Mometasone Furoate Dry Powder Inhaler Research Articles

Investigation of Appropriate Inhalation Technique for Mometasone Furoate Dry Powder Inhaler.

The aim of this study was to establish an appropriate inhalation method with a mometasone furoate dry powder inhaler (MF-DPI). Utilizing a tone-based inhalation training device, we investigated the maximum peak inspiratory flow rate time (Tmax PIFR) and peak inspiratory flow rate (PIFR) to determine whether either had an influence on lung deposition with use of an MF-DPI. A low tone indicated a PIFR of 28 L/min and a high tone that of 40 L/min, while 60 L/min was considered to be the standard. We established an inhalation profile in consideration of a human inhalation pattern, in which Tmax PIFR was set at 0.5 s (Tmax PIFR 0.5 s) and 2.5 s (Tmax PIFR 2.5 s). The reference cut-off value derived with a cascade impactor test was used for evaluation of the rate of delivered dose in the lung, which was the amount of drug from stage 3 to 7 at all PIFRs. We then investigated the relationship of the fine particle fraction (FPF) with the claimed dose at Tmax PIFR of 0.5 s and PIFR. There were no differences among the Tmax PIFR values for the doses emitted from the device or for the rate of delivered doses in stages 3-7. However, FPF for the claimed dose at 40 L/min was significantly lower than that at 60 L/min, which was dependent on PIFR. Our results showed that PIFR but not Tmax PIFR has an effect on lung deposition after inhalation with an MF-DPI.

Comparison of the systemic bioavailability of mometasone furoate after oral inhalation from a mometasone furoate/formoterol fumarate metered-dose inhaler versus a mometasone furoate dry-powder inhaler in patients with chronic obstructive pulmonary disease

BackgroundCoadministration of mometasone furoate (MF) and formoterol fumarate (F) produces additive effects for improving symptoms and lung function and reduces exacerbations in patients with asthma and chronic obstructive pulmonary disease (COPD). The present study assessed the relative systemic exposure to MF and characterized the pharmacokinetics of MF and formoterol in patients with COPD.MethodsThis was a single-center, randomized, open-label, multiple-dose, three-period, three-treatment crossover study. The following three treatments were self-administered by patients (n = 14) with moderate-to-severe COPD: MF 400 μg/F 10 μg via a metered-dose inhaler (MF/F MDI; DULERA®/ZENHALE®) without a spacer device, MF/F MDI with a spacer, or MF 400 μg via a dry-powder inhaler (DPI; ASMANEX® TWISTHALER®) twice daily for 5 days. Plasma samples for MF and formoterol assay were obtained predose and at prespecified time points after the last (morning) dose on day 5 of each period of the crossover. The geometric mean ratio (GMR) as a percent and the corresponding 90% confidence intervals (CI) were calculated for treatment comparisons.ResultsSystemic MF exposure was lower (GMR 77%; 90% CI 58, 102) following administration by MF/F MDI compared to MF DPI. Additionally, least squares geometric mean systemic exposures of MF and formoterol were lower (GMR 72%; 90% CI 61, 84) and (GMR 62%; 90% CI 52, 74), respectively, following administration by MF/F MDI in conjunction with a spacer compared to MF/F MDI without a spacer. MF/F MDI had a similar adverse experience profile as that seen with MF DPI. All adverse experiences were either mild or moderate in severity; no serious adverse experience was reported.ConclusionSystemic MF exposures were lower following administration by MF/F MDI compared with MF DPI. Additionally, systemic MF and formoterol exposures were lower following administration by MF/F MDI with a spacer versus without a spacer. The magnitude of these differences with respect to systemic exposure was not clinically relevant.

Mometasone furoate dry powder inhaler for the treatment of asthma

The review is focused on inhaled mometasone furoate (Asmanex Twisthaler), a new medication for the treatment of asthma in adults and childred (12 years and older). Mometasone furoate (MF) has high antiinflammatory activity and low systemic bioavalability. MF has an excellent safety and efficacy profile in approved doses 200—800 mcg/daily od (in the evening) or bid (in the morning and in the evening). For patients with persistent asthma required treatment with an inhaled corticosteroid, MF is an excellent therapeutic choice.

