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)

Status: Recruiting
Location: See all (225) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

⁃ 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.

Locations
United States
Arizona
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Mesa
California
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Huntington Beach
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La Mesa
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Laguna Niguel
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Lancaster
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Long Beach
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San Diego
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San Jose
Colorado
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Aurora
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Englewood
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Lakewood
Connecticut
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New Haven
Florida
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Debary
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Jacksonville
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Jensen Beach
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Largo
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Miami
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Miami Lakes
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Tampa
Georgia
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Lilburn
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Savannah
Iowa
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Ames
Illinois
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Chicago
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Winfield
Kansas
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Kansas City
Louisiana
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Lafayette
Massachusetts
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Boston
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Methuen
Maryland
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Baltimore
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Baltimore
Michigan
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Ann Arbor
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Detroit
Minnesota
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Minneapolis
North Carolina
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Greenville
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Monroe
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Raleigh
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Winston-salem
Nebraska
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Bellevue
New Hampshire
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Portsmouth
New Jersey
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Riverdale
Nevada
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Las Vegas
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Las Vegas
New York
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Middletown
Ohio
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Beavercreek
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Lima
Oklahoma
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Oklahoma City
Pennsylvania
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Horsham
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Philadelphia
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Pottstown
South Carolina
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Greenville
Texas
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Abilene
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Austin
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Katy
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Laredo
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Mckinney
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Mesquite
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Pearland
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San Antonio
Utah
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American Fork
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Roy
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Salt Lake City
Virginia
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Hampton
Wisconsin
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Milwaukee
Other Locations
Argentina
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Alberdi
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Caba
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Capital Federal
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Mar Del Plata
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Quilmes
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Rosario
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San Fernando
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San Juan Bautista
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San Miguel De Tucumán
Belgium
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Duffel
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Mechelen
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Namur
Chile
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Chile
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Curicó
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Santiago
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Santiago
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Talca
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Viña Del Mar
China
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Baotou
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Changchun
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Chengdu
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Chifeng
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Chongqing
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Guangzhou
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Guiyang
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Hangzhou
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Hefei
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Hohhot
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Jinan
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Lanzhou
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Nanchang
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Ningbo
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Qingdao
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Shanghai
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Shenyang
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Shijiazhuang
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Taiyuan
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Wenzhou
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Xi'an
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Xuzhou
Denmark
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Aalborg
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Aarhus
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Hvidovre
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København Nv
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Odense
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Roskilde
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Vejle
France
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Lyon
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Marseille
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Nice
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Paris
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Reims
Germany
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Ahrensburg
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Berlin
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Bonn
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Essen
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Frankfurt
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Giessen
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Landsberg
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Leipzig
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Mainz
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Marburg
Hong Kong Special Administrative Region
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Hong Kong
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Hong Kong
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Hong Kong
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Lai Chi Kok
Israel
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Ashkelon
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Jerusalem
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Rehovot
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Tel Aviv
Italy
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Genoa
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Milan
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Roma
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Roma
Japan
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Chūōku
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Fukuoka
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Hiratsuka-shi
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Hiroshima
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Katsushika-ku
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Kitakyushu
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Kusatsu-shi
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Maebashi
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Maebashi
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Meguro-ku
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Mizunami-shi
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Nankoku-shi
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Niigata
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Sakaishi
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Sapporo
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Shinjuku-ku
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Toyoake-shi
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Yanagawa-shi
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Yokohama
Mexico
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Benito Juárez
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Culiacán
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NOT_YET_RECRUITING
Durango
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Guadalajara
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Mérida
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Monterrey
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Monterrey
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San Juan Del Río
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Villahermosa
Netherlands
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Alkmaar
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Amersfoort
Republic of Korea
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Daegu
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Daegu
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Iksan-si
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Seoul
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Seoul
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Seoul
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Seoul
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Suwon
Slovakia
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Kežmarok
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Košice
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Levice
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Levice
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Prešov
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Topoľčany
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Žilina
South Africa
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Cape Town
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Durban
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Emkhomazi
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Observatory
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Somerset West
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Tygervalley
Spain
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Barcelona
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Benalmádena
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Madrid
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Majadahonda
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Málaga
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Palma De Mallorca
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Santander
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Valencia
Taiwan
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Kaohsiung City
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Taichung
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Taichung
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Taichung
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Taipei
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Taipei
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Taipei
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Taoyuan District
Turkey
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Adana
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NOT_YET_RECRUITING
Altındağ-ankara
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Ankara
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Istanbul
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Kırıkkale
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Mersin
Ukraine
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Chernivtsі
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Ivano-frankivsk
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Ivano-frankivsk
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Lutsk
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Lutsk
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Uzhhorod
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Vinnytsia
United Kingdom
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Bradford
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Liverpool
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Portsmouth
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2026-04-06
Participants
Target number of participants: 516
Treatments
Experimental: AZD8630 dose A
Inhaled AZD8630 administered at a dose A
Experimental: AZD8630 dose B
Inhaled AZD8630 administered at a dose B
Experimental: AZD8630 dose C
Inhaled AZD8630 administered at a dose C
Placebo_comparator: Placebo
Inhaled placebo
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov