RECRUITING

A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant (HFO) Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma

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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 assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Official Title

A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma

Quick Facts

Study Start:2024-07-22
Study Completion:2026-02-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06502366

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be ≥ 18 years of age at the time of signing the ICF.
  2. * Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1.
  3. * Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.
  4. * Participants with a pre-bronchodilator FEV1 of ≥ 60% and \< 90% predicted normal at Visit 1 or Visit 1a.
  5. * Participants with a pre-dose FEV1 of ≥ 60% and \< 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.
  6. * Participants who demonstrate bronchodilator responsiveness defined as a \> 12% and \> 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a.
  7. * Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update
  8. * Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
  9. * Participants with a body mass index \< 40 kg/m2.
  10. * Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control
  1. * Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease.
  2. * Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1.
  3. * An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1.
  4. * A lower respiratory infection in the 4 weeks prior to Visit 1.
  5. * Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1.
  6. * Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1.
  7. * A severe asthma exacerbation during the run-in period
  8. * An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms
  9. * Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study.
  10. * Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1
  11. * Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.
  12. * Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Mobile, Alabama, 36608
United States
Research Site
Sheffield, Alabama, 35660
United States
Research Site
Phoenix, Arizona, 85018
United States
Research Site
Little Rock, Arkansas, 72205
United States
Research Site
Banning, California, 92220
United States
Research Site
Encinitas, California, 92024
United States
Research Site
Fullerton, California, 92835
United States
Research Site
Gardena, California, 90247
United States
Research Site
Huntington Beach, California, 92647
United States
Research Site
La Mesa, California, 91942
United States
Research Site
Los Angeles, California, 90025
United States
Research Site
Los Angeles, California, 90048
United States
Research Site
Panorama City, California, 91402
United States
Research Site
Sacramento, California, 95821
United States
Research Site
San Diego, California, 92123
United States
Research Site
San Jose, California, 95117
United States
Research Site
Santa Ana, California, 92704
United States
Research Site
Stockton, California, 95207
United States
Research Site
Westminster, California, 92683
United States
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Englewood, Colorado, 80110
United States
Research Site
Wheat Ridge, Colorado, 80033
United States
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Washington, District of Columbia, 20016
United States
Research Site
Boynton Beach, Florida, 33435
United States
Research Site
Tallahassee, Florida, 32308
United States
Research Site
Atlanta, Georgia, 30328
United States
Research Site
Rincon, Georgia, 31326
United States
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Savannah, Georgia, 31406
United States
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Boise, Idaho, 83706
United States
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Meridian, Idaho, 83646
United States
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River Forest, Illinois, 60305
United States
Research Site
Evansville, Indiana, 47715
United States
Research Site
Valparaiso, Indiana, 46383
United States
Research Site
Sioux City, Iowa, 51106
United States
Research Site
Lexington, Kentucky, 40509
United States
Research Site
Louisville, Kentucky, 40217
United States
Research Site
Lafayette, Louisiana, 70508
United States
Research Site
Metairie, Louisiana, 70006
United States
Research Site
White Marsh, Maryland, 21162
United States
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Flint, Michigan, 48504
United States
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Columbia, Missouri, 65203
United States
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Saint Louis, Missouri, 63141
United States
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Omaha, Nebraska, 68134
United States
Research Site
Middletown, New York, 10940
United States
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New York, New York, 10036
United States
Research Site
Watertown, New York, 13601
United States
Research Site
Charlotte, North Carolina, 28273
United States
Research Site
Raleigh, North Carolina, 27607
United States
Research Site
Cincinnati, Ohio, 45236
United States
Research Site
Medford, Oregon, 97504
United States
Research Site
Portland, Oregon, 97202
United States
Research Site
DuBois, Pennsylvania, 15801
United States
Research Site
Pottstown, Pennsylvania, 19464
United States
Research Site
Scottdale, Pennsylvania, 15683
United States
Research Site
Charleston, South Carolina, 29414
United States
Research Site
Greenville, South Carolina, 29615
United States
Research Site
North Charleston, South Carolina, 29420
United States
Research Site
Spartanburg, South Carolina, 29303
United States
Research Site
Boerne, Texas, 78006
United States
Research Site
Dallas, Texas, 75231
United States
Research Site
Dallas, Texas, 75231
United States
Research Site
DeSoto, Texas, 75115
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
San Antonio, Texas, 78258
United States
Research Site
Victoria, Texas, 77901
United States
Research Site
West Jordan, Utah, 84088
United States
Research Site
Burke, Virginia, 22015
United States
Research Site
Portsmouth, Virginia, 23703
United States
Research Site
Spokane, Washington, 99218
United States
Research Site
Morgantown, West Virginia, 26505
United States
Research Site
Milwaukee, Wisconsin, 53228
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 Date2024-07-22
Study Completion Date2026-02-24

Study Record Updates

Study Start Date2024-07-22
Study Completion Date2026-02-24

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma