Pharmacokinetics and clinical chemistry

AICS-Bud 1 mgAICS-Bud 0.5 mgAICS-placeboCN-Bud 1 mg
Patients n80394040
Serum Bud# pg·mL−1
 Baseline1671±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-inhalation598±968 (n=64)233±572 (n=31)138±250 (n=11)#307±492 (n=28)
  30–60 min post-inhalation1875±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
 Baseline175±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
 Baseline7.7±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.