Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma: Methods

Ciclesonide Reduces the Need for Oral Steroid Use in Adult Patients With Severe, Persistent Asthma: MethodsPrior to randomization, during the screening period, the lowest effective dose of oral prednisone was established for each patient. This was determined in one of two ways: (1) a documented history verifying failed attempts at prednisone dose reduction within 2 months prior to screening/baseline; such patients were considered to be currently on their lowest effective dose; (2) alternatively, if documentation was not available, patients were instructed to reduce their prednisone dose during screening, at weekly intervals in predefined steps until one of the following criteria was not met: FEV1 > 80% of the actual value at the screening visit (week 1; for safety reasons, not < 40% of the predicted normal value) or no increase in 24-h asthma symptoms, nighttime awakenings, or albuterol use. Patients who failed one or more of these criteria were returned to a dose one step higher, which was considered the lowest effective dose for that patient. Patients who did not deteriorate on doses < 5 mg/d did not qualify for inclusion and were withdrawn. All five criteria listed in Table 2 had to be met in order for prednisone dose reduction to occur. The dose reduction schedule is shown in Table 3. other
When dose reduction criteria were not met, the investigator either maintained the current dose of prednisone or stepped up the dose if the symptoms had increased (Table 4). When symptoms merited a greater increase, the prednisone dose was increased by up to 10 mg qd or 20 mg every other day at the investigators’ discretion. Severe increases in symptoms were treated with a prednisone burst (40 to 60 mg tapered over a 7- to 10-day period to a dose of 2.5 mg above the preburst dose for once-daily regimens or 5 mg above the preburst dose for every other day regimens). If patients required a second prednisone burst, they were discontinued from the study. Patients remaining in the study continued at their lowest effective OCS dose for at least 7 days before randomization, with albuterol hydrofluoroal-kane-metered dose inhaler (HFA-MDI) canisters (Schering/Key Pharmaceuticals; Kenilworth, NJ) provided as rescue medication.

Table 2—Eligibility Criteria for Prednisone Dose Reduction at Weekly Visits Throughout the 12-Week Study Period

Criteria Definition
1 FEVj a 80% of baseline FEVj and a 40% of predicted FEVj values
2 Morning PEF a 80% of baseline mean morning PEF on all days since last visit*
3 Mean nighttime awakenings s 50% increase over the baseline period (per night), s 150% of the baseline mean
4 Albuterol use for any 2 consecutive days since the last visit, not more than 4 puffs/d above the mean baseline value or 12 puffs/d
5 No prednisone burst required since the previous visit

Table 3—Prednisone Dose Reduction Schedule During the Double-Blind Treatment Period

Prednisone Dosing Present Dose of Prednisone, mg Prednisone Dose Reduction, mg
Daily regimen 12.5-30 5
7.5-10 2.5
s 5 1.25
Every-other-day regimen 25-60 10
15-20 5
s 10 5-7.5 2.5
s 3.75 1.25
Every-other-day regimen a 20 10
10-15 5
s 7.5 2.5

Table 4—Prednisone Dose Escalation Schedule During the Double-Blind Treatment Period

Prednisone Dosing Present Dose of Prednisone, mg Prednisone Dose Increase, mg
Daily regimen a 10 5

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