Study objectives: Mometasone furoate dry powder inhaler (MF-DPI) [400 μg] 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 μg 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.
Design and interventions: This randomized, third-party blind, parallel-group study compared the effects of MF-DPI 400 μg one puff qd in the morning (n = 18), HFA-BDP 200 μg two puffs MDI bid (n = 18), and CFC-BDP 400 μg two puffs MDI bid (n = 17) for 14 days on the area under the 24-h serum cortisol concentrations curve (AUC0–24) 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 ≥ 30 days after the study were recorded.
Results: The mean decrease from baseline in the serum cortisol concentrations AUC0–24 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 AUC0–24 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 μg qd was associated with a significantly lesser decrease in the serum cortisol concentrations AUC0–24 compared with HFA-BDP 200 μg MDI or CFC-BDP 400 μg MDI bid.