A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

Last updated: March 31, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Bronchiectasis

Emphysema

Chronic Bronchitis

Treatment

Tezepelumab

Placebo

Clinical Study ID

NCT06878261
D5241C00007
  • Ages 40-80
  • All Genders

Study Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥40 to ≤80 years old

  2. COPD diagnosis ≥1 year,

  3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening

  4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior toV1

  5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2moderate exacerbations must require the use of systemic corticosteroids

  6. EOS ≥ 150 cells/μL during screening

  7. CAT ≥15 at screening

  8. Former or current smokers ≥10 pack-years

Exclusion

Exclusion Criteria:

  1. Clin. important pulmonary disease or radiological findings suggestive of arespiratory disease other than COPD

  2. Asthma, incl. pediatric, or ACOS

  3. Any unstable disorder that can impact participants safety or study outcomes

  4. Tuberculosis requiring treatment within 12 months prior V2

  5. Malignancies current or past Concomitant therapies:

  • Macrolides (less than 6 months)

  • Systemic immuno-suppressive, -modulating medications

  1. LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Study Design

Total Participants: 990
Treatment Group(s): 2
Primary Treatment: Tezepelumab
Phase: 3
Study Start date:
March 25, 2025
Estimated Completion Date:
June 05, 2029

Study Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Connect with a study center

  • Research Site

    Frankston, 3199
    Australia

    Site Not Available

  • Research Site

    Garran, 2605
    Australia

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  • Research Site

    Spearwood, 6163
    Australia

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  • Research Site

    Woodville South, 5011
    Australia

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  • Research Site

    Genk, 3600
    Belgium

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  • Research Site

    Gent, 9000
    Belgium

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  • Research Site

    Jette, 1090
    Belgium

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  • Research Site

    Leuven, 3000
    Belgium

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  • Research Site

    Mechelen, 2800
    Belgium

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  • Research Site

    Namur, 5101
    Belgium

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    Dupnitsa, 2600
    Bulgaria

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  • Research Site

    Lovech, 5500
    Bulgaria

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  • Research Site

    Pleven, 5804
    Bulgaria

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    Plovdiv, 4003
    Bulgaria

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  • Research Site

    Ruse, 7000
    Bulgaria

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    Sofia, 1756
    Bulgaria

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    Stara Zagora, 6003
    Bulgaria

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    Varna, 9000
    Bulgaria

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  • Research Site

    Veliko Tanovo, 5000
    Bulgaria

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    Veliko Tarnovo, 5000
    Bulgaria

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    Vidin, 3700
    Bulgaria

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    Yambol, 8600
    Bulgaria

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    Armenia, 630004
    Colombia

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    Barranquilla, 080020
    Colombia

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    Cali, 760042
    Colombia

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    Ibague, 730006
    Colombia

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    Manizales, 170004
    Colombia

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    Medellin, 050022
    Colombia

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    Medellín, 050030
    Colombia

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    Aalborg, 9000
    Denmark

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    Hvidovre, 2650
    Denmark

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    Næstved, 4700
    Denmark

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    Odense C, 5000
    Denmark

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    Vejle, 7100
    Denmark

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    Brest Cedex 2, 29609
    France

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    Lyon Cedex 04, 69317
    France

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    Marseille, 13915
    France

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    Montpellier Cedex 5, 34295
    France

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    Paris, 75014
    France

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    Paris Cedex 18, 75877
    France

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    Pessac, 33604
    France

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    Saint Herblain, 44800
    France

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    Athens, 11521
    Greece

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    Heraklion, 71110
    Greece

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    Ioannina, 45500
    Greece

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    Patra, 26332
    Greece

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    Thessaloniki, 57010
    Greece

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    Hong Kong,
    Hong Kong

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    Budapest, 1036
    Hungary

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    Debrecen, 4032
    Hungary

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    Edelény, 3780
    Hungary

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    Gödöllő, 2100
    Hungary

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    Hatvan, 3000
    Hungary

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    Mosonmagyaróvár, 9200
    Hungary

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    Nyíregyháza-Sóstóhegy, 4481
    Hungary

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    Törökbálint, 2045
    Hungary

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    Ashkelon, 78278
    Israel

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    Haifa, 34362
    Israel

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    Jerusalem, 00000
    Israel

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    Kfar Saba, 4428164
    Israel

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    Ramat Gan, 52621
    Israel

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    Rehovot, 76100
    Israel

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    Tel Aviv, 6423906
    Israel

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    Akashi-shi, 674-0063
    Japan

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    Fukui-shi, 910-8526
    Japan

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    Fukuoka-shi, 811-1394
    Japan

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    Ishinomaki, 986-8522
    Japan

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    Kasuga-shi, 816-0864
    Japan

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    Kiyose-shi, 204-8585
    Japan

