AsthmaPhase 3ACADIANCT06307665
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
A Phase 3 study testing BDA MDI and AS MDI in people with Asthma, run by AstraZeneca at 155 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- BDA MDI and AS MDI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 155 sitesin 4 countries
- Study dates
- 20 May 2024to 13 Oct 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
155 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
155 sites in 4 countries
United States120 sites, 101 recruiting
- Recruiting
Research Site
Albany, New York, 12208
- Recruiting
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Albuquerque, New Mexico, 87106
- Recruiting
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Anchorage, Alaska, 99508
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Atlanta, Georgia, 30329
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Austin, Texas, 78759
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Baytown, Texas, 77521
- Recruiting
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Beaumont, Texas, 77701
- Not yet recruiting
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Beaumont, Texas, 77702
- Recruiting
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Bellaire, Texas, 77401
- Completed
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Bellingham, Washington, 98225
- Not yet recruiting
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Boston, Massachusetts, 02114
- Withdrawn
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Burke, Virginia, 22015
- Recruiting
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Burlington, Vermont, 05405
- Recruiting
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Charleston, South Carolina, 29425
- Withdrawn
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Charlotte, North Carolina, 28277
- Not yet recruiting
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Cincinnati, Ohio, 45229
- Recruiting
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Columbus, Georgia, 31904
- Not yet recruiting
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Columbus, Ohio, 43205
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Columbus, Ohio, 43228
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Corpus Christi, Texas, 78411
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Corsicana, Texas, 75110
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Cortland, New York, 13045
- Recruiting
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Dallas, Texas, 75231
- Not yet recruiting
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Dallas, Texas, 75235
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Dayton, Ohio, 45424
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Denver, Colorado, 80206
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Destin, Florida, 32541
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Detroit, Michigan, 48201
- Not yet recruiting
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Durham, North Carolina, 27705
- Recruiting
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El Paso, Texas, 79912
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Ellicott City, Maryland, 21043
- Recruiting
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Fayetteville, Georgia, 30214
- Recruiting
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Findlay, Ohio, 45840
- Withdrawn
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Frisco, Texas, 75034
- Recruiting
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Gilbert, Arizona, 85234
- Recruiting
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Hawthorne, New York, 10532
- Withdrawn
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Hollis, New York, 11423
- Not yet recruiting
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Houston, Texas, 77030
- Recruiting
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Houston, Texas, 77065
- Recruiting
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Houston, Texas, 77099
- Not yet recruiting
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Huntington Beach, California, 92647
- Not yet recruiting
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Huntington Beach, California, 92648
- Recruiting
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Indianapolis, Indiana, 46202
- Recruiting
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Jacksonville, Florida, 32207
- Recruiting
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Kansas City, Kansas, 66160
- Withdrawn
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Kansas City, Missouri, 64108
- Recruiting
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Kansas City, Missouri, 64118
- Not yet recruiting
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Kendall, Florida, 33176
- Withdrawn
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Kerrville, Texas, 78028
- Recruiting
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Lafayette, Louisiana, 70508
- Not yet recruiting
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Lanham, Maryland, 20706
- Completed
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Largo, Florida, 33777
- Recruiting
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Lincoln, Nebraska, 68510
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Lincoln, Nebraska, 68516
- Completed
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Little Rock, Arkansas, 72202
- Recruiting
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Long Beach, California, 90806
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Long Beach, California, 90815
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40217
- Not yet recruiting
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Madera, California, 93636
- Active, not recruiting
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Mankato, Minnesota, 56001
- Recruiting
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McKinney, Texas, 75069
- Withdrawn
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Meridian, Idaho, 83646
- Recruiting
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Miami, Florida, 33142
- Recruiting
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Miami, Florida, 33144
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Miami, Florida, 33145
- Not yet recruiting
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Miami, Florida, 33183
- Recruiting
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Miami, Florida, 33185
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Mission Viejo, California, 92691
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Missoula, Montana, 59804
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Moreno Valley, California, 92553
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Nashville, Tennessee, 37232
- Recruiting
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New Orleans, Louisiana, 70121
- Recruiting
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New Orleans, Louisiana, 70125
- Withdrawn
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New York, New York, 10019
- Recruiting
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New York, New York, 10032
- Not yet recruiting
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New York, New York, 11355
- Recruiting
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Newark, New Jersey, 07103
- Recruiting
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Normal, Illinois, 61761
- Recruiting
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Northfield, New Jersey, 08225
- Recruiting
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Ocean City, New Jersey, 07712
- Recruiting
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Oklahoma City, Oklahoma, 73104
- Not yet recruiting
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Oklahoma City, Oklahoma, 73104
- Recruiting
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Oklahoma City, Oklahoma, 73120
- Recruiting
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Omaha, Nebraska, 68114
- Recruiting
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Orange, California, 92868
- Not yet recruiting
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Orlando, Florida, 32827
- Recruiting
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Paramus, New Jersey, 07652
- Recruiting
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Pembroke Pines, Florida, 33026
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Phoenix, Arizona, 85016
- Recruiting
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Pittsburgh, Pennsylvania, 15241
- Not yet recruiting
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Redondo Beach, California, 90277
- Withdrawn