Mometasone furoate dry powder inhaler for the treatment of asthma

Introduction: Asthma is a chronic inflammatory disease that causes significant morbidity and mortality. Inhaled corticosteroids are the preferred initial treatment for this disorder. Mometasone furoate dry powder is an inhaled corticosteroid that is approved for once-daily treatment of asthma in both adults and children as young as 4 years.Areas covered: The goal of this paper is to review the clinical efficacy and safety of mometasone furoate dry powder inhaler for the treatment of asthma. A literature search using PubMed was done using the terms ‘mometasone furoate’, ‘inhaled corticosteroid’ and ‘asthma’, focusing on articles that highlighted clinical trials and addressed efficacy of the medication.Expert opinion: Mometasone furoate dry powder inhaler has an excellent safety and efficacy profile. For patients with persistent asthma who require treatment with an inhaled corticosteroid, mometasone furoate is an excellent therapeutic choice.

Incidence of Exacerbations and Hospitalizations Is Reduced and Time to Exacerbations Is Prolonged with Mometasone Furoate Dry Powder Inhaler Versus Beclomethasone Dipropionate Hydrofluoroalkane Aerosol in Patients with Mild Asthma

Objective To compare the incidence and time to onset of exacerbations among mild asthmatic non-controller-naive patients who began treatment with mometasone furoate via a dry powder inhaler (MF-DPI) or a beclomethasone dipropionate-hydrofluoroalkane (BDP-HFA) aerosol inhaler. Study Design An administrative claims database was retrospectively examined from January 1, 2005 through June 30, 2008. Patients with mild asthma aged 12-65 years who were US residents and enrolled in their health plan for ≥1 year before and after the index date for MF-DPI or BDP-HFA treatment initiation were included (n = 1273 matched patients per cohort). Primary evaluations included the incidence of and time to any asthma exacerbations and several asthma exacerbation subtypes. Multivariate generalized linear regression modeling analyses were used to compare the postindex incidence of exacerbations between cohorts. Cox regression analyses were conducted to control for the impact of input variables and evaluate the time to exacerbations. Results Significantly fewer MF-DPI patients experienced an exacerbation compared with BDP-HFA patients (9.7% vs 11.5%, respectively; P = .0002). At all time points examined, fewer MF-DPI patients compared with BDP-HFA patients experienced any exacerbation or an exacerbation requiring inpatient hospitalization. The difference between cohorts in the incidence of inpatient exacerbations increased over time. MF-DPI patients experienced prolonged time to any asthma exacerbation (hazard ratio = 0.77; P = .0414) or exacerbations requiring inpatient hospitalization (hazard ratio = 0.51; P = .0191) compared with BDP-HFA patients. Conclusion These analyses suggest that patients (previously receiving asthma-related therapy) with mild asthma receiving MF-DPI are at lower risk for asthma exacerbations compared with those receiving BDP-HFA.

Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma

Exhaled nitric oxide (F(ENO)) and exhaled breath condensate (EBC) are noninvasive markers that directly measure airway inflammation and may potentially be useful in assessing asthma control and response to therapy. To examine the time-dependent effects of inhaled corticosteroids on F(ENO) and EBC markers concomitantly with lung function and bronchial hyperresponsiveness. Eleven steroid-naive adults with mild-to-moderate persistent asthma were treated with mometasone furoate dry powder inhaler, 400 microg/d, for 8 weeks, followed by a 4-week washout. Forced expiratory volume in 1 second (FEV1), the concentration of methacholine calculated to cause a 20% decline in FEV1 (PC20), F(ENO), EBC pH, and EBC nitrite measurements before, during, and after treatment were analyzed and compared. The mean (SEM) FEV1 increased from 3.01 (0.13) L (82% predicted) to 3.24 (0.18) L (87% predicted) by week 8 (P < .05). The PC20 level increased from 1.28 (0.31) mg/mL to 2.99 (0.51) mg/mL by treatment week 8 (P < .05) and remained relatively stable through washout week 4 (P < .05). The F(ENO) level decreased from 31.1 (4.1) ppb to 20.6 (4.5) ppb by treatment week 1 (P < .01), remained low through treatment week 8 (P < .01), then trended back to the baseline level by washout week 1 (P < .01). The median EBC pH increased from 7.81 (interquartile range, 7.49-8.09) to 8.02 (interquartile range, 7.87-8.12) by treatment week 4, but did not achieve statistical significance. The EBC nitrite level decreased from 17.6 (1.6) microM to 9.3 (0.9) microM by treatment week 8 (P < .01), and remained low throughout washout week 4 (P < .05). There was a negative correlation between F(ENO) and PC20 (Spearman rank correlation coefficient = -0.50, P < .001). The F(ENO) level responded the earliest to treatment and withdrawal of inhaled corticosteroids, whereas changes in EBC markers were delayed but more sustained.

