AsthmaPhase 2LevanteNCT06529419
A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations
A Phase 2 study testing AZD8630 and Inhaler in people with Asthma, run by AstraZeneca at 196 sites in 23 countries.
Trial summary
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD8630 and Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 537 participants
- Where
- 196 sitesin 23 countries
- Study dates
- 30 Aug 2024to 4 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Principal inclusion criteria (abbreviated):
- Patient must be 18 to 80 years of age inclusive
- 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
- Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)
- Pre-BD FEV1 ≥ 40%
- A history of asthma exacerbations within the last 12 months
- \& 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.
- BMI within the range 18-37 kg/m2 (inclusive)
- Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.
- Male patients and their female partners of childbearing potential must agree to use highly effective contraception.
- Capable of giving signed informed consent.
Principal exclusion criteria (abbreviated):
- History of life-threatening asthma
- Recently completed treatment for respiratory infection and/or asthma exacerbation
- Clinically important pulmonary disease other than asthma; including but not limited to those with co-existent chronic obstructive pulmonary disease.
- Any disorder that is not stable in the opinion of the Investigator and could:
- Affect the safety of the patient throughout the study
- Influence the findings of the study or their interpretation
- Impede the patient's ability to complete the entire duration of study
- Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.
- Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C
- Patients with history of HIV infection or who test positive for HIV.
- Congenital long QT syndrome or prolonged QTcF > 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
- Current untreated or uncontrolled arrhythmia.
- Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.
- A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.
- Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months ago.
- Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study.
- Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years.
- 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.
- Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives.
- Treatment with Systemic steroids within 4 weeks.
- Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).
Trial locations and contacts
196 sites in 23 countries.
196 sites in 23 countries
United States45 sites
Research Site
American Fork, Utah, 84003
Research Site
Ames, Iowa, 50010
Research Site
Ann Arbor, Michigan, 48109
Research Site
Austin, Texas, 78704
Research Site
Baltimore, Maryland, 21237
Research Site
Beavercreek, Ohio, 45431
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Chicago, Illinois, 60616
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DeBary, Florida, 32713
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Detroit, Michigan, 48202
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Greenville, North Carolina, 27834
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Hampton, Virginia, 23666
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Horsham, Pennsylvania, 19044
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Huntington Beach, California, 92647
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Jacksonville, Florida, 32216
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Jensen Beach, Florida, 34957
Research Site
Kansas City, Kansas, 66160
Research Site
La Mesa, California, 91942
Research Site
Laguna Niguel, California, 92677
Research Site
Lancaster, California, 93534
Research Site
Largo, Florida, 33777
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Las Vegas, Nevada, 89102
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Las Vegas, Nevada, 89119
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Lilburn, Georgia, 30047
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Lima, Ohio, 45801
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Long Beach, California, 90815
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McKinney, Texas, 75069
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Mesa, Arizona, 85213
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Mesquite, Texas, 75149
Research Site
Methuen, Massachusetts, 01844
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Miami, Florida, 33135
Research Site
Miami Lakes, Florida, 33014
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Middletown, New York, 10941
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Milwaukee, Wisconsin, 53228
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New Haven, Connecticut, 06510
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Oklahoma City, Oklahoma, 73120
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Pearland, Texas, 77584
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Riverdale, New Jersey, 07457
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Roy, Utah, 84067
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Salt Lake City, Utah, 84124
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San Antonio, Texas, 78215
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San Jose, California, 95117
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Savannah, Georgia, 31406
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Tampa, Florida, 33607
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Winfield, Illinois, 60190
Research Site
Winston-Salem, North Carolina, 27104
China19 sites
Research Site
Baotou, 014010
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Changchun, 130021
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Chengdu, 610078
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Chongqing, 401320
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Guangzhou, 510163
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Guiyang, 510630
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Hefei, 230061
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Hohhot, 010010
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Jinan, 250021
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Lanzhou, 730000
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Nanchang, 330006
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Ningbo, 315010
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Qingdao, 266011
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Shanghai, 200080
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Shenyang, 110004
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Shijiazhuang, 050051
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Taiyuan, 030032
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Wenzhou, 325027
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Xuzhou, 221000
Japan18 sites
Research Site
Chūōku, 104-0031
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Fukuoka, 819-8555
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Hiratsuka-shi, 254-8502
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Hiroshima, 730-0013
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Kitakyushu, 802-0052
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Kusatsu-shi, 525-8585
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Maebashi, 371-0048
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Maebashi, 371-0054
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Meguro-ku, 153-8515
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Mizunami-shi, 509-6134
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Nankoku-shi, 783-8509
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Niigata, 950-1197
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Sakaishi, 591-8555
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Sapporo, 064-0804
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Shinjuku-ku, 162-8655
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Toyoake-shi, 470-1192
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Yanagawa-shi, 832-0059
