mometasone-furoate and Acute-Disease

A 2-arm, double-blinded randomized trial was conducted to evaluate the efficacy of 0.1% mometasone furoate (MF) versus Eucerin Original (E) cream in preventing the development of moderate to severe acute radiation dermatitis (ARD) in breast cancer patients receiving postmastectomy radiation (PMRT).. Breast cancer patients undergoing chest wall with or without nodal radiation therapy (RT) (50 Gy) were eligible. Randomization (1:1) was to MF or E, applied twice daily from day 1 of PMRT to 14 days after PMRT. Patients were stratified by RT technique, body mass index, and reconstruction status. Daily bolus of 3 to 10 mm was applied in all patients. The primary endpoint was the development of provider-assessed grade ≥2 (Common Terminology Criteria for Adverse Events version 4.03) ARD with moist desquamation or any grade ≥3 dermatitis. Secondary endpoints were time to occurrence of maximum-grade dermatitis and patient-reported skin symptoms using a skin-related quality of life questionnaire, Skindex-16. Assessments were performed at baseline, weekly during PMRT, and 2 weeks after PMRT.. 124 patients were enrolled between May 2013 and February 2016. Of those, 35% had pathologic stage III disease, 6% had cT4d disease, and 68% underwent reconstruction. Sixty percent received 3-dimensional conformal RT with photons only to the chest wall, 18% received electrons and photons, and 23% received inverse-planned intensity modulated RT. Groups were well balanced for age, skin type, and stage. The rate of moist desquamation was 54.8% in the entire cohort, with a significantly reduced incidence in the MF arm than in the E arm (43.8% vs 66.7%; P = .012). The MF arm had a lower incidence of maximum skin toxicities (P = .036) and longer time to development of grade 3 dermatitis (46 days vs 35.5 days, respectively; P ≤ .001). There was no difference in patient-reported skin outcomes between arms.. Breast cancer patients receiving MF during PMRT experienced significantly reduced rates of moist desquamation in comparison with a control cream.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Breast Neoplasms; Dermatologic Agents; Double-Blind Method; Female; Humans; Lipids; Mastectomy; Middle Aged; Mometasone Furoate; Ointment Bases; Postoperative Care; Quality of Life; Radiodermatitis; Thoracic Wall; Treatment Outcome

Acute rhinosinusitis (ARS) is triggered by viral or, uncommonly, bacterial infection, causing inflammatory symptoms for ≤12 weeks.. To investigate effects of mometasone furoate nasal spray (MFNS) vs amoxicillin and placebo on minimal-symptom days.. A double-blind, parallel-group, placebo- and active-controlled 15-day study randomly assigned patients 12 years of age or older to MFNS 200 μg twice daily, MFNS 200 μg once daily, amoxicillin 500 mg 3 times daily, or placebo. Patients had baseline rhinosinusitis major symptom score (MSS; combined rhinorrhea, postnasal drip, congestion, sinus headache, facial pain) of ≥5 and ≤12 (maximum: 15) for 7 to 28 days; scores were similar among groups. Minimal-symptom days and minimal-congestion days were defined post hoc by average am/pm MSS ≤4 and average AM/PM congestion ≤1.. MFNS twice daily (n = 234) showed more minimal-symptom days vs placebo (n = 246) (62.69% vs 50.33%; P < .0001) or amoxicillin (n = 248) (54.35%; P = .0040). The MFNS QD was associated with numerically more minimal-symptom days than amoxicillin or placebo (54.72%; P ≤ .8982). MFNS was associated with more minimal-congestion days than placebo (72.97%, 67.73%, and 56.67% for twice daily, once daily, and placebo; P < .0001, each vs placebo) and MFNS BID with more minimal-congestion days than amoxicillin (72.97% vs 64.15%; P = .0007). Median time to first minimal-symptom day sustained until study end was 8.5 days for MFNS BID vs. 11 for placebo (P = .0085).. MFNS 200 μg twice daily significantly increased minimal-symptom days vs amoxicillin or placebo in patients with ARS. Results of this intranasal corticosteroids (INS) therapy indicate it can improve outcomes and potentially reduce inappropriate antibiotic use.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Amoxicillin; Anti-Inflammatory Agents; Child; Disease Progression; Disease-Free Survival; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Sprays; Pregnadienediols; Rhinitis; Sinusitis; Young Adult