Comparable morning versus evening administration of once-daily mometasone furoate dry powder inhaler

The control of daytime and nighttime symptoms is an important measure of effectiveness of asthma therapy, especially, when administered once-daily. To evaluate the efficacy of evening and morning administrations of mometasone furoate administered via a dry powder inhaler (MF-DPI) 400 microg once-daily (QD) to show equivalence. Open-label, randomized, parallel-group study in adult patients with mild to moderate asthma with a > or = 3-month history of ICS use. Patients received MF-DPI 400 microg QD either in the morning (AM) or evening (PM) for 12 weeks. The primary measure was the change in asthma symptoms from baseline to week 12. Secondary outcomes included response to treatment, adherence, inhaler device evaluation, use of rescue medication, urinary cortisol levels, and differential white blood cell count. A total of 1537 patients were randomized; the efficacy population comprised 543 and 479 patients in the MF-DPI QD morning and evening groups, respectively. Mean improvements from baseline in daytime symptom scores at week 12 with morning and evening administration of MF-DPI 400 microg were -0.11+/-0.59 and -0.12+/-0.68, respectively (95% CI, -0.095 to 0.061) and the corresponding improvements in nighttime symptom scores were -0.08+/-0.59 and -0.07+/-0.50, respectively (95% CI, -0.067 to 0.068). Use of rescue medication was the same in both groups (1 puff/day). MF-DPI QD was well tolerated regardless of time of administration. This open-label study did not identify differences between morning and evening dosing of MF-DPI 400 microg QD. A better effect of evening dosing compared to morning dosing found in previous double-blind placebo-controlled studies could not be confirmed.

Once Daily Evening Dosing of Mometasone Furoate Dry Powder Inhaler 200 μg is Effective in Patients with Moderate Persistent Asthma

Once Daily Evening Dosing of Mometasone Furoate Dry Powder Inhaler 200 μg is Effective in Patients with Moderate Persistent Asthma

Comparison of Mometasone Furoate Dry Powder Inhaler and Fluticasone Propionate Dry Powder Inhaler in Patients with Moderate to Severe Persistent Asthma Requiring High-Dose Inhaled Corticosteroid Therapy: Findings from a Noninferiority Trial

Background. Inhaled corticosteroids (ICSs) are one of the suggested first-line therapies for patients with persistent asthma of moderate severity. Methods: The efficacy and safety of mometasone furoate (MF) 400 μg twice daily (BID) and fluticasone propionate (FP) 500 μ g BID administered for 12 weeks via dry powder inhaler (DPI) were compared in a noninferiority trial, in adults with moderate-to-severe persistent asthma. The primary variable was the change from baseline in am peak expiratory flow rate (PEFR). pm PEFR, forced expiratory volume in 1 second (FEV1), asthma symptoms, rescue medication use, response to therapy, exacerbation rates, and adverse events were also assessed. Results. The lower bound of 95% CIs for treatment differences in the primary variable ranged from 2.6% to 5.6% throughout the 12-week study and were within the prespecified noninferiority range. No significant between-group differences were observed in lung function, rescue medication use, response to therapy, exacerbation rates, or adverse events. At most of the weeks assessed, there were no between-group differences in asthma symptoms. Most adverse events were mild-to-moderate. Conclusion. MF-DPI 400 μ g BID was therapeutically equivalent to FP-DPI 500 μ g BID in patients with moderate-to-severe persistent asthma.

