Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
STICS
1 other identifier
interventional
254
1 country
18
Brief Summary
The objective of this study is to determine whether, in children receiving low-dose inhaled corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations reduces the rate of severe asthma exacerbations treated with oral corticosteroids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Jul 2014
Typical duration for phase_3 asthma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2017
CompletedResults Posted
Study results publicly available
July 11, 2018
CompletedJuly 11, 2018
June 1, 2018
2.8 years
February 17, 2014
April 23, 2018
June 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Exacerbations
The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.
end of 48 week treatment period
Secondary Outcomes (4)
Yellow Zone Asthma Symptoms
end of 48 week treatment period
Yellow Zone Albuterol Use
end of 48 week treatment period
Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma
end of 48 week treatment period
Number of Participants Hospitalized for Asthma
end of 48 week treatment period
Study Arms (2)
Fluticasone 44 mcg
ACTIVE COMPARATORFluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
Fluticasone 220 mcg
ACTIVE COMPARATORFluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
Interventions
Fluticasone is an inhaled corticosteroid
Fluticasone is an inhaled corticosteroid
Eligibility Criteria
You may qualify if:
- Physician-diagnosed asthma
- 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
You may not qualify if:
- Systemic (oral or injectable) corticosteroids within previous 2-week period
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Arizona College of Medicine
Tucson, Arizona, 85724, United States
Children's Hospital & Research Center Oakland
Oakland, California, 94609, United States
UCSF Benioff Children's Hospital
San Francisco, California, 94143, United States
National Jewish Health
Denver, Colorado, 80206, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Nemours Children's Clinic
Orlando, Florida, 32827, United States
Emory University
Atlanta, Georgia, 30322, United States
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, 44106, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
University of Wisconsin
Madison, Wisconsin, 53972, United States
Related Publications (3)
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.
PMID: 39510322DERIVEDYuan 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.
PMID: 37003356DERIVEDJackson 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.
PMID: 29504498DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Mauger, PhD
- Organization
- Penn State University Dept of Public Health Sciences
Study Officials
- STUDY CHAIR
William Busse, MD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, AsthmaNet Data Coordinating Center
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
July 1, 2014
Primary Completion
April 21, 2017
Study Completion
April 21, 2017
Last Updated
July 11, 2018
Results First Posted
July 11, 2018
Record last verified: 2018-06