Effects of mometasone furoate dry powder inhaler and beclomethasone dipropionate hydrofluoroalkane and chlorofluorocarbon on the hypothalamic-pituitary-adrenal axis in asthmatic subjects

Study objectives: Mometasone furoate dry powder inhaler (MF-DPI) [400 mu g] is an inhaled corticosteroid (ICS) that is effective in the treatment of asthma. MF-DPl has a low potential for suppression of the hypothalamic-pituitary-adrenal (HPA) axis at its clinical dose. The effect of MF-DPI, 400 mu g qd, on the UPA axis was compared to that of beclomethasone dipropionate (BDP) using hydrofluoroalkane, (HFA) and chlorofluorocarbon (CFC) propellants via metered-dose inhalers (MDIs) twice daily. Design and interventions: This randomized, third-party blind, parallel-group study compared the effects of MF-DPl 400 mu g one puff qd in the morning (n 18), HFA-BDP 200 mu g two puffs MDI bid (n = 18), and CFC-BDP 400 mu g 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 How (PEF) and on inhaled albuterol use were also assessed. Adverse events that occurred during 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-DP1 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-DP1 400 mu g qd was associated with a significantly lesser decrease in the serum cortisol concentrations AUC(0-24) compared With HFA-BDP 200 mu g MDI or CFC-BDP 400 mu g MDI bid.