Mometasone furoate dry-powder inhaler for the control of persistent asthma

Mometasone furoate dry-powder inhaler (MF-DPI) is an inhaled corticosteroid (ICS) used for the treatment of persistent asthma in patients aged ≥ 12 years. MF-DPI has low systemic bioavailability and high glucocorticoid receptor affinity compared with most other ICSs and modifies inflammatory mediators involved in the pathogenesis of asthma. MF-DPI, unlike other available ICSs, is approved for initiation as a once-daily in the afternoon (q.d. PM) regimen. Studies show that MF-DPI 200 or 400 μg q.d. PM treatment significantly improves lung function and symptom control in patients with mild, moderate or severe asthma. MF-DPI 400 μg q.d. PM is reported to be equivalent to fluticasone propionate 250 μg b.i.d. and beclometasone dipropionate 168 μg b.i.d. and more efficacious than budesonide 400 μg, b.i.d. or q.d. MF-DPI is generally well tolerated, with minimal effects on the hypothalamic-pituitary-adrenal axis.

TWICE-DAILY TREATMENT WITH MOMETASONE FUROATE DRY-POWDER INHALER 100 MICROGRAMS DID NOT EXERT A SYSTEMIC EFFECT AS MEASURED BY PLASMA CORTISOL LEVELS: FINDINGS FROM A PEDIATRIC ASTHMA PLACEBO-CONTROLLED CLINICAL TRIAL

PURPOSE: Assessing systemic effects that inhaled corticosteroids may exert in children with asthma is of great importance. We report findings from a pediatric study investigating the effects of mometasone furoate dry-powder inhaler (MF-DPI) on the hypothalamic-pituitary-adrenal axis. Unlike previously published investigations in children, systemic effects were monitored in a strictly controlled hospital inpatient setting.

Effects of treatment with mometasone furoate dry powder inhaler in children with persistent asthma

Mometasone furoate dry powder inhaler (DPI) has been shown to effectively treat asthma in children. To evaluate the efficacy and safety of 2 dosing regimens of mometasone furoate DPI in the treatment of mild-to-moderate persistent asthma in children previously using inhaled corticosteroids (ICSs). A 12-week, multicenter, double-blind, parallel-group, placebo-controlled study evaluated 2 dosing regimens of mometasone furoate DPI (100 microg every evening and 100 microg twice daily) in 296 children 4 to 11 years old with asthma previously using ICSs. The primary efficacy variable was the change in percentage of predicted forced expiratory volume in 1 second (FEV1) from baseline to end point. Secondary efficacy variables included absolute FEV1, forced expiratory flow between 25% and 75% forced vital capacity, morning and evening peak expiratory flow, asthma symptom scores, albuterol use, nocturnal awakenings, response to therapy, and health-related quality of life. Mean changes from baseline at end point in predicted FEV1 were 4.73 and 5.52 percentage points for mometasone furoate DPI, 100 microg every evening and 100 microg twice daily, respectively, the difference of which was not significant, and -1.77 percentage points for placebo (P < or = .002). Significant improvements in secondary efficacy variables were also observed for both mometasone furoate DPI treatments over placebo. Both mometasone furoate DPI doses were well tolerated, and no significant differences were noted among the 3 treatment groups in adverse event reporting. Both mometasone furoate DPI doses were well tolerated and significantly improved lung function, maintained effective asthma control, and improved quality of life in children with asthma.

