Effects of mometasone furoate dry powder inhaler and beclomethasone dipropionate hydrofluoroalkane and chlorofluorocarbon on the hypothalamic-pituitary-adrenal axis in asthmatic subjects.
OBJECTIVE
Mometasone furoate dry powder inhaler (MF-DPI) [400 mug] is an inhaled corticosteroid (ICS) that is effective in the treatment of asthma. MF-DPI has a low potential for suppression of the hypothalamic-pituitary-adrenal (HPA) axis at its clinical dose. The effect of MF-DPI, 400 microg qd, on the HPA axis was compared to that of beclomethasone dipropionate (BDP) using hydrofluoroalkane (HFA) and chlorofluorocarbon (CFC) propellants via metered-dose inhalers (MDIs) twice daily.


METHODS
This randomized, third-party blind, parallel-group study compared the effects of MF-DPI 400 mug one puff qd in the morning (n = 18), HFA-BDP 200 microg two puffs MDI bid (n = 18), and CFC-BDP 400 microg two puffs MDI bid (n = 17) for 14 days on the area under the 24-h serum cortisol concentrations curve (AUC(0-24)) and on total 24-h urinary free cortisol excretion in mild asthmatic subjects. Effects on morning/evening peak expiratory flow (PEF) and on inhaled albuterol use were also assessed. Adverse events that occurred during or > or = 30 days after the study were recorded.


RESULTS
The mean decrease from baseline in the serum cortisol concentrations AUC(0-24) in the MF-DPI group was significantly less than in either the HFA-BDP (p = 0.024) or the CFC-BDP (p = 0.011) groups. Decreases in serum cortisol concentrations AUC(0-24) in the two BDP groups did not differ from one another. The MF-DPI group trended toward higher morning and evening PEF than either BDP group. Treatment-associated adverse events were reported by seven subjects in the MF-DPI group, vs one subject in the HFA-BDP and three subjects in the CFC-BDP groups; these were mild, and no subject discontinued treatment due to an adverse event.


CONCLUSIONS
Fourteen days of treatment with MF-DPI 400 microg qd was associated with a significantly lesser decrease in the serum cortisol concentrations AUC(0-24) compared with HFA-BDP 200 microg MDI or CFC-BDP 400 microg MDI bid.
First Department of Pediatrics, Athens University Medical School, Agia Sophia Children's Hospital, 11527 Athens, Greece. chrousge@med.uoa.gr
George P
GP
Chrousos
Lisa
L
Ghaly
Arthur
A
Shedden
Domenic G
DG
Iezzoni
Alan G
AG
Harris
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants / Q000008:administration & dosage / Q000494:pharmacology*; D000368:Aged; D000704:Analysis of Variance; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000494:pharmacology*; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000494:pharmacology*; D017402:Chlorofluorocarbons / Q000008:administration & dosage / Q000494:pharmacology*; D003404:Creatinine / Q000652:urine; D005260:Female; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage / Q000494:pharmacology; D006854:Hydrocortisone / Q000097:blood; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D011244:Pregnadienediols / Q000008:administration & dosage / Q000494:pharmacology*
D000335:Aerosol Propellants; D018927:Anti-Asthmatic Agents; D000893:Anti-Inflammatory Agents; D017402:Chlorofluorocarbons; D006845:Hydrocarbons, Fluorinated; D011244:Pregnadienediols; D000068656:Mometasone Furoate; D003404:Creatinine; D001507:Beclomethasone; D006854:Hydrocortisone