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

Last updated: January 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

AZD8630

Inhaler

Placebo

Clinical Study ID

NCT06529419
D6830C00003
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

  3. Uncontrolled asthma (i.e. ACQ-6 ≥ 1.5)

  4. Pre-BD FEV1 ≥ 40%

  5. A history of asthma exacerbations within the last 12 months

  6. & 9. Compliant with asthma background mediation, daily ePROs and daily home spirometry.

  7. BMI within the range 18-37 kg/m2 (inclusive)

  8. Female patients of child bearing potential must not be pregnant and agree to use highly effective contraception.

  9. Male patients and their female partners of childbearing potential must agree to use highly effective contraception.

  10. 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:

  5. Affect the safety of the patient throughout the study

  6. Influence the findings of the study or their interpretation

  7. Impede the patient's ability to complete the entire duration of study

  8. Patients who, in the opinion of the Investigator, have evidence of active TB or are currently on treatment for active or latent TB.

  9. Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C

  10. Patients with history of HIV infection or who test positive for HIV.

  11. Congenital long QT syndrome or prolonged QTcF > 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.

  12. Current untreated or uncontrolled arrhythmia.

  13. Patients with recent myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention or coronary artery bypass grafting.

  14. A helminth parasitic infection diagnosed that has not been treated, or has not responded to SoC therapy.

  15. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months ago.

  16. Known history of drug or alcohol abuse within 12 months, that in the Investigator's opinion would preclude participation in the study.

  17. Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years.

  18. 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.

  19. Treatment with marketed or investigational biologics within 4 months or a minimum of 5 half-lives.

  20. Treatment with Systemic steroids within 4 weeks.

  21. Chronic oral or systemic CS use for asthma or for any other indication (with the exception of stable replacement therapy in adrenal insufficiency).

Study Design

Total Participants: 516
Treatment Group(s): 3
Primary Treatment: AZD8630
Phase: 2
Study Start date:
August 30, 2024
Estimated Completion Date:
April 06, 2026