Once-daily evening administration of mometasone furoate in asthma treatment initiation

In a previous study, a 200-microg once-daily evening dose of mometasone furoate dry powder inhaler (DPI) was effective in patients with asthma previously taking inhaled corticosteroids. No studies have been conducted to test the effect of a once-daily evening dose in patients previously using only short-acting beta2-adrenergic agonists (SABAs) for symptom relief. To evaluate the effectiveness of mometasone furoate DPI administered once daily in the evening as initial controller therapy in patients previously using SABAs alone for asthma. Patients with mild-to-moderate persistent asthma from 18 US centers participated in a 12-week, randomized, double-blind, placebo-controlled study. Patients received either mometasone furoate DPI, 200 microg, or placebo once daily in the evening. The primary efficacy variable was the change in forced expiratory volume in 1 second from baseline to the end point (last evaluable visit). Other measurements included forced vital capacity, forced expiratory flow between 25% and 75%, morning and evening peak expiratory flow, asthma symptoms, use of albuterol, nocturnal awakenings, physicians' evaluation of response to therapy, and time to asthma worsening. At the end point, the mean increase in forced expiratory volume in 1 second relative to baseline for the mometasone furoate DPI group of 0.43 L (16.8%) was significantly greater than that for the placebo group of 0.16 L (6.0%) (P < .01). Morning peak expiratory flow, forced vital capacity, and forced expiratory flow between 25% and 75% also significantly improved with mometasone furoate DPI treatment relative to placebo (P < .01). Once-daily dosing with mometasone furoate DPI was well tolerated. Mometasone furoate DPI (200 microg) administered once daily in the evening significantly improves pulmonary function in patients previously using SABAs alone for asthma control.

Effect of Once-Daily Evening Administration of Low-Dose Mometasone Furoate on Peak Expiratory Flow in Subjects With Mild-to-Moderate Persistent Asthma

RATIONALE: The ability of inhaled corticosteroid (ICS) therapy to improve peak expiratory flow (PEF) throughout the day is an important measure of asthma control. It was decided to analyze the effects on PEF measurements observed with once-daily evening (QD PM) dosing of mometasone furoate dry powder inhaler (MF-DPI) in different populations of asthma patients. METHODS: Two randomized, double-blind studies evaluated treatment with MF-DPI 220 mcg QD PM (n = 177) or placebo (n = 178) in 12 weeks of therapy for persistent asthma. Subjects in one study were ICS-naïve. Subjects in the other study were previously maintained on daily ICS therapy (75% were using fluticasone propionate), and completed a pre-baseline ICS reduction period. As a result, subjects in both studies were comparable at baseline with respect to lung function and were pooled for analysis. The analysis compared MF-DPI with placebo for changes from baseline in AM and PM PEF at endpoint. RESULTS: Treatment with MF-DPI 200 QD PM significantly improved AM and PM PEF. The mean change from baseline in AM PEF at endpoint was 28.01 L/min in the MF-DPI group, compared with 3.12 L/min in the placebo group (p < 0.0001). For PM PEF, the mean change from baseline was 21.06 L/min with MF-DPI, and 5.92 with placebo (p = 0.0022). CONCLUSIONS: Treatment with MF-DPI 220 mcg QD PM significantly improved both AM and PM PEF in patients with persistent asthma who were either ICS-naïve or previously maintained on daily ICS therapy.

Effects of Mometasone Furoate Given Once Daily in the Evening on Lung Function and Symptom Control in Persistent Asthma

The chronobiology of asthma suggests that, for once-daily dosing, an evening dose may be the most effective treatment paradigm. To evaluate the efficacy and safety of mometasone furoate dry powder inhaler (MF-DPI) administered once daily in the evening or twice daily in patients with asthma previously maintained on twice-daily regimens of inhaled corticosteroids. In this 12-week, multicenter, placebo-controlled trial, 268 subjects > or =12 years of age with inhaled corticosteroid-dependent asthma and baseline forced expiratory volume in 1 second (FEV(1)) between 50% and 85% of predicted were randomized to receive treatment with MF-DPI 400 mug once daily in the evening, MF-DPI 200 mug twice daily, or placebo. The primary efficacy variable was mean change in FEV(1) from baseline to endpoint. Other lung function measures, asthma symptoms, quality of life, and rescue medication use also were assessed. At endpoint, mean FEV(1) was significantly improved with both MF-DPI doses compared with placebo (p < 0.001). The 2 active treatment groups were statistically indistinguishable from each other. Secondary efficacy variables, including nocturnal awakenings, asthma worsenings, quality of life, and rescue medication use, were also significantly improved for both MF-DPI treatments compared with placebo. Both dosages were well tolerated; no clinically meaningful changes in laboratory values or vital signs were observed. MF-DPI 400 mug once daily in the evening was as effective as MF-DPI 200 mug twice daily in improving pulmonary function, asthma symptoms, and quality of life compared with placebo in subjects previously using twice-daily regimens of an inhaled corticosteroid.