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Yokohama, 236-0037
Ukraine11 sites
Research Site
Chernivtsі, 58002
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Ivano-Frankivsk, 76018
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Ivano-Frankivsk, 76019
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Kyiv, 02002
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Kyiv, 02081
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Kyiv, 03037
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Kyiv, 03049
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Kyiv, 03680
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Lutsk, 43000
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Uzhhorod, 88018
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Vinnytsia, 21029
Argentina9 sites
Research Site
Alberdi, X5033DCE
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CABA, C1426
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Capital Federal, C1060ABN
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Mar del Plata, 7600
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Quilmes, B1878FNR
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Rosario, 2000
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San Fernando, B1646EBJ
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San Juan Bautista, 1888
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San Miguel de Tucumán, 4000
Czechia8 sites
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Brno, 62500
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Hradec Králové, 50005
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Jindřichův Hradec, 377 01
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Kralupy nad Vltavou, 278 01
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Pilsen, 32300
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Prague, 15300
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Teplice, 415 01
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Varnsdorf, 407 47
Germany8 sites
Research Site
Berlin, 10119
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Bonn, 53127
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Essen, 45239
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Frankfurt, 60596
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Landsberg, 86899
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Leipzig, 04207
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Mainz, 55128
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Marburg, 35037
Spain8 sites
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Barcelona, 8035
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Benalmádena, 29631
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Madrid, 28041
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Majadahonda, 28222
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Málaga, 29010
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Palma de Mallorca, 07010
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Santander, 39008
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Valencia, 46010
Slovakia7 sites
Research Site
Kežmarok, 060 01
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Košice, 04022
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Levice, 93401
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Prešov, 081 81
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Topoľčany, 955 01
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Topoľčany, 95501
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Žilina, 010 01
Taiwan7 sites
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Kaohsiung City, 80756
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Taichung, 40705
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Taichung, 433004
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Taipei, 0116
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Taipei, 100
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Taipei, 110
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Taoyuan, 333
Chile6 sites
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Chile, 7770484
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Curicó, 3341643
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Santiago, 7500587
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Santiago, 7500691
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Talca, 3465584
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Viña del Mar, 2540488
Denmark6 sites
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Aalborg, 9100
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Hvidovre, 2650
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København NV, 2400
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Odense, 5000
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Roskilde, 4000
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Vejle, 7100
South Africa6 sites
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Cape Town, 7700
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Durban, 4001
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eMkhomazi, 4170
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Observatory, 7925
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Somerset West, 7130
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Tygervalley, 7530
Turkey (Türkiye)6 sites
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Adana, 1330
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Altındağ-Ankara, 06230
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Ankara
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Istanbul, 34854
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Kirikkale, 71450
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Mersin, 33079
France5 sites
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Lyon, 69317
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Marseille, 13915
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Nice, F-06002
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Paris, 75018
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Reims, 51092
Mexico5 sites
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Durango, 34200
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Guadalajara, 44130
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Monterrey, 64040
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Monterrey, 64710
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Villahermosa, 86035
South Korea5 sites
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Daegu, 42415
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Seoul, 03312
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Seoul, 06591
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Seoul, 3722
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Seoul, 5505
Israel4 sites
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Ashkelon, 78278
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Jerusalem, 9372212
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Rehovot, 76100
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Tel Aviv, 6423906
Italy4 sites
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Genoa, 16132
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Milan, 20122
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Roma, 00168
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Roma, 161
Belgium3 sites
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Duffel, 2570
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Mechelen, 2800
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Namur, 5101
United Kingdom3 sites
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Bradford, BD9 6RJ
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Liverpool, L7 8XP
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Portsmouth, PO6 3LY
Netherlands2 sites
Research Site
Alkmaar, 1815 JD
Research Site
Amersfoort, 3813 TZ
About this study
Official title: A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).
Read the detailed description
This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks.
