Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
ACADIA
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)
1 other identifier
interventional
440
4 countries
135
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started May 2024
Longer than P75 for phase_3 asthma
135 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2024
CompletedStudy Start
First participant enrolled
May 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 13, 2027
May 1, 2026
April 1, 2026
3.4 years
March 6, 2024
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized rate of severe asthma exacerbations (AAER)
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
From Randomization (Day 1) to Week 52 (EOT)
Secondary Outcomes (12)
Time to first (TTF) severe asthma exacerbation
From Randomization (Day 1) to Week 52 (EOT)
Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma
From Randomization (Day 1) to Week 52 (EOT)
Number of participants with adverse events (AEs) and severe adverse events (SAEs)
Up to Week 52
Maximum Observed Concentration (Cmax)
At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Area under concentration-time curve from time 0 to last quantifiable concentration (AUClast)
At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
- +7 more secondary outcomes
Study Arms (2)
Budesonide/albuterol metered -dose inhaler (BDA MDI)
EXPERIMENTALParticipants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed.
Albuterol sulfate metered-dose inhaler (AS MDI)
ACTIVE COMPARATORParticipants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed.
Interventions
Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Experienced \> 3 severe asthma exacerbations within 12 months before screening.
- Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
- Upper respiratory infection involving antibiotic treatment not resolved.
- Current smokers, former smokers with \> 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana).
- Other significant lung disease, including regular or occasional use of oxygen.
- Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
- Cancer not in complete remission for at least 5 years.
- History or hospitalization for psychiatric disorder or attempted suicide within one year.
- Significant abuse of alcohol or drugs, in the opinion of the investigator.
- Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).
- Use of any oral SABAs within one month.
- Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Parexelcollaborator
- AstraZenecalead
Study Sites (135)
Research Site
Anchorage, Alaska, 99508, United States
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Gilbert, Arizona, 85234, United States
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Phoenix, Arizona, 85016, United States
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Little Rock, Arkansas, 72202, United States
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Long Beach, California, 90806, United States
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Long Beach, California, 90815, United States
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Madera, California, 93636, United States
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Mission Viejo, California, 92691, United States
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Moreno Valley, California, 92553, United States
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Orange, California, 92868, United States
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Riverside, California, 92506, United States
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San Diego, California, 92123, United States
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San Diego, California, 92123, United States
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San Francisco, California, 94143, United States
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Westminster, California, 92683, United States
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Denver, Colorado, 80206, United States
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Wilmington, Delaware, 19803, United States
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Destin, Florida, 32541, United States
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Jacksonville, Florida, 32207, United States
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Kendall, Florida, 33176, United States
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Largo, Florida, 33777, United States
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Miami, Florida, 33145, United States
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Pembroke Pines, Florida, 33026, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30329, United States
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Columbus, Georgia, 31904, United States
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Fayetteville, Georgia, 30214, United States
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Snellville, Georgia, 30078, United States
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Meridian, Idaho, 83646, United States
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Normal, Illinois, 61761, United States
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River Forest, Illinois, 60305, United States
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Indianapolis, Indiana, 46202, United States
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Kansas City, Kansas, 66160, United States
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Louisville, Kentucky, 40202, United States
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Lafayette, Louisiana, 70508, United States
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New Orleans, Louisiana, 70121, United States
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Ellicott City, Maryland, 21043, United States
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Silver Spring, Maryland, 20902, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48201, United States
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Mankato, Minnesota, 56001, United States
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Kansas City, Missouri, 64108, United States
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Kansas City, Missouri, 64118, United States
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Missoula, Montana, 59804, United States
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Lincoln, Nebraska, 68510, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68114, United States
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Newark, New Jersey, 07103, United States
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Northfield, New Jersey, 08225, United States
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Ocean City, New Jersey, 07712, United States
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Paramus, New Jersey, 07652, United States
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Albuquerque, New Mexico, 87106, United States
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Albany, New York, 12208, United States
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Cortland, New York, 13045, United States
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Hawthorne, New York, 10532, United States
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Hollis, New York, 11423, United States
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New York, New York, 10019, United States
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New York, New York, 10032, United States
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Rochester, New York, 14607, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10461, United States
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Vestal, New York, 13850, United States
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Vestal, New York, 13850, United States
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Watertown, New York, 13601, United States
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Charlotte, North Carolina, 28277, United States
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Cincinnati, Ohio, 45229, United States
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Columbus, Ohio, 43205, United States
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Columbus, Ohio, 43228, United States
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Dayton, Ohio, 45424, United States
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Findlay, Ohio, 45840, United States
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Toledo, Ohio, 43617, United States
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Oklahoma City, Oklahoma, 73104, United States
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Oklahoma City, Oklahoma, 73120, United States
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Yukon, Oklahoma, 73099, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Charleston, South Carolina, 29425, United States
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Rock Hill, South Carolina, 29730, United States
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Sioux Falls, South Dakota, 57105, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78759, United States
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Baytown, Texas, 77521, United States
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Beaumont, Texas, 77701, United States
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Beaumont, Texas, 77702, United States
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Bellaire, Texas, 77401, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75231, United States
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Frisco, Texas, 75034, United States
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Houston, Texas, 77065, United States
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Houston, Texas, 77099, United States
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Kerrville, Texas, 78028, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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Tyler, Texas, 75708, United States
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West Jordan, Utah, 84088, United States
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Burlington, Vermont, 05405, United States
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Burke, Virginia, 22015, United States
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Bellingham, Washington, 98225, United States
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Vancouver, Washington, 98664, United States
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Beijing, 100050, China
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Beijing, 100191, China
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Bengbu, 233004, China
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Chengdu, 610066, China
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Chongqing, 401122, China
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Hohhot, 10050, China
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Mianyang, 621000, China
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Shanghai, 200062, China
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Shanghai, 200433, China
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Shanghai, China
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Shantou, 515041, China
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Shenyang, 110004, China
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Shenzhen, 518026, China
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Suzhou, 215002, China
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Taizhou, 318000, China
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Tianjin, 300050, China
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Tianjin, 300134, China
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Tianjin, 300211, China
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Wuhan, 430000, China
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Yanji, 133000, China
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Yantai, 264000, China
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Zhongshan, 528400, China
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Chihuahua City, 31000, Mexico
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Chihuahua City, 31238, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44500, Mexico
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Monterrey, 64465, Mexico
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Durban, 3630, South Africa
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Durban, 4001, South Africa
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Durban, 4092, South Africa
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Krugersdorp, 1739, South Africa
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Middelburg, 1055, South Africa
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Panorama, 7500, South Africa
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Somerset West, 7130, South Africa
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Welkom, 9460, South Africa
Related Publications (1)
Bacharier LB, Raissy H, Bardsley S, Dunsire L, Hermansson E, Surujbally R, Sobande O, Murphy KR. Efficacy and safety of as-needed albuterol-budesonide versus albuterol in patients with asthma aged 12 to <18 years: design of the randomised, double-blind, parallel-group phase IIIb ACADIA trial. BMJ Open Respir Res. 2026 Mar 6;13(1):e003843. doi: 10.1136/bmjresp-2025-003843.
PMID: 41791845DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2024
First Posted
March 13, 2024
Study Start
May 20, 2024
Primary Completion (Estimated)
October 13, 2027
Study Completion (Estimated)
October 13, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.