Efficacy and safety of mometasone furoate administered once-daily in the evening in patients with persistent asthma dependent on inhaled corticosteroids

ABSTRACTBackground: Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing.Objective: The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 µg qd PM (one 400 g inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo.Methods: This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 µg qd (once a day, quaque die) PM, 400 µg qd PM as one inhalation from a 400 µg device, 400 µg qd PM as two inhalations from a 200 µg device, 200 µg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time.Results: Mean changes from baseline at endpoint in FEV1 (forced expiratory volume in 1 s) were similar for MF-DPI 400 µg qd PM (one inhalation; 0.41 L), MF-DPI 400 g qd PM (2 inhalations; 0.49 L), MF-DPI 200 µg qd PM (0.41 L), and MF-DPI 200 µg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity.Conclusions: Once-daily evening dosing of MF-DPI at doses of 400 and 200 µg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 µg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 µg qd PM, the lowest dose studied.

Effects of Mometasone Furoate Dry Powder Inhaler and Beclomethasone Dipropionate Hydrofluoroalkane and Chlorofluorocarbon on the Hypothalamic-Pituitary-Adrenal Axis in Asthmatic Subjects

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. 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. 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. 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.

Improvements in health-related quality of life with once-daily (evening) or twice-daily dosing of mometasone furoate dry powder inhaler (MF-DPI) in children with asthma

