Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS)

Penn State Health

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Fluticasone 220 mcg

Drug: Fluticasone 44 mcg

Study type

Interventional

Funder types

Other

Identifiers

NCT02066129

AsthmaNet 008

Details and patient eligibility

About

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.

Full description

The study design is a double-blind, parallel-group trial, including a total of 250 participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma exacerbation treated with oral corticosteroids in the prior year. All participants will be treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the 48-week treatment period, participants will receive randomized blinded therapy for 7 days each time they enter the "yellow zone" (at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be fluticasone 44 or 220 mcg 2 puffs twice daily.

Enrollment

254 patients

Sex

All

Ages

5 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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