Study 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

Connect with a study center

  • Research Site

    Alberdi, X5033DCE
    Argentina

    Site Not Available

  • Research Site

    Caba, C1426
    Argentina

    Site Not Available

  • Research Site

    Capital Federal, C1060ABN
    Argentina

    Site Not Available

  • Research Site

    Florencio Varela, 1888
    Argentina

    Site Not Available

  • Research Site

    Mar del Plata, 7600
    Argentina

    Site Not Available

  • Research Site

    Quilmes, B1878FNR
    Argentina

    Site Not Available

  • Research Site

    Rosario, 2000
    Argentina

    Site Not Available

  • Research Site

    San Fernando, B1646EBJ
    Argentina

    Site Not Available

  • Research Site

    San Miguel de Tucuman, 4000
    Argentina

    Site Not Available

  • Research Site

    Duffel, 2570
    Belgium

    Site Not Available

  • Research Site

    Mechelen, 2800
    Belgium

    Site Not Available

  • Research Site

    Namur, 5101
    Belgium

    Site Not Available

  • Research Site

    Curico, 3341643
    Chile

    Site Not Available

  • Research Site

    Santiago, 7500691
    Chile

    Site Not Available

  • Research Site

    Talca, 3465584
    Chile

    Site Not Available

  • Research Site

    Viña del Mar, 2540488
    Chile

    Site Not Available

  • Research Site

    Anhui, 230061
    China

    Site Not Available

  • Research Site

    Changchun, 130021
    China

    Site Not Available

  • Research Site

    Chifeng, 024005
    China

    Site Not Available

  • Research Site

    Guangzhou, 510163
    China

    Site Not Available

  • Research Site

    Guiyang, 510630
    China

    Site Not Available

  • Research Site

    Hangzhou, 310009
    China

    Site Not Available

  • Research Site

    Hohhot, 610078
    China

    Site Not Available

  • Research Site

    Lanzhou, 730000
    China

    Site Not Available

  • Research Site

    Ningbo, 315010
    China

    Site Not Available

  • Research Site

    Shanghai, 200080
    China

    Site Not Available

  • Research Site

    Shenyang, 110004
    China

    Site Not Available

  • Research Site

    Taiyuan, 030032
    China

    Site Not Available

  • Research Site

    Wenzhou, 325027
    China

    Site Not Available

  • Research Site

    Xi'an, 710006
    China

    Site Not Available

  • Research Site

    Xuzhou, 221000
    China

    Site Not Available

  • Research Site

    Brno, 62500
    Czechia

    Site Not Available

  • Research Site

    Hradec Králové, 50005
    Czechia

    Site Not Available

  • Research Site

    Jindrichuv Hradec, 377 01
    Czechia

    Site Not Available

  • Research Site

    Kralupy nad Vltavou, 278 01
    Czechia

    Site Not Available

  • Research Site

    Plzeň, 32300
    Czechia

    Site Not Available

  • Research Site

    Praha 16, 15300
    Czechia

    Site Not Available

  • Research Site

    Teplice, 415 01
    Czechia

    Site Not Available

  • Research Site

    Varnsdorf, 407 47
    Czechia

    Site Not Available

  • Research Site

    Aalborg, 9100
    Denmark

    Site Not Available

  • Research Site

    Aarhus, 8200
    Denmark

    Site Not Available

  • Research Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Research Site

    København NV, 2400
    Denmark

    Site Not Available

  • Research Site

    Odense, 5000
    Denmark

    Site Not Available

  • Research Site

    Roskilde, 4000
    Denmark

    Site Not Available

  • Research Site

    Vejle, 7100
    Denmark

    Site Not Available

  • Research Site

    Lyon Cedex 04, 69317
    France

    Site Not Available

  • Research Site

    Marseille, 13915
    France

    Site Not Available

  • Research Site

    Nice Cedex 01, F-06002
    France

    Site Not Available

  • Research Site

    Paris, 75018
    France

    Site Not Available

  • Research Site

    Reims, 51092
    France

    Site Not Available

  • Research Site

    Ahrensburg, 22926
    Germany

    Site Not Available

  • Research Site

    Berlin, 10119
    Germany

    Site Not Available

  • Research Site

    Bonn, 53127
    Germany

    Site Not Available

  • Research Site

    Essen, 45239
    Germany

    Site Not Available

  • Research Site

    Frankfurt, 60596
    Germany

    Site Not Available

  • Research Site

    Giessen, 35392
    Germany

    Site Not Available

  • Research Site

    Gießen, 35392
    Germany

    Site Not Available

  • Research Site

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Research Site

    Landsberg, 86899
    Germany

    Site Not Available

  • Research Site

    Leipzig, 04207
    Germany

    Site Not Available

  • Research Site

    Mainz, 55128
    Germany

    Site Not Available

  • Research Site

    Marburg, 35037
    Germany

    Site Not Available

  • Research Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • Research Site

    Lai Chi Kok,
    Hong Kong

    Site Not Available

  • Research Site

    Ashkelon, 78278
    Israel

    Site Not Available

  • Research Site

    Jerusalem, 9372212
    Israel

    Site Not Available

  • Research Site

    Rehovot, 76100
    Israel

    Site Not Available

  • Research Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Research Site

    Genoa, 16132
    Italy

    Site Not Available

  • Research Site

    Milano, 20122
    Italy

    Site Not Available

  • Research Site

    Roma, 00168
    Italy

    Site Not Available

  • Research Site

    Rome, 00168
    Italy

    Site Not Available

  • Research Site

    Chuo-ku, 104-0031
    Japan

    Active - Recruiting

  • Research Site

    Fukuoka-shi, 819-8555
    Japan

    Site Not Available

  • Research Site

    Hiratsuka-shi, 254-8502
    Japan

    Active - Recruiting

  • Research Site

    Katsushika-ku, 125-0061
    Japan

    Site Not Available

  • Research Site

    Kitakyusyu, 802-0052
    Japan

    Active - Recruiting

  • Research Site

    Kusatsu-shi, 525-8585
    Japan

    Site Not Available

  • Research Site

    Maebashi, 371-0048
    Japan

    Site Not Available

  • Research Site

    Maebashi-shi, 371-0054
    Japan

    Site Not Available

  • Research Site

    Meguro-ku, 153-8515
    Japan

    Site Not Available

  • Research Site

    Mizunami-shi, 509-6134
    Japan

    Active - Recruiting

  • Research Site

    Nankoku-shi, 783-8509
    Japan

    Site Not Available

  • Research Site

    Niigata-shi, 950-1197
    Japan

    Active - Recruiting

  • Research Site

    Sakai-shi, 591-8555
    Japan

    Site Not Available

  • Research Site

    Sapporo-shi, 064-0804
    Japan

    Active - Recruiting

  • Research Site

    Shinjuku-ku, 162-8655
    Japan

    Site Not Available

  • Research Site

    Toyoake-shi, 470-1192
    Japan

    Site Not Available

  • Research Site

    Yanagawa-shi, 832-0059
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 236-0037
    Japan

    Site Not Available

  • Research Site

    Daegu, 42415
    Korea, Republic of

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  • Research Site

    Iksan-si, 54538
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03312
    Korea, Republic of

