A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)

Status: Recruiting
Location: See all (124) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Confirmed clinical diagnosis of asthma at least 12 months.

• Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month

‣ Low-to-high-dose Inhaled corticosteroid(s) (ICS)

⁃ Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline

• Receiving inhaled short-acting β2-agonist (SABA) as needed.

• A documented history of at least one severe asthma exacerbation within 12 months.

• Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.

• Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.

• Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.

• Participants must adhere to protocol specific contraception methods.

• Negative urine pregnancy test for participants of childbearing potential.

• Have a BMI \< 40 kg/ m\^2.

• Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.

Locations
United States
Alaska
Research Site
RECRUITING
Anchorage
Arkansas
Research Site
RECRUITING
Little Rock
Arizona
Research Site
RECRUITING
Gilbert
Research Site
NOT_YET_RECRUITING
Phoenix
California
Research Site
RECRUITING
Long Beach
Research Site
NOT_YET_RECRUITING
Madera
Research Site
RECRUITING
Mission Viejo
Research Site
RECRUITING
Moreno Valley
Research Site
RECRUITING
Orange
Research Site
RECRUITING
Riverside
Research Site
RECRUITING
San Diego
Research Site
NOT_YET_RECRUITING
San Diego
Research Site
NOT_YET_RECRUITING
San Francisco
Research Site
RECRUITING
Westminster
Colorado
Research Site
RECRUITING
Denver
Delaware
Research Site
RECRUITING
Wilmington
Florida
Research Site
RECRUITING
Destin
Research Site
RECRUITING
Jacksonville
Research Site
RECRUITING
Largo
Research Site
RECRUITING
Miami
Research Site
NOT_YET_RECRUITING
Tampa
Georgia
Research Site
NOT_YET_RECRUITING
Atlanta
Research Site
RECRUITING
Columbus
Research Site
RECRUITING
Fayetteville
Idaho
Research Site
NOT_YET_RECRUITING
Meridian
Illinois
Research Site
RECRUITING
Normal
Research Site
NOT_YET_RECRUITING
River Forest
Indiana
Research Site
RECRUITING
Indianapolis
Kansas
Research Site
RECRUITING
Kansas City
Kentucky
Research Site
RECRUITING
Louisville
Louisiana
Research Site
RECRUITING
Lafayette
Research Site
RECRUITING
New Orleans
Massachusetts
Research Site
NOT_YET_RECRUITING
Boston
Maryland
Research Site
RECRUITING
Ellicott City
Research Site
RECRUITING
Silver Spring
Research Site
RECRUITING
White Marsh
Michigan
Research Site
RECRUITING
Detroit
Minnesota
Research Site
RECRUITING
Mankato
Missouri
Research Site
RECRUITING
Kansas City
Research Site
NOT_YET_RECRUITING
Kansas City
Montana
Research Site
RECRUITING
Missoula
North Carolina
Research Site
NOT_YET_RECRUITING
Charlotte
Nebraska
Research Site
RECRUITING
Lincoln
Research Site
RECRUITING
Lincoln
Research Site
RECRUITING
Omaha
New Jersey
Research Site
RECRUITING
Newark
Research Site
RECRUITING
Northfield
Research Site
RECRUITING
Ocean City
Research Site
RECRUITING
Paramus
New Mexico
Research Site
RECRUITING
Albuquerque
New York
Research Site
RECRUITING
Albany
Research Site
RECRUITING
Cortland
Research Site
RECRUITING
Hawthorne
Research Site
NOT_YET_RECRUITING
Hollis
Research Site
RECRUITING
New York
Research Site
NOT_YET_RECRUITING
New York
Research Site
RECRUITING
Rochester
Research Site
RECRUITING
The Bronx
Research Site
RECRUITING
The Bronx
Research Site
NOT_YET_RECRUITING
Vestal
Research Site
RECRUITING
Vestal
Research Site
RECRUITING
Watertown
Ohio
Research Site
NOT_YET_RECRUITING
Cincinnati
Research Site
NOT_YET_RECRUITING
Columbus
Research Site
RECRUITING
Dayton
Research Site
RECRUITING
Findlay
Research Site
RECRUITING
Toledo
Oklahoma
Research Site
RECRUITING
Oklahoma City
Research Site
RECRUITING
Oklahoma City
Research Site
RECRUITING
Yukon
Pennsylvania
Research Site
RECRUITING
Pittsburgh
South Carolina
Research Site
RECRUITING
Charleston
Research Site
RECRUITING
Rock Hill
South Dakota
Research Site
RECRUITING
Sioux Falls
Tennessee
Research Site
RECRUITING
Nashville
Texas
Research Site
RECRUITING
Austin
Research Site
RECRUITING
Baytown
Research Site
RECRUITING
Beaumont
Research Site
RECRUITING
Corsicana
Research Site
RECRUITING
Dallas
Research Site
NOT_YET_RECRUITING
Frisco
Research Site
RECRUITING
Houston
Research Site
RECRUITING
Houston
Research Site
NOT_YET_RECRUITING
Kerrville
Research Site
RECRUITING
Mckinney
Research Site
RECRUITING
San Antonio
Research Site
RECRUITING
San Antonio
Research Site
RECRUITING
Tyler
Utah
Research Site
RECRUITING
West Jordan
Virginia
Research Site
RECRUITING
Burke
Vermont
Research Site
RECRUITING
Burlington
Washington
Research Site
RECRUITING
Bellingham
Research Site
RECRUITING
Vancouver
Other Locations
China
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Beijing
Research Site
RECRUITING
Bengbu
Research Site
RECRUITING
Chengdu
Research Site
RECRUITING
Chongqing
Research Site
RECRUITING
Hohhot
Research Site
RECRUITING
Mianyang
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Shenyang
Research Site
RECRUITING
Shenzhen
Research Site
RECRUITING
Suzhou
Research Site
RECRUITING
Taizhou
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Tianjin
Research Site
RECRUITING
Wuhan
Research Site
RECRUITING
Yanji
Research Site
RECRUITING
Yantai
Research Site
RECRUITING
Zhongshan
Mexico
Research Site
NOT_YET_RECRUITING
Chihuahua City
Research Site
NOT_YET_RECRUITING
Chihuahua City
Research Site
NOT_YET_RECRUITING
Monterrey
South Africa
Research Site
NOT_YET_RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Krugersdorp
Research Site
NOT_YET_RECRUITING
Middelburg
Research Site
NOT_YET_RECRUITING
Panorama
Research Site
NOT_YET_RECRUITING
Somerset West
Research Site
NOT_YET_RECRUITING
Welkom
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2027-10-13
Participants
Target number of participants: 440
Treatments
Experimental: Budesonide/albuterol metered -dose inhaler (BDA MDI)
Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
Active_comparator: Albuterol sulfate metered-dose inhaler (AS MDI)
Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Parexel

This content was sourced from clinicaltrials.gov