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River Forest, Illinois, 60305
- Recruiting
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Riverside, California, 92506
- Completed
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Rochester, New York, 14607
- Completed
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Rock Hill, South Carolina, 29730
- Recruiting
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San Antonio, Texas, 78215
- Recruiting
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San Antonio, Texas, 78229
- Not yet recruiting
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San Antonio, Texas, 78249
- Recruiting
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San Diego, California, 92123
- Not yet recruiting
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San Diego, California, 92123
- Withdrawn
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San Francisco, California, 94143
- Recruiting
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Silver Spring, Maryland, 20902
- Recruiting
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Sioux Falls, South Dakota, 57105
- Recruiting
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Snellville, Georgia, 30078
- Recruiting
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St Louis, Missouri, 63108
- Withdrawn
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Tampa, Florida, 33613
- Recruiting
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The Bronx, New York, 10459
- Recruiting
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The Bronx, New York, 10461
- Recruiting
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Toledo, Ohio, 43617
- Completed
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Tyler, Texas, 75708
- Recruiting
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Vancouver, Washington, 98664
- Recruiting
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Vestal, New York, 13850
- Withdrawn
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Vestal, New York, 13850
- Recruiting
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Watertown, New York, 13601
- Recruiting
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West Jordan, Utah, 84088
- Recruiting
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Westminster, California, 92683
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White Marsh, Maryland, 21162
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Wilmington, Delaware, 19803
- Recruiting
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Yukon, Oklahoma, 73099
China22 sites, 22 recruiting
- Recruiting
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Beijing, 100050
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Beijing, 100191
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Bengbu, 233004
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Chengdu, 610066
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Chongqing, 401122
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Hohhot, 10050
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Mianyang, 621000
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Shanghai, 200062
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Shanghai, 200433
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Shanghai
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Shantou, 515041
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Shenyang, 110004
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Shenzhen, 518026
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Suzhou, 215002
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Taizhou, 318000
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Tianjin, 300050
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Tianjin, 300134
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Tianjin, 300211
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Wuhan, 430000
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Yanji, 133000
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Yantai, 264000
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Zhongshan, 528400
South Africa8 sites, 8 recruiting
- Recruiting
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Durban, 3630
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Durban, 4001
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Durban, 4092
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Krugersdorp, 1739
- Recruiting
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Middelburg, 1055
- Recruiting
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Panorama, 7500
- Not yet recruiting
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Somerset West, 7130
- Recruiting
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Welkom, 9460
Mexico5 sites, 5 recruiting
- Recruiting
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Chihuahua City, 31000
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Chihuahua City, 31238
- Recruiting
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Guadalajara, 44100
- Recruiting
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Guadalajara, 44500
- Recruiting
Research Site
Monterrey, 64465
About this study
Official title: 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)
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.
Read the detailed description
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks.
The study will consist of 3 periods:
- Screening period (7 to 28 days)
- Treatment period of 52 weeks
- Safety follow-up period (7 to 14 days after the end of treatment [EOT] visit)
Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period.
This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.
- Conditions
- Asthma
- Being tested
- BDA MDI, AS MDI
- Keywords
- Fast-acting β2-agonist, Metered-Dose Inhaler (MDI), Bronchodilatory, Inhaled corticosteroids, Anti-inflammatory, Rescue Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDA MDICombination product
Also called PT027
Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
AS MDICombination product
Also called PT007
Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide/albuterol metered -dose inhaler (BDA MDI) | Experimental | Participants will receive BDA MDI 160/180 μg (given as 2 puffs of 80/90 μg) as needed. Receives: Combination Product: BDA MDI |
| Albuterol sulfate metered-dose inhaler (AS MDI) | Active comparator | Participants will receive AS MDI 180 μg (given as 2 puffs of 90 μg) as needed. Receives: Combination Product: AS MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Randomization (Day 1) to Week 52 (EOT)
Secondary outcomes (12)
Time to first (TTF) severe asthma exacerbation
The effect of BDA MDI compared with AS MDI, both administered as needed, on the risk of a first severe asthma exacerbation in participants with asthma will be evaluated.
Measured: From Randomization (Day 1) to Week 52 (EOT)
Annualized total systemic corticosteroids (SCS) exposure for treatment of asthma
The effect of BDA MDI compared with AS MDI, both administered as needed, on the annualized total SCS exposure for treatment of asthma in participants with asthma will be evaluated.
Measured: From Randomization (Day 1) to Week 52 (EOT)
Number of participants with adverse events (AEs) and severe adverse events (SAEs)
The safety and tolerability of BDA MDI compared with AS MDI in participants with asthma will be assessed.
Measured: Up to Week 52
Maximum Observed Concentration (Cmax)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: 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)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: 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 infinity (AUCinf)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Time to reach maximum concentration following drug administration (Tmax)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Time of last quantifiable concentration (Tlast)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Terminal elimination half-life (t½λz)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Terminal elimination rate constant (λz)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Apparent total body clearance (CL/F)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Apparent volume of distribution based on the terminal phase (Vz/F)
The PK of budesonide and albuterol in participants with asthma, following a single dose of BDA MDI will be characterized.
Measured: At 0, 10, 20, 40 minutes and 1, 2, 4, 6, 8, 10, and 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start20 May 2024
- Primary completion13 Oct 2027 (estimated)
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307665
- Sponsor's protocol ID
- D6934C00001
- Acronym
- ACADIA
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41791845