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

Taken together, these data suggest that ciclesonide, with its favorable therapeutic profile, may be a suitable OCS-sparing therapy.
We report here the results of a placebo-controlled study examining the efficacy of ciclesonide administered twice daily in reducing the use of the OCS prednisone in patients with severe, persistent asthma. The effects on HPA-axis function and pulmonary function were also assessed.
Male and female patients aged > 12 years with OCS-depen-dent, severe, persistent asthma (according to the Global Initiative for Asthma guidelines) diagnosed at least 12 months prior to screening were enrolled in a 12-week, international, randomized, double-blind, placebo-controlled, parallel-group study. Patients were required to have received oral prednisone daily or on alternate days for at least 5 of the previous 6 months (5 to 30 mg/d and/or 10 to 60 mg every other day) and to have received ICS therapy continuously during the previous 6 months, with inhaled P2-agonists used as rescue medication for at least the preceding 2 weeks. Patients were instructed to use their currently prescribed ICS at the recommended fixed maintenance doses during the screening period (1 to 4 weeks) until the day before randomization (Table 1). Patients were required to be nonsmokers or ex-smokers with a < 10 pack-per-year cigarette smoking history who had not smoked for at least 6 months.
Patients with a history of life-threatening asthma episodes within the last 2 years or who required a burst of prednisone during screening due to an asthma exacerbation were excluded from the study. Additional therapy permitted during the study period included previously prescribed intranasal glucocorticoids (for rhinitis), cromolyn sodium, antihistamines, and hydrocortisone cream or ointment < 1%, all at a stable dose. Montelukast, theophylline, anticholinergics, oral p2-agonists, long-acting bron-chodilators, and short-acting or nebulized P2-agonists were also permitted; however, they had to be withheld for specified time periods before the clinic visits for lung function testing. Eligible patients had to demonstrate a FEV1 of 40 to 80% of predicted normal values following the withholding of p2-agonists for 6 h and a > 12% reversibility in FEV1 following inhaled medication (with an absolute volume increase of > 200 mL), either at screening/baseline or randomization, or a documented history of these pulmonary function requirements within the previous 12 months.

Table 1—ICS Use During the Screening Period (1 to 4 Weeks Prior to Randomization) in the ITT Population

Corticosteroid Placebo (n = 45) CIC640 (n = 47) CIC1280 (n = 48)
Budesonide, ^g/d 1,000.0 (392.8) 1,070.0(441.4) 944.4 (334.7)
No. (%) 15 (33.3) 20 (42.6) 18 (37.5)
Fluticasone, ^g/d 878.5 (218.9) 844.7(351.8) 1,048.6 (452.3)
No. (%) 13 (28.9) 17 (36.2) 14 (29.2)
Fluticasone/salmeterol, ^g/d 833.3 (246.2) 1,055.6 (583.3) 941.2 (166.1)
No. (%) 12 (26.7) 9(19.1) 17 (35.4)
Triamcinolone, ^g/d 1,600.0 (NA) 1,200.0 (NA) 900.0 (NA)
No. (%) 1 (2.2) 1(2.1) 1(2.1)
Beclomethasone, ^g/d 766.7(321.5) 200.0 (NA)
No. (%) 3(6.7) 1(2.1) 0 (0.0)
Beclomethasone hydrofluoroalkane, ^g/d 640.0 (NA)
No. (%) 1 (2.2) 0 (0.0) 0 (0.0)
Flunisolide, ^g/d 3,000.0 (NA)
No. (%) 1 (2.2) 0 (0.0) 0 (0.0)

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