Acute rhinosinusitis is a common disease with an increasing incidence rate. It causes substantial costs to the individual and to society through healthcare consumption and absence from work. The use of antibiotics is widespread in the treatment of acute rhinosinusitis, but increasing bacterial resistance is an argument for restricting excessive use of antibiotics.. The aim of this study was to analyse the cost-effectiveness of mometasone furoate nasal spray (MFNS) compared with amoxicillin or non-active treatment of mild to moderate acute rhinosinusitis in a Swedish setting.. A cost-effectiveness model was developed to capture the costs and health-related quality of life (HRQoL) over a 15-day period. Acute rhinosinusitis was modelled as changes in the Major Symptom Score. The model takes on a societal perspective in a Swedish setting. Efficacy data were taken from a randomised clinical study. The model has three treatment arms: (A) MFNS 200 μg twice daily, (B) amoxicillin 500 mg three times daily, and (C) placebo. Information about resource utilisation and HRQoL was taken from a recent observational study.. Costs were reduced and quality-adjusted life years were increased with MFNS 200 μg twice daily compared with amoxicillin 500 mg three times daily. MFNS was cost-saving or cost-effective compared with amoxicillin or non-active treatment in the sensitivity analyses regardless of the HRQoL measurement used.. This study shows that treatment with MFNS 200 μg twice daily results in lower costs and improved HRQoL in acute rhinosinusitis compared with amoxicillin or self-medication.

Topics: Acute Disease; Amoxicillin; Anti-Bacterial Agents; Cost-Benefit Analysis; Humans; Mometasone Furoate; Nasal Sprays; Pregnadienediols; Quality of Life; Rhinosporidiosis; Sweden

A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy.. Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy.. A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002).. Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Dermatologic Agents; Double-Blind Method; Female; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Pruritus; Radiodermatitis

Intranasal corticosteroids used with antibiotics are known to improve rhinosinusitis symptoms compared with antibiotic therapy alone. However, the efficacy of intranasal corticosteroid monotherapy for acute, uncomplicated rhinosinusitis is not established.. To evaluate efficacy and safety of mometasone furoate nasal spray (MFNS) versus amoxicillin and placebo in patients with acute, uncomplicated rhinosinusitis.. In this double-blind, double-dummy trial, subjects (> or =12 years; N = 981) were randomized to MFNS 200 microg once daily or twice daily for 15 days, amoxicillin 500 mg 3 times daily for 10 days, or respective placebo. Follow-up was 14 days. The primary efficacy endpoint was mean am/pm major symptom score over the treatment phase. Secondary efficacy endpoints included total symptom score. Safety assessments included disease recurrence during follow-up and adverse event monitoring.. Mometasone furoate nasal spray 200 microg twice daily was significantly superior to placebo (P < .001) and amoxicillin (P = .002) at improving major symptom score. Starting on day 2, MFNS 200 microg twice daily improved total symptom score throughout treatment versus amoxicillin (P = .012) and placebo (P < .001). Global response to treatment was significantly greater with MFNS 200 microg twice daily versus amoxicillin (P = .013) and placebo (P = .001). Although significantly superior to placebo, MFNS 200 microg once daily was not superior to amoxicillin for the primary or secondary efficacy endpoints. All treatments were well tolerated with a similar incidence of adverse events.. In patients with acute, uncomplicated rhinosinusitis, MFNS 200 microg twice daily produced significant symptom improvements versus amoxicillin and placebo, without predisposing the patient to disease recurrence or bacterial infection.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Adult; Aged; Amoxicillin; Child; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Rhinitis; Sinusitis

