Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Last updated: March 30, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Asthma

Treatment

AS MDI

BDA MDI

Clinical Study ID

NCT06307665
D6934C00001
  • Ages 12-17
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Confirmed clinical diagnosis of asthma at least 12 months.

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

  1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)

  2. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without oneadditional maintenance therapy from the following: leukotriene receptorantagonist (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) measurementsas 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 whichincludes compliance with the requirements and restrictions. The caregiver of thepatient must be capable of giving written informed consent for the patient'sparticipation in the study. Consent and assent forms must be completed prior to anystudy-specific procedures.

Exclusion

Exclusion Criteria:

  • Life-threatening asthma defined as any history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest, hypoxicseizures, 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 exacerbationwith 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 whostopped 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, butnot 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 oneyear.

  • 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 weeksbefore 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 budesonideand/or their excipients.

Study Design

Total Participants: 440
Treatment Group(s): 2
Primary Treatment: AS MDI
Phase: 3
Study Start date:
May 20, 2024
Estimated Completion Date:
October 13, 2027

Study 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:

  1. Screening period (7 to 28 days)

  2. Treatment period of 52 weeks

  3. 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.

Connect with a study center

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    Beijing, 100191
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    Beijing 1816670, 100050
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    Bengbu, 233004
    China

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    Bengbu 1816440, 233004
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    Chengdu, 610066
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    Chengdu 1815286, 610066
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    Chongqing, 401122
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    Chongqing 1814906, 401122
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    Hohhot, 10050
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    Hohhot 2036892, 10050
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    Mianyang, 621000
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    Mianyang 1800627, 621000
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    Shanghai, 200433
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    Shanghai 1796236, 200433
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    Shantou, 515041
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    Shenyang, 110004
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    Shenyang 2034937, 110004
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    Shenzhen, 518026
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    Shenzhen 1795565, 518026
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    Suzhou, 215002
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    Suzhou 1886760, 215002
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    Taizhou, 318000
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    Taizhou 1793505, 318000
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    Tianjin, 300211
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    Tianjin 1792947, 300050
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    Wuhan, 430000
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    Wuhan 1791247, 430000
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    Yanji, 133000
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    Yanji 2033467, 133000
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    Yantai, 264000
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    Yantai 1787093, 264000
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    Zhongshan, 528400
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    Zhongshan 6986104, 528400
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    Chihuahua, 31238
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    Chihuahua City, 31000
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    Chihuahua City 4014338, 31000
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    Guadalajara, 44500
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    Guadalajara 4005539, 44100
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    Monterrey, 64465
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    Monterrey 3995465, 64465
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    Durban, 4092
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    Durban 1007311, 3630
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    Krugersdorp, 1739
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    Krugersdorp 986822, 1739
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    Middelburg, 1055
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    Middelburg 976361, 1055
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    Panorama, 7500
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    Panorama 966305, 7500
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    Somerset West, 7130
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    Somerset West 6951112, 7130
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    Welkom, 9460
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    Welkom 940909, 9460
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    Anchorage, Alaska 99508
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    Normal, Illinois 61761
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    Normal 4903780, Illinois 4896861 61761
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    Kansas City 4393217, Missouri 4398678 64108
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    Missoula, Montana 59804
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    Missoula 5666639, Montana 5667009 59804
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    Omaha, Nebraska 68114
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    Lincoln 5072006, Nebraska 5073708 68510
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    Omaha 5074472, Nebraska 5073708 68114
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    Northfield, New Jersey 08225
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    Ocean City, New Jersey 07712
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    Paramus, New Jersey 07652
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    Newark 5101798, New Jersey 5101760 07103
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    Northfield 4503316, New Jersey 5101760 08225
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    Ocean City 4503351, New Jersey 5101760 07712
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    Paramus 5102387, New Jersey 5101760 07652
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    Albuquerque, New Mexico 87106
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    Albuquerque 5454711, New Mexico 5481136 87106
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    The Bronx, New York 10459
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    Albany 5106834, New York 5128638 12208
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    Hawthorne 5120284, New York 5128638 10532
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    Charlotte, North Carolina 28277
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    Charlotte 4460243, North Carolina 4482348 28277
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    Cincinnati, Ohio 45229
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    Rock Hill, South Carolina 29730
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    Austin, Texas 78759
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    Beaumont, Texas 77701
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    Corsicana, Texas 75110
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    Dallas, Texas 75231
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    McKinney, Texas 75069
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    San Antonio, Texas 78229
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    Tyler, Texas 75708
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    Austin 4671654, Texas 4736286 78759
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    Baytown 4672731, Texas 4736286 77521
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    Beaumont 4672989, Texas 4736286 77701
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    Bellaire 4673353, Texas 4736286 77401
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    Dallas 4684888, Texas 4736286 75231
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    Houston 4699066, Texas 4736286 77065
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    Kerrville 4703078, Texas 4736286 78028
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    McKinney 4710178, Texas 4736286 75069
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    San Antonio 4726206, Texas 4736286 78215
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    Tyler 4738214, Texas 4736286 75708
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    West Jordan, Utah 84088
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    West Jordan 5784549, Utah 5549030 84088
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    Burlington, Vermont 05405
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    Burlington 5234372, Vermont 5242283 05405
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    Burke, Virginia 22015
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    Burke 4749950, Virginia 6254928 22015
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    Bellingham, Washington 98225
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    Vancouver, Washington 98664
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    Vancouver 5814616, Washington 5815135 98664
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