Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
NCT ID: NCT02066129
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
254 participants
INTERVENTIONAL
2014-07-31
2017-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fluticasone 44 mcg
Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
Fluticasone 44 mcg
Fluticasone is an inhaled corticosteroid
Fluticasone 220 mcg
Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
Fluticasone 220 mcg
Fluticasone is an inhaled corticosteroid
Interventions
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Fluticasone 44 mcg
Fluticasone is an inhaled corticosteroid
Fluticasone 220 mcg
Fluticasone is an inhaled corticosteroid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in the past 12 months
* Able to perform reproducible spirometry
* Current treatment with step 2 controller therapy \[low-dose ICS, leukotriene receptor antagonist (LTRA)\] OR current treatment with step 3 controller therapy \[low-dose ICS + long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS\] with a childhood Asthma Control Test (c-ACT) score of \>19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1 second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy \[asthma symptoms or short acting beta agonist (SABA) use \> 2 days per week or night-time awakenings due to asthma \> 2 nights per month\]
* Prebronchodilator FEV1 ≥ 60% predicted
* Ability and willingness to provide informed assent
* For females of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method.
* History of clinical varicella or varicella vaccine
Exclusion Criteria
* Current or recent (previous 2-weeks) use of medications known to significantly interact with corticosteroid disposition, including but not limited to carbamazepine, erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole
* Presence of chronic or active lung disease other than asthma
* Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study
* A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
* History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure
* More than 5 prednisone treated exacerbations in the past 12 months
* More than 1 hospitalizations lasting \>24 hours for asthma in the past 12 months
* History of adverse reactions to ICS preparations or any of their ingredients
* Receiving hyposensitization therapy other than an established maintenance regimen (On maintenance regimen for ≥ 3 months)
* History of premature birth before 35 weeks gestation
5 Years
11 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Principal Investigators
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William Busse, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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University of Arizona College of Medicine
Tucson, Arizona, United States
Children's Hospital & Research Center Oakland
Oakland, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
Children's Hospital Boston
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Gomez LF, Kinnee E, Kaufman JD, Young MT, Fitzpatrick AM, Phipatanakul W, Mauger DT, McClure LA, Bilal U, Holguin F, Clougherty JE. Modification of asthma treatment efficacy by healthcare access: A reanalysis of AsthmaNet Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) clinical trial. Respir Med. 2024 Nov-Dec;234:107853. doi: 10.1016/j.rmed.2024.107853. Epub 2024 Nov 5.
Yuan H, Liu Z, Dong J, Bacharier LB, Jackson D, Mauger D, Boushey H, Castro M, Durack J, Huang YJ, Lemanske RF Jr, Storch GA, Weinstock GM, Wylie K, Covar R, Fitzpatrick AM, Phipatanakul W, Robison RG, Beigelman A, Zhou Y. The Fungal Microbiome of the Upper Airway Is Associated With Future Loss of Asthma Control and Exacerbation Among Children With Asthma. Chest. 2023 Aug;164(2):302-313. doi: 10.1016/j.chest.2023.03.034. Epub 2023 Mar 30.
Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, Fitzpatrick AM, Gaffin JM, Morgan WJ, Peters SP, Phipatanakul W, Sheehan WJ, Cabana MD, Holguin F, Martinez FD, Pongracic JA, Baxi SN, Benson M, Blake K, Covar R, Gentile DA, Israel E, Krishnan JA, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Long D, Ly N, Marbin J, Moy JN, Myers RE, Olin JT, Raissy HH, Robison RG, Ross K, Sorkness CA, Lemanske RF Jr; National Heart, Lung, and Blood Institute AsthmaNet. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891-901. doi: 10.1056/NEJMoa1710988. Epub 2018 Mar 3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AsthmaNet
Other Identifiers
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AsthmaNet 008
Identifier Type: -
Identifier Source: org_study_id
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