New inhaler shows promise for cutting asthma attacks in high-risk patients

NCT ID NCT06529419

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental inhaled drug called AZD8630 in 537 adults whose asthma is not well controlled despite using standard inhalers. Participants took the drug or a placebo once daily for 12 weeks. The goal was to see if the drug could reduce asthma flare-ups and improve lung function and symptom control.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

537 people

The number who actually took part.

Started

Aug 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Principal inclusion criteria (abbreviated): 1. Patient must be 18 to 80 years of age inclusive 2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years 4\. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5) 5\. Pre-BD FEV1 ≥ 40% 7\. A history of asthma exacerbations within the last 12 months 8\. \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry. 10\. BMI within the range 18-37 kg/m2 (inclusive) 11\. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception. 12\. Male patients and their female partners of childbearing potential must agree to use highly effective contraception. 13\. Capable of giving signed informed consent. Principal exclusion criteria (abbreviated): 1. History of life-threatening asthma 2. Recently completed treatment for respiratory infection and/or asthma exacerbation 3. Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease. 4. Any disorder that is not stable in the opinion of the Investigator and could: 1. Affect the safety of the patient throughout the study 2. Influence the findings of the study or their interpretation 3. Impede the patient's ability to complete the entire duration of study 5. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB. 6. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C 7. Patients with history of HIV infection or who test positive for HIV. 8. Congenital long QT syndrome or prolonged QTcF \> 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication. 9. Current untreated or uncontrolled arrhythmia. 10. Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting. 11. A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy. 12. Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months ago. 13. Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study. 14. Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years. 15. Any other clinically relevant abnormal findings that in the opinion of the Investigator or medical monitor might compromise the safety of the patient in the study or interfere with evaluation of the study intervention. 16. Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives. 17. Treatment with Systemic steroids within 4 weeks. 18. Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