Mometasone furoate nasal spray (MFNS) 400 microg, twice daily, as adjunctive treatment with oral antibiotic significantly improved symptoms of recurrent rhinosinusitis.. To evaluate the effectiveness and safety of MFNS 200 microg, twice daily, and 400 microg, twice daily, compared with placebo as adjunctive treatment with oral antibiotic for acute rhinosinusitis.. In this multicenter, double-blind, placebo-controlled study, 967 outpatients with computed tomographic scan-confirmed moderate to severe rhinosinusitis received amoxicillin/clavulanate potassium (Augmentin, GlaxoSmithKline, Research Triangle Park, NC) 875 mg, twice daily, for 21 days with adjunctive twice daily MFNS 200 microg, MFNS 400 microg, or placebo nasal spray. Patients recorded scores of six rhinosinusitis symptoms and any adverse events twice daily. Pre- and postcosyntropin-stimulation plasma cortisol levels were measured in a subset of patients at selected study sites.. Treatment with MFNS 200 microg or 400 microg, twice daily, produced significantly greater improvements in total symptoms score (primary efficacy variable) day 1 to day 15 average (50% and 51%, respectively) than placebo (44%, P < or = 0.017). Both doses of MFNS produced significant total symptoms score improvement over placebo by day 4, and maintained efficacy over the entire 21-day study. Relief of individual symptoms showed a similar pattern. Both doses of MFNS were well tolerated, and adverse events were similar to that of placebo. Cosyntropin stimulation showed no evidence of hypothalamic-pituitary-adrenal axis suppression.. As adjunctive therapy to oral antibiotic treatment, MFNS at doses of 200 microg or 400 microg, twice daily, was well tolerated and significantly more effective in reducing the symptoms of rhinosinusitis than antibiotic therapy alone.

Topics: Acute Disease; Administration, Intranasal; Adolescent; Adult; Aerosols; Aged; Anti-Inflammatory Agents; Child; Cosyntropin; Dose-Response Relationship, Drug; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Hydrocortisone; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Sinusitis; Treatment Outcome

Radiation-induced dermatitis is a very common side effect of radiation therapy, and may necessitate interruption of the therapy. There is a substantial lack of evidence-based treatments for this condition. The aim of this study was to investigate the effect of mometasone furoate cream (MMF) on radiation dermatitis in a prospective, double-blind, randomized study.. The study comprised 49 patients with node-negative breast cancer. They were operated on with sector resection and scheduled for postoperative radiotherapy using photons with identical radiation qualities and dosage to the breast parenchyma. The patients were randomized to receive either MMF or emollient cream. The cream was applied on the irradiated skin twice a week from the start of radiotherapy until the 12th fraction (24 Gy) and thereafter once daily until 3 weeks after completion of radiation. Both groups additionally received non-blinded emollient cream daily. The intensity of the acute radiation dermatitis was evaluated on a weekly basis regarding erythema and pigmentation, using a reflectance spectrophotometer together with visual scoring of the skin reactions.. MMF in combination with emollient cream treatment significantly decreased acute radiation dermatitis (P=0.0033) compared with emollient cream alone. There was no significant difference in pigmentation between the two groups.. Adding MMF, a potent topical corticosteroid, to an emollient cream is statistically significantly more effective than emollient cream alone in reducing acute radiation dermatitis.

Topics: Acute Disease; Administration, Topical; Aged; Anti-Inflammatory Agents; Breast Neoplasms; Double-Blind Method; Emollients; Female; Follow-Up Studies; Glucocorticoids; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Radiodermatitis; Radiotherapy; Treatment Outcome; World Health Organization

Acute lymphoblastic leukemia (ALL) is the most common cancer before the age of 15 years, seriously endangering the health of children. The main treatment for Childhood ALL was pharmacotherapy. But these drugs have many side effects and some of them could develop drug resistance quickly. Mometasone furoate (MF) is an efficient glucocorticoid for topical treatment of inflammation on the skin, lung and nose.. In this study, we investigated whether the MF had effects on ALL cells proliferation and migration.. The CCK-8 proliferation test showed that the cell viability was the lowest at 25 nM MF treatment and the increased OD value was time-dependent. In transwell assay, the number of CCRF-CEM cells was reduced in MF treated group. We found the expression of anti-apoptotic protein bcl-2 decreased the expression of pro-apoptotic protein caspase3 and bax increased in CCRF-CEM cell line treated with MF. The expression of p-AKT, p-mTOR, p70S6 K, vascular endothelial growth factor and CyclinD1 were decreased in MF treated group.. This study reveals that MF can inhibit proliferation and invasion/migration and induce apoptosis in Childhood ALL cells, which may be regulated by Phosphatidylinositol 3-kinase signaling pathway. These results suggest MF may be a potential new drug target for clinical ALL treatment.

