Dose-ranging study of a new steroid for asthma: mometasone furoate dry powder inhaler

Abstract

A new formulation of mometasone furoate (MF) for administration by dry powder inhaler (DPI) was evaluated for the treatment of asthma. A 12-week, double-blind, placebo-controlled dose-ranging study compared the efficacy and safety of three doses of MF DPI (100, 200 and 400 mcg b.i.d) with beclomethasone dipropionate (BDP) 168 mcg b.i.d. administered by metered dose inhaler in 365 adult or adolescent patients being treated with inhaled glucocorticoids. The mean change from baseline to endpoint (last treatment visit) for forced expiratory volume in 1 sec (FEV1) was the primary efficacy variable. Secondary efficacy variables included other objective measures of pulmonary function [forced vital capacity (FVC), forced expiratory flow 25-75% (FEV25-75%.) and peak expiratory flow rate (PEFR)] as well as subjective measures of therapeutic response (patients' daily evaluation of asthma symptoms and physicians' evaluation). At endpoint, all four active treatments were significantly more effective than placebo (P < 0.01) in improving FEV1 (MF DPI 5 to 7%, BDP 3%, placebo -6.6%) and all other measures of pulmonary function (FVC: MF DPI 4 to 5%, BDP 2%, placebo -4.7%; FEF25-75%: MF DPI 6 to 18%, BDP 7.5%, placebo -9.5%; PEFR (AM): MF DPI 5 to 10%, BDP 5.7%, placebo -7%). A consistent trend was observed for better improvement in patients treated with MF DPI 200 mcg b.i.d. than with MF DPI 100 mcg b.i.d., with no apparent additional benefit of MF DPI 400 mcg b.i.d. Results for the MF DPI 100 mcg b.i.d. and BDP 168 mcg b.i.d. treatment groups were similar. Patients' and physicians' subjective evaluations of symptoms found similar improvement in the MF DPI 200 and 400 mcg b.i.d. treatment groups, which were slightly better than that in the MF DPI 100 mcg b.i.d. group. Symptoms tended to worsen in the placebo group. MF DPI was well tolerated at all dose levels and the most frequently reported treatment-related adverse effects were headache, pharyngitis and oral candidiasis. No evidence of HPA-axis suppression was detected in any treatment group. In summary, all doses of MF DPI were well tolerated and significantly improved lung function and MF DPI 400 mcg (200 mcg b.i.d.) was the optimal dose in this study of patients with moderate persistent asthma.

Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function

“…Mometasone furoate (MF), a potent ICS with high affinity for the glucocorticoid receptor and low bioavailability, improves lung function, decreases asthma symptoms and reduces the frequency and severity of asthma deteriorations at daily doses of 100-800 mg [10][11][12]. Formoterol (F), a LABA, rapidly increases lung function and maintains control over 24 h when administered twice daily (b.i.d.)…”

Comparison of the efficacy and safety of mometasone furoate dry powder inhaler to budesonide Turbuhaler

“…At screening, median plasma cortisol levels were 13.3 mg . dL [12,13] which demonstrated MF DPI to be effective and well tolerated. In the present study, MF DPI was directly compared to a clinically effective and widely used inhaled glucocorticoid, BUD Turbuhaler1.…”

“…min -1 [11]. The MF DPI was shown to be very effective in the treatment of mild to moderate persistent asthma [12,13].…”

“…This randomized, evaluator-blind, active-controlled study compared the efficacy and safety of MF DPI in doses of 100, 200, and 400 mg b.i.d to a single dose of BUD (400 mg by Turbuhaler1, b.i.d) in patients who were previously maintained on daily inhaled corticosteroids for treatment of their moderate persistent asthma. These doses of MF were chosen based on the results from a previous study [12] that indicated efficacy and safety of MF across this dose range in a population of adult and adolescent patients with moderate persistent asthma. The 400 mg b.i.d dose of BUD Turbuhaler1 was chosen for comparison since it is a dose commonly used worldwide to treat patients with moderate persistent asthma.…”

Eficácia e segurança de dois inaladores de pó seco usados para a aplicação de furoato de mometasona em pacientes com asma

“…(6) The dose of 400 µg administered in a single dose or in two sequential doses of 200 µg, once a day, was established as the preferred dosage regimen in terms of efficacy and safety. (7)(8)(9) Inhaled dry-powder MF can be stored in two ways: in a DPI that releases MF each time the device is rotated, during opening and closing, and that can contains multiple doses, or in a single-dose DPI that pierces a single-use capsule. Internationally, MF is administered via a multiple-dose DPI containing 30 or 60 doses of 100 µg or 200 µg.…”