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  • Research Site

    Kobe-shi, 650-0047
    Japan

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    Komatsu-shi, 923-8560
    Japan

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  • Research Site

    Kure-shi, 737-8505
    Japan

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  • Research Site

    Meguro-ku, 153-0051
    Japan

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    Minato-ku, 108-0073
    Japan

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    Miyazaki-shi, 889-1692
    Japan

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    Nagoya-shi, 457-8511
    Japan

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    Nerima-ku, 177-8521
    Japan

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    Ohta-ku, 143-0013
    Japan

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    Shinjuku-ku, 162-8655
    Japan

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    Shiogama City, 985-8506
    Japan

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    Takamatsu-shi, 760-0018
    Japan

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    Takatsuiki-shi, 569-1096
    Japan

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    Toshima-ku, 171-0014
    Japan

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    Ube, 755-8505
    Japan

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    Yokohama-shi, 236-0004
    Japan

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    Eindhoven, 5623 EJ
    Netherlands

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    Maastricht, 6229 HX
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    Rotterdam, 3083 AN
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    Zutphen, 7207 AE
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    Auckland, 1051
    New Zealand

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    Hamilton West, 3204
    New Zealand

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    Tauranga, 3112
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    Lima, LIMA 21
    Peru

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    Piura, 20001
    Peru

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    Benoni, 1501
    South Africa

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    Cape Town, 7700
    South Africa

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    Durban, 4093
    South Africa

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    Somerset West, 7130
    South Africa

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    Tygervalley, 7530
    South Africa

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  • Research Site

    Karlskrona, 371 79
    Sweden

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    Lund, 22185
    Sweden

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    Stockholm, 171 64
    Sweden

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    Örebro, 703 62
    Sweden

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  • Research Site

    Bang Kra So, 11000
    Thailand

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    Bangkok, 10330
    Thailand

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    Hat Yai, 90110
    Thailand

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    Hatyai, 90110
    Thailand

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    Muang, 40002
    Thailand

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    Mueang, 20000
    Thailand

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    Rayong, 21000
    Thailand

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  • Research Site

    Tempe, Arizona 85283
    United States

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  • Research Site

    Redding, California 96001
    United States

    Active - Recruiting

  • Research Site

    San Diego, California 92108
    United States

    Active - Recruiting

  • Research Site

    Boynton Beach, Florida 33435
    United States

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  • Research Site

    Clearwater, Florida 33765
    United States

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  • Research Site

    Jacksonville, Florida 32209
    United States

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  • Research Site

    Margate, Florida 33063
    United States

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  • Research Site

    Miami, Florida 33155
    United States

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    Miami Lakes, Florida 33014
    United States

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  • Research Site

    Ocala, Florida 34470
    United States

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    Palmetto Bay, Florida 33157
    United States

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    Adairsville, Georgia 30103
    United States

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  • Research Site

    Atlanta, Georgia 30349
    United States

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  • Research Site

    Fort Eisenhower, Georgia 30905
    United States

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  • Research Site

    Savannah, Georgia 31406
    United States

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  • Research Site

    Evansville, Indiana 47710
    United States

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  • Research Site

    Indianapolis, Indiana 46268
    United States

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  • Research Site

    Kansas City, Kansas 66160
    United States

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  • Research Site

    Bowling Green, Kentucky 42101
    United States

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    Owensboro, Kentucky 42301
    United States

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  • Research Site

    Baltimore, Maryland 21224
    United States

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  • Research Site

    Potomac, Maryland 20854
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    Minneapolis, Minnesota 55425
    United States

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    Hannibal, Missouri 63401
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    Charlotte, North Carolina 28277
    United States

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    Fayetteville, North Carolina 28303
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    Oklahoma City, Oklahoma 73102
    United States

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    Tulsa, Oklahoma 74133
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    Grants Pass, Oregon 97527
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    Anderson, South Carolina 29621
    United States

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    Columbia, South Carolina 29204
    United States

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    Gaffney, South Carolina 29340
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    Spartanburg, South Carolina 29303
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  • Research Site

    Union, South Carolina 29379
    United States

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    Rapid City, South Dakota 57702
    United States

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    Knoxville, Tennessee 37919
    United States

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    Boerne, Texas 78006
    United States

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    El Paso, Texas 79902
    United States

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    Houston, Texas 77008
    United States

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  • Research Site

    Lewisville, Texas 75067
    United States

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    McKinney, Texas 75069
    United States

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  • Research Site

    Colchester, Vermont 05446
    United States

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    Williamsburg, Virginia 23188
    United States

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  • Research Site

    Everett, Washington 98208
    United States

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  • Research Site

    Hanoi, 100000
    Vietnam

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  • Research Site

    Ho Chi Minh, 700000
    Vietnam

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