Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02066129

Run by

Milton S. Hershey Medical Center

People needed

254

Starts

2014-07-01

Expected to finish

2017-04-21

Last updated by the study team

2018-07-11

Who can join

Age: 5 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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