AICS-Bud 1 mg | AICS-Bud 0.5 mg | AICS-placebo | CN-Bud 1 mg | |
Patients n | 80 | 39 | 40 | 40 |
Serum Bud# pg·mL−1 | ||||
Baseline¶ | 1671±1029 (n=71, Cv=62%) | 797±416 (n=36, Cv=52%) | 53±86 (n=8)# | 661±459 (n=35, Cv=69%) |
End of treatment+ | ||||
Pre-inhalation | 598±968 (n=64) | 233±572 (n=31) | 138±250 (n=11)# | 307±492 (n=28) |
30–60 min post-inhalation | 1875±1362 (n=70, Cv=73%) | 1110±661 (n=33, Cv=60%) | 158±241 (n=11)# | 832±711 (n=33, Cv=85%) |
Serum cortisol§ƒ nmol·L−1 | ||||
Baseline | 175±142 (n=75) | 166±141 (n=36) | 266±173 (n=37) | 187±189 (n=35) |
End of treatment+ | 174±131 (n=72) | 179±143 (n=38) | 255±173 (n=37) | 235±202 (n=37) |
UCCƒ## nmol·mmol−1 | ||||
Baseline | 7.7±7.2 (n=25) | 6.9±4.8 (n=9) | 9.3±11.2 (n=14) | 9.3±10.5 (n=10) |
End of treatment+ | 5.4±6.2 (n=22) | 5.4±6.7 (n=10) | 13.2±12.5 (n=12) | 5.4±4.8 (n=12) |
Data are presented as mean±sd unless otherwise stated. AICS: AKITA inhaled corticosteroid; Bud: budesonide; CN: conventional jet nebuliser; Cv: coefficient of variation; UCC: urine cortisol/creatinine. #: data for patients with levels below the lower level of quantification are not included in the table; ¶: 30–60 min post-inhalation; +: week 18; §: serum cortisol reference range 171–535 nmol·L−1; ƒ: mean values from samples obtained at 09:00 h; ##: measured only for patients in Germany and Poland.