16 Improvements in Health-Related Quality of Life With Once-Daily (Evening) or Twice-Daily Dosing of Mometasone Furoate Dry Powder Inhaler (MF-DPI) in Children With Asthma M. Noonan1, M. E. Ruff2, P. Chervinsky3, W. Berger4; 1Allergy Associates Research, Portland, OR, 2Pharmaceutical Research & Consulting, Dallas, TX, 3New England Clinical Studies, North Dartmouth, MA, 4Southern California Research, Mission Viejo, CA. RATIONALE: To evaluate the effects of mometasone furoate dry powder inhaler (MF-DPI) 100 mcg administered once daily in the evening (QD PM) on health-related quality of life (HQOL) in children with asthma previously maintained on inhaled corticosteroids (ICS). METHODS: A randomized, placebo-controlled, 12-week study in children (4 11 years of age) with asthma evaluated (as secondary efficacy variables) the HQOL effects of MF-DPI 100 mcg QD PM, MF-DPI 100 mcg BID, and placebo. The HQOL data were collected using the Child Health Questionnaire Parent Form (CHQ-PF28) and an asthma-specific module (ASM). The primary HQOL variables were changes from baseline in the physical summary score (PSS) of CHQ-PF28, and in the disability domain of the ASM. Data for the HQOL domains were analyzed for Week 8, Week 12 and endpoint using ANOVA. RESULTS: Of 296 randomized subjects, 292 (99%) completed both HQOL questionnaires at baseline and endpoint. Mean HQOL scores were similar among treatment groups at baseline, and suggested impaired function and well-being compared with the general population. At endpoint, the mean PSS improved significantly with MF-DPI 100 mcg QD PM vs placebo (3.4 and -2.1, respectively; p = 0.002). The mean ASM-disability score also improved significantly with MF-DPI 100 mcg QDPM vs placebo (9.2 and 0.3, respectively; p<0.001). Mean PSS and ASM-disability improvements with MF-DPI 100 mcg BID (2.3 and 6.8, respectively) were similar to those observed with MF-DPI 100 mcg QD PM. CONCLUSIONS: Treatment with MF-DPI 100 mcg QD PM significantly improves quality of life in children with asthma. Funding: Schering-Plough 18 Onset of Improvements of Lung Function With Mometasone Furoate Dry Powder Inhaler (MF-DPI) in ICS-Naive Patients With Asthma B. Prenner1, R. Berkowitz2, G. W. Bensch3, B. N. Lutsky4; 1Allergy Associates Medical Group, San Diego, CA, 2Rx Research, Atlanta Allergy & Asthma Clinic, Marietta, GA, 3Allergy, Immunology, and Asthma Medical Group, Stockton, CA, 4Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: To evaluate the onset of improvements in lung function with mometasone furoate dry powder inhaler (MF-DPI) administered as 200 mcg once daily in the evening (QD PM). METHODS: Randomized, double-blind, placebo-controlled, efficacy and safety study of 12 weeks of treatment with MF-DPI 200 mcg QD PM in subjects ≥12 years of age with asthma previously maintained on shortacting beta-agonists (SABA) alone. Changes from baseline in forced expiratory volume in 1 second (FEV1) at Weeks 1, 2, 4, 8, 12 and endpoint (primary variable) were assessed. RESULTS: Mean improvement from baseline in FEV1 was 11.7% at Week 1 (first assessment) in the MF-DPI group, compared with a 4.3% increase in the placebo group (p<.01). FEV1 improved consistently with MF-DPI throughout the study period, and improvements with MF-DPI at each assessment were significantly greater than those with placebo (p<.01). A mean increase of 18.5% was observed at Week 12, compared with a 7.6% increase with placebo (p<.01). At endpoint, the mean increase from baseline in FEV1 was 16.8% on MF-DPI, compared with 6% on placebo (p<.01). Treatment with MF-DPI was well tolerated, with no unusual or unexpected adverse events reported. No clinically meaningful changes in laboratory parameters, vital signs, or physical examinations were noted in either treatment group. CONCLUSIONS: In patients previously maintained with SABA alone, MF-DPI 200 mcg QD PM improved lung function rapidly and provided consistent improvements with continued treatment. The results reported here support and extend those observed in other studies in which MF-DPI 200 mcg QD PM was evaluated. Funding: Schering-Plough Research Institute

Assessment of the effective daily dose for mometasone furoate dry powder inhaler in the treatment of persistent asthma

RATIONALE: Mometasone furoate dry powder inhaler (MF-DPI) has been evaluated in several clinical studies for treatment of asthma at an initial dose of 400 mcg/day in mild and moderate persistent asthma. We analyzed the odds that asthma control can be maintained at a maintenance dose of 200 mcg/day. METHODS: Data were pooled from 4 placebo-controlled trials of MF-DPI with regard to asthma severity based on GINA guidelines. Severity was stratified into Steps 2 (mild persistent asthma) and 3 (moderate persistent asthma). The magnitude of response was based on combined increases in FEV1 (≥0.15 L) and AM PEF (≥10 L/min). Odds ratios (OR) and 95% confidence intervals were calculated for responses with MF-DPI 200 mcg/day vs 400 mcg/day, and MF-DPI 200 mcg/day vs placebo. RESULTS: For Step 2 patients (n = 126), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 1.0435 (0.4427, 2.4596); for MF-DPI 200 mcg/day vs placebo the OR was 3.1084 (1.0735, 8.9930). For Step 3 patients (n = 406), the OR of response to MF-DPI 200 mcg/day vs 400 mcg/day was 0.4990 (0.3054, 0.8159), and for MF-DPI 200 mcg/day vs placebo the OR was 2.3421 (1.3119, 4.1817). CONCLUSIONS: Step 2 subjects had approximately equal odds of responding to 200 mcg/day or 400 mcg/day. Although an apparent dose response was seen in Step 3 subjects, a substantial number of patients can be maintained on 200 mcg/day.

Onset of improvements of lung function with mometasone furoate dry powder inhaler (MF-DPI) in ICS-Naïve patients with asthma

Onset of improvements of lung function with mometasone furoate dry powder inhaler (MF-DPI) in ICS-Naïve patients with asthma