This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally
- Conditions
- Asthma
- Being tested
- AZD8630, Placebo, Inhaler
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8630Drug
The drug will be administered by inhalation
PlaceboDrug
The placebo will be administered by inhalation
InhalerDevice
The drug/placebo will be administered by inhalation using the inhaler
| Study group | Role | What they receive |
|---|---|---|
| AZD8630 dose A | Experimental | Inhaled AZD8630 administered at a dose A Receives: Drug: AZD8630; Device: Inhaler |
| AZD8630 dose B | Experimental | Inhaled AZD8630 administered at a dose B Receives: Drug: AZD8630; Device: Inhaler |
| AZD8630 dose C | Experimental | Inhaled AZD8630 administered at a dose C Receives: Drug: AZD8630; Device: Inhaler |
| Placebo | Placebo comparator | Inhaled placebo Receives: Drug: Placebo; Device: Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first CompEx Asthma event
The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables:
- PEF
- Asthma symptom score (0 to 3)
- Use of rescue medication
Measured: 12 weeks
Secondary outcomes (5)
Pre-BD FEV1
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second.
Measured: 12 weeks
ACQ-6:
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6). The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease
Measured: 12 weeks
AQLQ12+
Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains
Measured: 12 weeks
SGRQ
Change from baseline in the St. George's Respiratory Questionnaire. The SGRQ includes 50 questions grouped into two parts: Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall.
Measured: 12 weeks
FeNO
Change from baseline to: FeNO: Weeks 1, 2, 4, 8, and 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Aug 2024
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group treatment study with 4 arms that is patient and Investigator blinded. Patients will be randomly assigned in a 1:1:1:1 ratio to one of the 4 treatment arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 537 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Njira Lugogo, Principal investigator, Univeristy of Michigan Hospital, Ann Arbor, MI, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529419
- Sponsor's protocol ID
- D6830C00003
- Acronym
- Levante
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomised, Double-Blind, Placebo-Controlled Dose Range-Finding Study to Assess Efficacy and Safety of Multiple Dose Levels of Inhaled AZD8630 Given Once Daily for 12 Weeks in Adults With Uncontrolled Asthma at Risk of Exacerbations (LEVANTE)
- ClinicalTrials.gov ID
- NCT06529419
- Acronym / sponsor ID
- Levante / D6830C00003
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 537 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A dose range-finding study to assess the efficacy and safety of multiple dose levels of AZD8630 administered via a dry powder inhaler in adults with uncontrolled asthma at risk of exacerbations, receiving medium -to -high dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA).
Detailed description
This is a Phase II, randomised, placebo-controlled, double-blind, dose range-finding, multi-centre study to assess the efficacy and safety of inhaled AZD8630 administered at 3 doses via an inhaler in adult patients with uncontrolled asthma, at risk of an exacerbation. The study duration up to 57 weeks for participants in the optional safety extension study and up to 17 weeks for those not included. The maximal treatment period is up to 52 weeks.
This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a parallel-group treatment study with 4 arms that is patient and Investigator blinded. Patients will be randomly assigned in a 1:1:1:1 ratio to one of the 4 treatment arms.
| Arm | Type | Receives |
|---|---|---|
| AZD8630 dose A | Experimental | Drug: AZD8630, Device: InhalerInhaled AZD8630 administered at a dose A |
| AZD8630 dose B | Experimental | Drug: AZD8630, Device: InhalerInhaled AZD8630 administered at a dose B |
| AZD8630 dose C | Experimental | Drug: AZD8630, Device: InhalerInhaled AZD8630 administered at a dose C |
| Placebo | Placebo comparator | Drug: Placebo, Device: InhalerInhaled placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8630The drug will be administered by inhalation | Drug | AZD8630 dose A, AZD8630 dose B, AZD8630 dose C |
| PlaceboThe placebo will be administered by inhalation | Drug | Placebo |
| InhalerThe drug/placebo will be administered by inhalation using the inhaler | Device | AZD8630 dose A, AZD8630 dose B, AZD8630 dose C, Placebo |
Primary outcome
Time to first CompEx Asthma event
Time frame: 12 weeks
The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables: * PEF * Asthma symptom score (0 to 3) * Use of rescue medication
5 secondary outcomes
Pre-BD FEV1
Time frame: 12 weeks
ACQ-6:
Time frame: 12 weeks
AQLQ12+
Time frame: 12 weeks
SGRQ
Time frame: 12 weeks
FeNO
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Njira Lugogo principal investigator
Univeristy of Michigan Hospital, Ann Arbor, MI, US
196 sites in 23 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD8630 and Inhaler in people with Asthma, run by AstraZeneca at 196 sites in 23 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 196 sites in United States, China, Japan, Ukraine, Argentina and 18 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first CompEx Asthma event (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.