fluticasone-propionate--salmeterol-xinafoate-drug-combination and ciclesonide

Recommended treatment for moderate to severe asthma is the combination of an inhaled corticosteroid and a long-acting beta2-agonist. The present study was designed to evaluate the efficacy of a newly developed fixed combination of ciclesonide and formoterol in comparison to the marketed fixed combination of fluticasone and salmeterol in patients with moderate asthma. This was a phase II, multi-centre, randomized, parallel-group, double-blind, double-dummy study. After a 2-week run-in period, 160 patients with moderate asthma were randomized to a 6-week treatment with ciclesonide/formoterol 320/9 μg bid (CIC/F) or fluticasone propionate/salmeterol 250/50 μg bid (FP/S), both delivered as powder formulations. The primary outcome FEV1 increased during treatment by 0.356 L in the CIC/F group and by 0.288 L in the FP/S group (p < 0.0001). The increases were statistically significant and clinically relevant. The between-treatment analysis demonstrated non-inferiority of CIC/F to FP/S treatment (p < 0.0001). A significant improvement from baseline in lung function, symptom score and rescue medication use was observed in both groups at all time points. No differences were observed between treatments in the frequency of adverse events and overnight urinary cortisol/creatinine ratio. The studied fixed combination of ciclesonide/formoterol is not inferior to the marketed fixed combination of fluticasone/salmeterol in terms of efficacy and tolerability.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Albuterol; Androstadienes; Anti-Asthmatic Agents; Asthma; Austria; Bronchodilator Agents; Child; Double-Blind Method; Drug Combinations; Ethanolamines; Female; Fluticasone-Salmeterol Drug Combination; Forced Expiratory Volume; Formoterol Fumarate; Germany; Glucocorticoids; Humans; Male; Middle Aged; Pregnenediones; Treatment Outcome; Young Adult

Intranasal and inhaled corticosteroid administration concurrently in comorbid allergic rhinitis (AR) and asthma may potentially enhance cortisol suppression. This study determined whether intranasal ciclesonide 200 micro g once daily has an additional effect on cortisol suppression when coadministered with inhaled fluticasone propionate-salmeterol (FP-SAL) 500 to 50 micro g twice daily. Adults (N = 150) with perennial AR received FP-SAL and placebo nasal spray during the run-in period. Patients were randomized to ciclesonide or placebo and FP-SAL (43 days). A single 2-mg dose of dexamethasone was administered on the last treatment day. Plasma cortisol decreased during run-in period (p < 0.001), indicating cortisol suppression by FP-SAL. After ciclesonide was added to FP-SAL, plasma cortisol was similar in both groups. Dexamethasone decreased mean plasma cortisol (p < 0.001), demonstrating that further suppression was possible. Ciclesonide coadministered with FP-SAL did not have an additive effect on cortisol suppression compared with FP-SAL.

Topics: Administration, Inhalation; Administration, Intranasal; Adolescent; Adult; Albuterol; Androstadienes; Anti-Allergic Agents; Bronchodilator Agents; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Fluticasone-Salmeterol Drug Combination; Humans; Hydrocortisone; Male; Middle Aged; Pregnenediones; Rhinitis, Allergic, Perennial