 27607
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    Charlotte 4460243, North Carolina 4482348 28273
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    Raleigh 4487042, North Carolina 4482348 27607
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    Cincinnati, Ohio 45236
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    Cincinnati 4508722, Ohio 5165418 45236
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    Oklahoma City, Oklahoma 73120
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    Tulsa, Oklahoma 74136
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    Oklahoma City 4544349, Oklahoma 4544379 73120
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    Tulsa 4553433, Oklahoma 4544379 74136
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    Medford, Oregon 97504
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    Portland, Oregon 97202
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    Medford 5740099, Oregon 5744337 97504
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    Portland 5746545, Oregon 5744337 97202
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    DuBois, Pennsylvania 15801
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    Pottstown, Pennsylvania 19464
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    Scottdale, Pennsylvania 15683
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    Pottstown 5207069, Pennsylvania 6254927 19464
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    Scottdale 5211279, Pennsylvania 6254927 15683
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    Charleston, South Carolina 29414
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    Greenville, South Carolina 29615
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    North Charleston, South Carolina 29420
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    Spartanburg, South Carolina 29303
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    Charleston 4574324, South Carolina 4597040 29414
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    Greenville 4580543, South Carolina 4597040 29615
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    North Charleston 4589387, South Carolina 4597040 29420
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    Site Not Available

  • Research Site

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Site Not Available

  • Research Site

    Boerne, Texas 78006
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Research Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Research Site

    El Paso, Texas 79924
    United States

    Site Not Available

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Research Site

    Pearland, Texas 77584
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Research Site

    Victoria, Texas 77901
    United States

    Site Not Available

  • Research Site

    Boerne 4675373, Texas 4736286 78006
    United States

    Site Not Available

  • Research Site

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Research Site

    DeSoto 4685524, Texas 4736286 75115
    United States

    Site Not Available

  • Research Site

    El Paso 5520993, Texas 4736286 79924
    United States

    Site Not Available

  • Research Site

    Kingwood 7534469, Texas 4736286 77339
    United States

    Site Not Available

  • Research Site

    McKinney 4710178, Texas 4736286 75069
    United States

    Site Not Available

  • Research Site

    Pearland 4718097, Texas 4736286 77584
    United States

    Site Not Available

  • Research Site

    San Antonio 4726206, Texas 4736286 78258
    United States

    Site Not Available

  • Research Site

    Victoria 4739157, Texas 4736286 77901
    United States

    Site Not Available

  • Research Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Research Site

    West Jordan 5784549, Utah 5549030 84088
    United States

    Site Not Available

  • Research Site

    Burke, Virginia 22015
    United States

    Site Not Available

  • Research Site

    Portsmouth, Virginia 23703
    United States

    Site Not Available

  • Research Site

    Burke 4749950, Virginia 6254928 22015
    United States

    Site Not Available

  • Research Site

    Portsmouth 4779999, Virginia 6254928 23703
    United States

    Site Not Available

  • Research Site

    Spokane, Washington 99218
    United States

    Site Not Available

  • Research Site

    Spokane 5811696, Washington 5815135 99218
    United States

    Site Not Available

  • Research Site

    Morgantown, West Virginia 26505
    United States

    Site Not Available

  • Research Site

    Morgantown 4815352, West Virginia 4826850 26505
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53228
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53228
    United States

    Site Not Available

  • Research Site

    Can Tho, 900000
    Vietnam

    Site Not Available

  • Research Site

    Can Tho 1586203, 900000
    Vietnam

    Site Not Available

  • Research Site

    Hai Phong, 180000
    Vietnam

    Site Not Available

  • Research Site

    Haiphong 1581298, 180000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi, 100000
    Vietnam

    Site Not Available

  • Research Site

    Hanoi 1581130, 100000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City, 700000
    Vietnam

    Site Not Available

  • Research Site

    Ho Chi Minh City 1566083, 700000
    Vietnam

    Site Not Available

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