Research Site

Mesa, Arizona, 85213, United States
Research Site

Huntington Beach, California, 92647, United States
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La Mesa, California, 91942, United States
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Laguna Niguel, California, 92677, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90815, United States
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San Jose, California, 95117, United States
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New Haven, Connecticut, 06510, United States
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DeBary, Florida, 32713, United States
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Jacksonville, Florida, 32216, United States
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Jensen Beach, Florida, 34957, United States
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Largo, Florida, 33777, United States
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Miami, Florida, 33135, United States
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Miami Lakes, Florida, 33014, United States
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Tampa, Florida, 33607, United States
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Lilburn, Georgia, 30047, United States
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Savannah, Georgia, 31406, United States
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Chicago, Illinois, 60616, United States
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Winfield, Illinois, 60190, United States
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Ames, Iowa, 50010, United States
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Kansas City, Kansas, 66160, United States
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Baltimore, Maryland, 21237, United States
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Methuen, Massachusetts, 01844, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48202, United States
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Las Vegas, Nevada, 89102, United States
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Las Vegas, Nevada, 89119, United States
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Riverdale, New Jersey, 07457, United States
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Middletown, New York, 10941, United States
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Greenville, North Carolina, 27834, United States
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Winston-Salem, North Carolina, 27104, United States
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Beavercreek, Ohio, 45431, United States
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Lima, Ohio, 45801, United States
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Oklahoma City, Oklahoma, 73120, United States
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Horsham, Pennsylvania, 19044, United States
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Austin, Texas, 78704, United States
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McKinney, Texas, 75069, United States
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Mesquite, Texas, 75149, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78215, United States
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American Fork, Utah, 84003, United States
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Roy, Utah, 84067, United States
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Salt Lake City, Utah, 84124, United States
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Hampton, Virginia, 23666, United States
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Milwaukee, Wisconsin, 53228, United States
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Alberdi, X5033DCE, Argentina
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CABA, C1426, Argentina
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Capital Federal, C1060ABN, Argentina
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Mar del Plata, 7600, Argentina
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Quilmes, B1878FNR, Argentina
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Rosario, 2000, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Duffel, 2570, Belgium
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Mechelen, 2800, Belgium
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Namur, 5101, Belgium
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Chile, 7770484, Chile
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Curicó, 3341643, Chile
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Santiago, 7500587, Chile
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Santiago, 7500691, Chile
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Talca, 3465584, Chile
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Viña del Mar, 2540488, Chile
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Baotou, 014010, China
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Changchun, 130021, China
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Chengdu, 610078, China
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Chongqing, 401320, China
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Guangzhou, 510163, China
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Guiyang, 510630, China
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Hefei, 230061, China
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Hohhot, 010010, China
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Jinan, 250021, China
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Lanzhou, 730000, China
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Nanchang, 330006, China
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Ningbo, 315010, China
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Qingdao, 266011, China
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Shanghai, 200080, China
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Shenyang, 110004, China
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Shijiazhuang, 050051, China
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Taiyuan, 030032, China
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Wenzhou, 325027, China
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Xuzhou, 221000, China
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Brno, 62500, Czechia
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Hradec Králové, 50005, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Kralupy nad Vltavou, 278 01, Czechia
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Pilsen, 32300, Czechia
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Prague, 15300, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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Aalborg, 9100, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Odense, 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Lyon, 69317, France
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Marseille, 13915, France
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Nice, F-06002, France
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Paris, 75018, France
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Reims, 51092, France
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Berlin, 10119, Germany
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Bonn, 53127, Germany
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Essen, 45239, Germany
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Frankfurt, 60596, Germany
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Landsberg, 86899, Germany
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Leipzig, 04207, Germany
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Mainz, 55128, Germany
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Marburg, 35037, Germany
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Hong Kong, Hong Kong
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Ashkelon, 78278, Israel
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Jerusalem, 9372212, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Genoa, 16132, Italy
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Milan, 20122, Italy
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Roma, 00168, Italy
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Roma, 161, Italy
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Chūōku, 104-0031, Japan
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Fukuoka, 819-8555, Japan
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Hiratsuka-shi, 254-8502, Japan
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Hiroshima, 730-0013, Japan
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Kitakyushu, 802-0052, Japan
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Kusatsu-shi, 525-8585, Japan
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Maebashi, 371-0048, Japan
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Maebashi, 371-0054, Japan
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Meguro-ku, 153-8515, Japan
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Mizunami-shi, 509-6134, Japan
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Nankoku-shi, 783-8509, Japan
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Niigata, 950-1197, Japan
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Sakaishi, 591-8555, Japan
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Sapporo, 064-0804, Japan
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Shinjuku-ku, 162-8655, Japan
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Toyoake-shi, 470-1192, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 236-0037, Japan
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Durango, 34200, Mexico
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Guadalajara, 44130, Mexico
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Monterrey, 64040, Mexico
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Monterrey, 64710, Mexico
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Villahermosa, 86035, Mexico
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Alkmaar, 1815 JD, Netherlands
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Amersfoort, 3813 TZ, Netherlands
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Kežmarok, 060 01, Slovakia
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Košice, 04022, Slovakia
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Levice, 93401, Slovakia
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Prešov, 081 81, Slovakia
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Topoľčany, 955 01, Slovakia
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Topoľčany, 95501, Slovakia
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Žilina, 010 01, Slovakia
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Cape Town, 7700, South Africa
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Durban, 4001, South Africa
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eMkhomazi, 4170, South Africa
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Observatory, 7925, South Africa
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Somerset West, 7130, South Africa
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Tygervalley, 7530, South Africa
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Daegu, 42415, South Korea
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Seoul, 03312, South Korea
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Seoul, 06591, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Barcelona, 8035, Spain
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Benalmádena, 29631, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Taichung, 433004, Taiwan
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Taipei, 0116, Taiwan
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Taipei, 100, Taiwan
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Taipei, 110, Taiwan
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Taoyuan, 333, Taiwan
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Adana, 1330, Turkey (Türkiye)
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Altındağ-Ankara, 06230, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, 34854, Turkey (Türkiye)
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Kirikkale, 71450, Turkey (Türkiye)
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Mersin, 33079, Turkey (Türkiye)
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Chernivtsі, 58002, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Ivano-Frankivsk, 76019, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 02081, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03680, Ukraine
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Lutsk, 43000, Ukraine
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Uzhhorod, 88018, Ukraine
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Vinnytsia, 21029, Ukraine
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Bradford, BD9 6RJ, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom

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