Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
AstraZeneca · with Parexel · NCT06307665
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 440
- US sites recruiting
- 82
- Study start
- May 20, 2024
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: BDA MDI; AS MDI
Conditions: Asthma
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Recruiting US locations
Research Site
Anchorage, AK 99508
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Gilbert, AZ 85234
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Phoenix, AZ 85016
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Long Beach, CA 90806
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Long Beach, CA 90815
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Mission Viejo, CA 92691
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Moreno Valley, CA 92553
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Orange, CA 92868
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Riverside, CA 92506
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San Diego, CA 92123
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Westminster, CA 92683
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Denver, CO 80206
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Wilmington, DE 19803
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Destin, FL 32541
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Jacksonville, FL 32207
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Miami, FL 33142
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Miami, FL 33144
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Miami, FL 33145
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Miami, FL 33185
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Pembroke Pines, FL 33026
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Atlanta, GA 30329
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Columbus, GA 31904
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Fayetteville, GA 30214
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Snellville, GA 30078
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Normal, IL 61761
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Indianapolis, IN 46202
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Kansas City, KS 66160
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Louisville, KY 40202
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Louisville, KY 40217
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Lafayette, LA 70508
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New Orleans, LA 70121
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New Orleans, LA 70125
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Ellicott City, MD 21043
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Silver Spring, MD 20902
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White Marsh, MD 21162
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Detroit, MI 48201
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Kansas City, MO 64118
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St Louis, MO 63108
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Missoula, MT 59804
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Lincoln, NE 68510
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Lincoln, NE 68516
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Omaha, NE 68114
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Newark, NJ 07103
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Northfield, NJ 08225
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Ocean City, NJ 07712
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Paramus, NJ 07652
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Albuquerque, NM 87106
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Albany, NY 12208
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Cortland, NY 13045
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Hawthorne, NY 10532
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New York, NY 10032
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The Bronx, NY 10459
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The Bronx, NY 10461
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Vestal, NY 13850
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Watertown, NY 13601
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Columbus, OH 43228
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Dayton, OH 45424
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Findlay, OH 45840
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Toledo, OH 43617
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Oklahoma City, OK 73104
+ 22 more on the official record.
Study contacts (from the official record)
- AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com