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
NCT ID: NCT06529419
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
534 participants
INTERVENTIONAL
2024-08-30
2026-02-04
Brief Summary
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Detailed Description
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This study will be conducted in approximately 220 centres in 20-25 countries. Approximately 516 patients will be randomised globally
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AZD8630 dose A
Inhaled AZD8630 administered at a dose A
AZD8630
The drug will be administered by inhalation
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
AZD8630 dose B
Inhaled AZD8630 administered at a dose B
AZD8630
The drug will be administered by inhalation
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
AZD8630 dose C
Inhaled AZD8630 administered at a dose C
AZD8630
The drug will be administered by inhalation
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
Placebo
Inhaled placebo
Placebo
The placebo will be administered by inhalation
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
Interventions
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AZD8630
The drug will be administered by inhalation
Placebo
The placebo will be administered by inhalation
Inhaler
The drug/placebo will be administered by inhalation using the inhaler
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Njira Lugogo
Role: PRINCIPAL_INVESTIGATOR
Univeristy of Michigan Hospital, Ann Arbor, MI, US
Locations
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Research Site
Mesa, Arizona, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Laguna Niguel, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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San Jose, California, United States
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New Haven, Connecticut, United States
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DeBary, Florida, United States
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Jacksonville, Florida, United States
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Jensen Beach, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Tampa, Florida, United States
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Lilburn, Georgia, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Winfield, Illinois, United States
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Ames, Iowa, United States
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Kansas City, Kansas, United States
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Baltimore, Maryland, United States
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Methuen, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Riverdale, New Jersey, United States
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Middletown, New York, United States
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Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Beavercreek, Ohio, United States
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Lima, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Horsham, Pennsylvania, United States
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Austin, Texas, United States
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McKinney, Texas, United States
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Mesquite, Texas, United States
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Pearland, Texas, United States
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San Antonio, Texas, United States
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American Fork, Utah, United States
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Roy, Utah, United States
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Salt Lake City, Utah, United States
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Hampton, Virginia, United States
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Milwaukee, Wisconsin, United States
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Alberdi, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Fernando, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Duffel, , Belgium
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Mechelen, , Belgium
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Namur, , Belgium
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Chile, , Chile
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Curicó, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Viña del Mar, , Chile
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Baotou, , China
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Changchun, , China
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Chengdu, , China
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Chongqing, , China
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Guangzhou, , China
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Guiyang, , China
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Hefei, , China
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Hohhot, , China
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Jinan, , China
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Lanzhou, , China
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Nanchang, , China
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Ningbo, , China
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Qingdao, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Taiyuan, , China
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Wenzhou, , China
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Xuzhou, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
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Kralupy nad Vltavou, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Varnsdorf, , Czechia
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Aalborg, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Vejle, , Denmark
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Lyon, , France
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Marseille, , France
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Nice, , France
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Paris, , France
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Reims, , France
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Berlin, , Germany
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Bonn, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Marburg, , Germany
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Hong Kong, , Hong Kong
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Ashkelon, , Israel
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Jerusalem, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Genoa, , Italy
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Milan, , Italy
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Roma, , Italy
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Roma, , Italy
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Chūōku, , Japan
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Fukuoka, , Japan
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Hiratsuka-shi, , Japan
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Hiroshima, , Japan
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Kitakyushu, , Japan
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Kusatsu-shi, , Japan
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Maebashi, , Japan
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Maebashi, , Japan
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Meguro-ku, , Japan
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Mizunami-shi, , Japan
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Nankoku-shi, , Japan
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Niigata, , Japan
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Sakaishi, , Japan
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Sapporo, , Japan
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Shinjuku-ku, , Japan
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Toyoake-shi, , Japan
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Yanagawa-shi, , Japan
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Yokohama, , Japan
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Durango, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Villahermosa, , Mexico
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Alkmaar, , Netherlands
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Amersfoort, , Netherlands
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Kežmarok, , Slovakia
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Košice, , Slovakia
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Levice, , Slovakia
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Prešov, , Slovakia
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Topoľčany, , Slovakia
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Topoľčany, , Slovakia
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Žilina, , Slovakia
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Cape Town, , South Africa
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Durban, , South Africa
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eMkhomazi, , South Africa
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Observatory, , South Africa
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Somerset West, , South Africa
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Tygervalley, , South Africa
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Daegu, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Benalmádena, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
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Santander, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Adana, , Turkey (Türkiye)
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Altındağ-Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kırıkkale, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Bradford, , United Kingdom
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Liverpool, , United Kingdom
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Portsmouth, , United Kingdom
Countries
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Other Identifiers
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D6830C00003
Identifier Type: -
Identifier Source: org_study_id
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