A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma

Status: Recruiting
Location: See all (143) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant must be ≥ 18 years of age at the time of signing the ICF.

• Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1.

• Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.

• Participants with a pre-bronchodilator FEV1 of ≥ 60% and \< 90% predicted normal at Visit 1 or Visit 1a.

• Participants with a pre-dose FEV1 of ≥ 60% and \< 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.

• Participants who demonstrate bronchodilator responsiveness defined as a \> 12% and \> 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a.

• Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update

• Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.

• Participants with a body mass index \< 40 kg/m2.

• Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control

Locations
United States
Alabama
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Mobile
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Sheffield
Arkansas
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Little Rock
Arizona
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Phoenix
California
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Encinitas
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Fullerton
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Gardena
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Huntington Beach
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La Mesa
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Los Angeles
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Los Angeles
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Sacramento
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San Bernardino
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San Diego
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San Jose
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TERMINATED
Santa Ana
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Stockton
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Van Nuys
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Westminster
Colorado
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Englewood
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Wheat Ridge
Washington, D.c.
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Washington D.c.
Florida
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Boynton Beach
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Miami
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Tallahassee
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Tampa
Georgia
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Atlanta
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Rincon
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Savannah
Iowa
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Sioux City
Idaho
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Boise
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Meridian
Illinois
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River Forest
Indiana
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Evansville
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Valparaiso
Kentucky
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Louisville
Louisiana
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Lafayette
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New Orleans
Maryland
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White Marsh
Michigan
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Flint
Missouri
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Columbia
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St Louis
North Carolina
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Charlotte
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Raleigh
Nebraska
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Omaha
New York
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COMPLETED
Monticello
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New York
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Watertown
Ohio
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Cincinnati
Oklahoma
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Oklahoma City
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Tulsa
Oregon
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Medford
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Portland
Pennsylvania
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Pottstown
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Scottdale
South Carolina
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Charleston
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Greenville
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North Charleston
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Spartanburg
Texas
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Boerne
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Dallas
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Desoto
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El Paso
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Kingwood
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NOT_YET_RECRUITING
Mckinney
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Pearland
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San Antonio
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Victoria
Utah
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West Jordan
Virginia
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Burke
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Portsmouth
Washington
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Spokane
Wisconsin
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Milwaukee
West Virginia
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Morgantown
Other Locations
China
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Baotou
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Changsha
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Chengdu
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Chizhou
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Chongqing
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Guangzhou
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Guangzhou
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Haikou
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Hangzhou
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Hefei
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Hohhot
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Huizhou
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Jinan
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Jinhua
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Lanzhou
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Linhai
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Nanchang
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Pingxiang
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Qingdao
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Shanghai
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Shanghai
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Shanghai
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Shenyang
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Shenzhen
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Shijiazhuang
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Taiyuan
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Taiyuan
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Wenzhou
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Wuhan
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Xi'an
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Xuzhou
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Xuzhou
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Yangzhou
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Yinchuan
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Zhengzhou
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Zhuji
Malaysia
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Alor Star
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Ampang
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Cheras
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Petaling Jaya
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Rawang
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Sandakan
Mexico
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Chihuahua City
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Cuernavaca
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Culiacán
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Durango
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Guadalajara
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Guadalajara
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Mazatlán
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Mérida
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Mexico City
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Monterrey
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Monterrey
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San Juan Del Río
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Tijuana
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Veracruz
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Zapopan
Thailand
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Bangkoknoi
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Khon Kaen
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Mueang
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Ratchathewi
United Arab Emirates
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Abu Dhabi
United Kingdom
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Ashton-under-lyne
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Glasgow
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Newcastle Upon Tyne
Viet Nam
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Can Tho
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Haiphong
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Hanoi
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Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-07-22
Estimated Completion Date: 2026-03-03
Participants
Target number of participants: 398
Treatments
Active_comparator: BDA MDI HFO
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO
Active_comparator: BDA MDI HFA
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo_comparator: Placebo MDI HFA
Placebo pressurized inhalation suspension, HFA
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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