Clinical trial NCT02066129 (phase 3, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: fluticasone 44 mcg, fluticasone 220 mcg
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C, [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
Eligibility criteria:

        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