RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2024-05-20
Study Completion:2027-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06307665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Confirmed clinical diagnosis of asthma at least 12 months.
  2. * Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month
  3. 1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)
  4. 2. 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
  5. * Receiving inhaled short-acting β2-agonist (SABA) as needed.
  6. * A documented history of at least one severe asthma exacerbation within 12 months.
  7. * Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.
  8. * Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.
  9. * Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.
  10. * Participants must adhere to protocol specific contraception methods.
  11. * Negative urine pregnancy test for participants of childbearing potential.
  12. * Have a BMI \< 40 kg/ m\^2.
  13. * 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.
  1. * 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).
  2. * Experienced \> 3 severe asthma exacerbations within 12 months before screening.
  3. * Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.
  4. * Upper respiratory infection involving antibiotic treatment not resolved.
  5. * 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).
  6. * Other significant lung disease, including regular or occasional use of oxygen.
  7. * Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.
  8. * Cancer not in complete remission for at least 5 years.
  9. * History or hospitalization for psychiatric disorder or attempted suicide within one year.
  10. * Significant abuse of alcohol or drugs, in the opinion of the investigator.
  11. * 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).
  12. * Use of any oral SABAs within one month.
  13. * Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Anchorage, Alaska, 99508
United States
Research Site
Gilbert, Arizona, 85234
United States
Research Site
Little Rock, Arkansas, 72202
United States
Research Site
Long Beach, California, 90806
United States
Research Site
Mission Viejo, California, 92691
United States
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Orange, California, 92868
United States
Research Site
Riverside, California, 92506
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Francisco, California, 94143
United States
Research Site
Westminster, California, 92683
United States
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Denver, Colorado, 80206
United States
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Wilmington, Delaware, 19803
United States
Research Site
Destin, Florida, 32541
United States
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Jacksonville, Florida, 32207
United States
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Miami, Florida, 33145
United States
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Seminole, Florida, 33777
United States
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Columbus, Georgia, 31904
United States
Research Site
Fayetteville, Georgia, 30214
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
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Kansas City, Kansas, 66160
United States
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Louisville, Kentucky, 40202
United States
Research Site
Lafayette, Louisiana, 70508
United States
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New Orleans, Louisiana, 70121
United States
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Silver Spring, Maryland, 20902
United States
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White Marsh, Maryland, 21162
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Detroit, Michigan, 48201
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Mankato, Minnesota, 56001
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Kansas City, Missouri, 64108
United States
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Missoula, Montana, 59804
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Lincoln, Nebraska, 68510
United States
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Omaha, Nebraska, 68114
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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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Albuquerque, New Mexico, 87106
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Albany, New York, 12208
United States
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Bronx, New York, 10459
United States
Research Site
Bronx, New York, 10461
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Cortland, New York, 13045
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Research Site
Hawthorne, New York, 10532
United States
Research Site
Hollis, New York, 11423
United States
Research Site
New York, New York, 10019
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Research Site
New York, New York, 10032
United States
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Rochester, New York, 14607
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Vestal, New York, 13850
United States
Research Site
Vestal, New York, 13850
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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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Dayton, Ohio, 45424
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
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Yukon, Oklahoma, 73099
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Pittsburgh, Pennsylvania, 15241
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Charleston, South Carolina, 29425
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Rock Hill, South Carolina, 29730
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Sioux Falls, South Dakota, 57105
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Nashville, Tennessee, 37232
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Austin, Texas, 78759
United States
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Baytown, Texas, 77521
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Research Site
Beaumont, Texas, 77701
United States
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Corsicana, Texas, 75110
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Dallas, Texas, 75231
United States
Research Site
Frisco, Texas, 75034
United States
Research Site
Houston, Texas, 77065
United States
Research Site
Houston, Texas, 77099
United States
Research Site
Kerrville, Texas, 78028
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
San Antonio, Texas, 78215
United States
Research Site
San Antonio, Texas, 78229
United States
Research Site
Tyler, Texas, 75708
United States
Research Site
West Jordan, Utah, 84088
United States
Research Site
Burlington, Vermont, 05405
United States
Research Site
Burke, Virginia, 22015
United States
Research Site
Bellingham, Washington, 98225
United States
Research Site
Vancouver, Washington, 98664
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20
Study Completion Date2027-10-13

Study Record Updates

Study Start Date2024-05-20
Study Completion Date2027-10-13

Terms related to this study

Keywords Provided by Researchers

  • Fast-acting β2-agonist
  • Metered-Dose Inhaler (MDI)
  • Bronchodilatory
  • Inhaled corticosteroids
  • Anti-inflammatory
  • Rescue Therapy

Additional Relevant MeSH Terms

  • Asthma