Topics: Acute Disease; Adolescent; Cell Line, Tumor; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Leukemia; Male; Mometasone Furoate; Neoplasm Proteins; Phosphatidylinositol 3-Kinases; Signal Transduction

Topics: Acute Disease; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Antipruritics; Biopsy; Drug Therapy, Combination; Exanthema; Groin; Humans; Hydroxyzine; Male; Mometasone Furoate; Pityriasis Rosea; Pregnadienediols; Roxithromycin; Treatment Outcome

In this evidence-based case report we studied the clinical question: Does intranasal corticosteroid (INCS) monotherapy reduce time to recovery in adults with acute noncomplicated rhinosinusitis? The search yielded 490 papers, of which only two were relevant and had a high validity regarding our clinical question.

Topics: Acute Disease; Administration, Intranasal; Adult; Amoxicillin; Budesonide; Evidence-Based Medicine; Female; Glucocorticoids; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis; Sinusitis; Treatment Outcome

Sinusitis or acute rhinosinusitis, is defined as an acute viral or bacterial infection characterised by inflammation of the mucosa of the nose and paranasal sinuses. Although antibiotics are routinely prescribed for the treatment of acute sinusitis, most cases are caused by viral infections and will resolve without antibiotic therapy. Given concerns about global antibacterial resistance, evidence-based clinical practice guidelines recommend a conservative approach to antibiotic treatment, with mild or moderately severe acute sinusitis managed symptomatically. Intranasal corticosteroids act on the nasal mucosa to relieve inflammation and its associated symptoms, and may be a useful symptomatic treatment option. Two randomised, placebo-controlled trials have demonstrated that the corticosteroid mometasone furoate, administered as a nasal spray (MFNS), is effective as an adjunct to antibiotics in acute sinusitis. The design of these studies show a therapeutic approach known in Europe, but this attitude is still different from the current French guidelines. Furthermore, the efficacy and safety of MFNS monotherapy has been compared with antibiotic therapy in a randomised, double-blind, placebo-controlled trial in adults with acute uncomplicated sinusitis and probably viral. In this study, twice-daily (BID) MFNS 200 microg produced statistically greater improvements in overall symptoms and most individual symptoms compared with amoxicillin or placebo, even though Amoxicillin is not the one recommended by the French guidelines for this indication. These findings suggest that MFNS may play an important role in the management of acute sinusitis, either as monotherapy or as adjunctive treatment to antibiotics. These results lead also to think over its interest in the treatment of uncomplicated common forms of sinusitis, where antibiotics are still widely prescribed in daily practice.

Topics: Acute Disease; Administration, Intranasal; Adult; Aerosols; Amoxicillin; Anti-Allergic Agents; Anti-Bacterial Agents; Anti-Inflammatory Agents; Double-Blind Method; Humans; Mometasone Furoate; Nasal Mucosa; Placebos; Pregnadienediols; Randomized Controlled Trials as Topic; Rhinitis; Safety; Sinusitis; Treatment Outcome

Topics: Acute Disease; Bacterial Infections; Ceftibuten; Cephalosporins; Chronic Disease; Clavulanic Acid; Drug Resistance, Multiple; Humans; Mometasone Furoate; Penicillanic Acid; Pregnadienediols; Sinusitis; Treatment Outcome

Topics: Acute Disease; Administration, Inhalation; Aerosols; Anti-Allergic Agents; Anti-Bacterial Agents; Anti-Inflammatory Agents; Drug Therapy, Combination; Humans; Inflammation; Mometasone Furoate; Pregnadienediols; Recurrence; Severity of Illness Index; Sinusitis; Treatment Outcome

Topics: Acute Disease; Administration, Intranasal; Anti-Inflammatory Agents; Clinical Trials as Topic; Drug Therapy, Combination; Humans; Mometasone Furoate; Pregnadienediols; Sinusitis