    Site Not Available

  • Research Site

    Suwon-si, 16499
    Korea, Republic of

    Site Not Available

  • Research Site

    Benito Juarez, 03103
    Mexico

    Site Not Available

  • Research Site

    Culiacan, 80100
    Mexico

    Site Not Available

  • Research Site

    Durango, 34200
    Mexico

    Site Not Available

  • Research Site

    Guadalajara, 44130
    Mexico

    Site Not Available

  • Research Site

    Monterrey, 64040
    Mexico

    Site Not Available

  • Research Site

    Mérida, 97070
    Mexico

    Site Not Available

  • Research Site

    San Juan del Rio, 76800
    Mexico

    Site Not Available

  • Research Site

    Villahermosa, 86035
    Mexico

    Site Not Available

  • Research Site

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Research Site

    Amersfoort, 3813 TZ
    Netherlands

    Site Not Available

  • Research Site

    Kezmarok, 060 01
    Slovakia

    Site Not Available

  • Research Site

    Kosice, 04022
    Slovakia

    Site Not Available

  • Research Site

    Levice, 934 01
    Slovakia

    Site Not Available

  • Research Site

    Presov, 081 81
    Slovakia

    Site Not Available

  • Research Site

    Topolcany, 95501
    Slovakia

    Site Not Available

  • Research Site

    Topoľčany, 955 01
    Slovakia

    Site Not Available

  • Research Site

    Zilina, 010 01
    Slovakia

    Site Not Available

  • Research Site

    Cape Town, 7700
    South Africa

    Site Not Available

  • Research Site

    Durban, 4001
    South Africa

    Site Not Available

  • Research Site

    Observatory, 7925
    South Africa

    Site Not Available

  • Research Site

    Somerset West, 7130
    South Africa

    Site Not Available

  • Research Site

    Tygervalley, 7530
    South Africa

    Site Not Available

  • Research Site

    Umkomaas, 4170
    South Africa

    Site Not Available

  • Research Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Research Site

    Benalmádena, 29631
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Site Not Available

  • Research Site

    Majadahonda, 28222
    Spain

    Site Not Available

  • Research Site

    Málaga, 29010
    Spain

    Site Not Available

  • Research Site

    Palma de Mallorca, 07010
    Spain

    Site Not Available

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Valencia, 46010
    Spain

    Site Not Available

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40201
    Taiwan

    Site Not Available

  • Research Site

    Taichung City, 433004
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 110
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Adana, 1330
    Turkey

    Site Not Available

  • Research Site

    Ankara,
    Turkey

    Site Not Available

  • Research Site

    Istanbul, 34854
    Turkey

    Site Not Available

  • Research Site

    Kırıkkale, 71450
    Turkey

    Site Not Available

  • Research Site

    Mersin, 33079
    Turkey

    Site Not Available

  • Research Site

    Chernivtsі, 58000
    Ukraine

    Site Not Available

  • Research Site

    Ivano-Frankivsk, 76019
    Ukraine

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  • Research Site

    Kyiv, 03680
    Ukraine

    Site Not Available

  • Research Site

    Lutsk, 43000
    Ukraine

    Site Not Available

  • Research Site

    Uzhhorod, 88018
    Ukraine

    Active - Recruiting

  • Research Site

    Vinnytsia, 21029
    Ukraine

    Site Not Available

  • Research Site

    Bradford, BD9 6RJ
    United Kingdom

    Site Not Available

  • Research Site

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Research Site

    Portsmouth, PO6 3LY
    United Kingdom

    Active - Recruiting

  • Research Site

    Mesa, Arizona 85213
    United States

    Active - Recruiting

  • Research Site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Research Site

    La Mesa, California 91942
    United States

    Active - Recruiting

  • Research Site

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Research Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Research Site

    Long Beach, California 90815
    United States

    Site Not Available

  • Research Site

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Research Site

    San Diego, California 92120
    United States

    Site Not Available

  • Research Site

    San Jose, California 95117
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Research Site

    Lakewood, Colorado 80228
    United States

    Site Not Available

  • Research Site

    North Haven, Connecticut 06473
    United States

    Site Not Available

  • Research Site

    DeBary, Florida 32713
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Research Site

    Jensen Beach, Florida 34957
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33135
    United States

    Site Not Available

  • Research Site

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Research Site

    Seminole, Florida 33777
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Research Site

    Lilburn, Georgia 30047
    United States

    Active - Recruiting

  • Research Site

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60616
    United States

    Site Not Available

  • Research Site

    Winfield, Illinois 60190
    United States

    Site Not Available

  • Research Site

    Ames, Iowa 50010
    United States

    Site Not Available

  • Research Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Research Site

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Research Site

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Research Site

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Research Site

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Research Site

    Bellevue, Nebraska 68123
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Research Site

    Portsmouth, New Hampshire 03801
    United States

    Site Not Available

  • Research Site

    Riverdale, New Jersey 07457
    United States

    Site Not Available

  • Research Site

    Middletown, New York 10941
    United States

    Site Not Available

  • Research Site

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Research Site

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

  • Research Site

    Beavercreek, Ohio 45431
    United States

    Active - Recruiting

  • Research Site

    Lima, Ohio 45801
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Research Site

    Hatboro, Pennsylvania 19040
    United States

    Site Not Available

  • Research Site

    Horsham, Pennsylvania 19044
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Research Site

    Pottstown, Pennsylvania 19464
    United States

    Active - Recruiting

  • Research Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Research Site

    Abilene, Texas 79606
    United States

    Site Not Available

  • Research Site

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Research Site

    Katy, Texas 77450
    United States

    Active - Recruiting

  • Research Site

    Laredo, Texas 78041
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Research Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Research Site

    Pearland, Texas 77584
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Research Site

    American Fork, Utah 84003
    United States

    Active - Recruiting

  • Research Site

    Roy, Utah 84067
    United States

    Active - Recruiting

  • Research Site

    Salt Lake City, Utah 84124
    United States

    Active - Recruiting

  • Research Site

    Hampton, Virginia 23666
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53228
    United States

    Active - Recruiting

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