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 Number: NCT06529419
Acronym: Levante
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Asthma
Interventions: DRUG: AZD8630|DRUG: Placebo|DEVICE: Inhaler
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 516
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2026-04-03
Locations: Research Site, Mesa, Arizona, 85213, United States|Research Site, Mission Viejo, California, 92691, United States|Research Site, DeBary, Florida, 32713, United States|Research Site, Jacksonville, Florida, 32216, United States|Research Site, Miami Lakes, Florida, 33014, United States|Research Site, Tampa, Florida, 33607, United States|Research Site, Kansas City, Kansas, 66160, United States|Research Site, Detroit, Michigan, 48202, United States|Research Site, Bellevue, Nebraska, 68123, United States|Research Site, Las Vegas, Nevada, 89102, United States|Research Site, Las Vegas, Nevada, 89119, United States|Research Site, Riverdale, New Jersey, 07457, United States|Research Site, Raleigh, North Carolina, 27607, United States|Research Site, Beavercreek, Ohio, 45431, United States|Research Site, Hatboro, Pennsylvania, 19040, United States|Research Site, Pottstown, Pennsylvania, 19464, United States|Research Site, Austin, Texas, 78704, United States|Research Site, Katy, Texas, 77450, United States|Research Site, McKinney, Texas, 75069, United States|Research Site, Pearland, Texas, 77584, United States|Research Site, American Fork, Utah, 84003, United States|Research Site, Roy, Utah, 84067, United States|Research Site, Salt Lake City, Utah, 84124, United States|Research Site, Milwaukee, Wisconsin, 53228, United States|Research Site, Berlin, 10119, Germany|Research Site, Bonn, 53127, Germany|Research Site, Essen, 45127, Germany|Research Site, Frankfurt, 60596, Germany|Research Site, Gießen, 35392, Germany|Research Site, Großhansdorf, 22927, Germany|Research Site, Landsberg, 86899, Germany|Research Site, Leipzig, 04207, Germany|Research Site, Mainz, 55128, Germany|Research Site, Marburg, 35037, Germany|Research Site, Kitakyusyu, 802-0052, Japan|Research Site, Mizunami-shi, 509-6134, Japan|Research Site, Shinjuku-ku, 162-8655, Japan|Research Site, Yanagawa-shi, 832-0059, Japan

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) and who have had ≥ 1 documented severe asthma exacerbation in the 12 months prior to enrolment.

Primary Outcome Measures: 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, 12 weeks