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PubMed | Mie National Hospital, Tokyo Metropolitan Childrens Medical Center, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Jikei Daisan Hospital and 12 more.
Type: Journal Article | Journal: Allergology international : official journal of the Japanese Society of Allergology | Year: 2016

Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population havent been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma.Thirty-eight Japanese children (aged 7-16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials.gov number: NCT01328886).Thirty-five patients (92.1%) completed the extension study. The median exposure throughout the core and extension studies was 116.6 weeks (range, 46.9-151.1 weeks). The most common adverse events were nasopharyngitis, influenza, upper respiratory tract infection, and asthma. Serious adverse events developed in 10 patients (26.3%), but resolved completely with additional treatments. Incidence of adverse events didnt increase with extended exposure with omalizumab. Twenty-nine patients (76.3%) achieved completely- or well-controlled asthma compared with 9 patients (23.7%) at the start of the extension study. QOL scores, the rates (per year) of hospitalizations and ER visits were significantly improved compared with the baseline of the core study [39.0 vs 48.0 (median), p<0.001 for QOL, 1.33 vs 0.16, p<0.001 for hospitalization, 0.68 vs 0.15, p=0.002 for ER visits]. Remarkably, the mean total IgE level showed a decreasing trend while exposure to omalizumab remained at steady-state.Long-term treatment with omalizumab is well-tolerated and effective in children with uncontrolled severe allergic asthma. No new safety findings were identified.

PubMed | Mie National Hospital, Tokyo Metropolitan Childrens Medical Center, Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Jikei Daisan Hospital and 12 more.
Type: Clinical Trial | Journal: Allergology international : official journal of the Japanese Society of Allergology | Year: 2015

Omalizumab has demonstrated clinical benefits in children with moderate to severe allergic asthma. However, no studies have been performed in Japanese asthmatic children. The aim of this study was to evaluate the efficacy including free IgE suppression and safety of omalizumab in Japanese children with severe allergic asthma. The primary objective was to examine whether omalizumab decreases serum free IgE levels to less than 25ng/ml (target level of suppression).Thirty-eight Japanese children (6-15 years) with uncontrolled severe allergic asthma despite inhaled corticosteroids (>200g/day fluticasone propionate or equivalent) and two or more controller therapies received add-on treatment with omalizumab in a 24-week, multicenter, uncontrolled, open-label study.The geometric mean serum free IgE level at 24 weeks was 15.6ng/mL. Compared with baseline, total asthma symptom scores, daily activity scores and nocturnal sleep scores at 24 weeks were significantly improved. The rates of asthma exacerbation and hospitalization due to asthma were reduced by 69.2% and 78.2%, respectively (p<0.001), versus baseline. Quality-of-life scores were also significantly improved (p<0.001). In addition, 11 (28.9%) patients reduced the dose of any asthma controller medications. Thirty-six (94.7%) patients experienced at least one adverse event during the treatment period. All adverse events were mild or moderate in severity and no new safety concerns were detected. No patients discontinued the study.In Japanese children with severe allergic asthma, omalizumab decreased free IgE levels to less than 25ng/mL. Omalizumab improved asthma control and was well-tolerated, as well.

PubMed | National Center for Global Health and Medicine, Tokyo Metropolitan Tama Medical Center, University of Tokyo, Tokyo Teishin Hospital and 4 more.
Type: Journal Article | Journal: World journal of urology | Year: 2016

Small cell carcinoma of the urinary bladder (SCCB) is known for its aggressive clinical features and poor prognosis. No prognostic factor has been established so far. The aim of this study was to assess the significance of possible prognostic factors, including serum neuron-specific enolase (NSE), an established biomarker for small cell lung carcinoma.We retrospectively reviewed 31 patients with primary SCCB treated at our eight affiliate institutions between 2001 and 2014. The association of various clinicopathological factors at diagnosis, including the serum NSE value, with cancer-specific survival (CSS) was assessed. The log-rank test and Cox proportional hazards model were used for univariate and multivariate analyses, respectively.Nineteen (61.3%) died of SCCB during the follow-up, with a median survival time of 12.7months. Prognostic factors were analyzed for the 25 patients after excluding six with missing data. Univariate analysis demonstrated that stage (extensive disease) and serum NSE 25ng/ml were significantly associated with worse CSS. Multivariate analysis identified increased serum NSE value as a sole independent predictor of CSS (hazard ratio 18.52, p=0.0022).Serum NSE value at diagnosis was an independent prognostic factor for primary SCCB and may serve as a useful biomarker in the management of SCCB.

PubMed | Kawada Children and Allergy Clinic, Mie National Hospital, National Hospital Organization Hiroshima Nishi Medical Center, Nippon Kokan Fukuyama Hospital and 13 more.
Type: Journal Article | Journal: Allergology international : official journal of the Japanese Society of Allergology | Year: 2016

Several guidelines, including the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL), recommend salmeterol/fluticasone combination therapy (SFC) as step 3 to 4 treatment for moderate to severe asthma. However, the optimal step-down approach to SFC remains unclear. In the current study, we examined step-down approaches in asthmatic children whose symptoms had been stabilized by SFC 100/200g/day.This randomized, multicenter, open-label, parallel-group study was conducted over 12 weeks. For step-down therapy, subjects aged 5-15 years were randomly assigned to an SFC group (25/50g b.i.d.) or an FP group (100g b.i.d.), and treated for 12 weeks. Childhood Asthma Control Test (C-ACT) scores, lung function, and exhaled nitric oxide (FeNO) levels were monitored.Of 131 enrolled subjects, 128 completed the study and were included in the analysis. Decreases in % peak expiratory flow rate and % forced expiratory flow at 50% of vital capacity (V50) were observed in the FP group at each time point. There was a significant difference between the two groups for the change in %V50 from its previous value at each time point. There were no significant changes in FeNO levels (range 15-20ppb) or C-ACT scores (26 points) within or between groups.A high level of asthma control was maintained with both approaches. The use of SFC step-down resulted in somewhat better respiratory function, with no worsening of airway inflammation. However, halving the dose of SFC and switching to FP alone are both optimal step-down approaches.

PubMed | National Hospital Organization Shimoshizu National Hospital, Arita Clinic of Pediatrics and Pediatric Allergy, Yamada Gastrointestinal Internal Medicine and Pediatric Clinic, Nishikawa Clinic and 6 more.
Type: Clinical Trial | Journal: Allergology international : official journal of the Japanese Society of Allergology | Year: 2015

If asthmatic children cannot obtain sufficient control of their disease, not only do they suffer from asthma symptoms, but the daily life activities of their caregivers are also disrupted. We investigated the effectiveness of an inhaled corticosteroid (ICS) for symptom control in previously ICS-untreated school-aged asthmatic children as well as caregiver treatment satisfaction (CTS).A multicenter, open-label, single-arm study on 12-week ICS (budesonide Turbuhaler) monotherapy was undertaken in subjects aged 5-15 years with bronchial asthma not treated with ICS during the previous 3 months. At 0, 4, 8, and 12 weeks after start of ICS administration, Japanese Pediatric Asthma Control Program (JPAC) scores, and CTS scores were summated and lung function measured. At weeks 0 and 12, questionnaires on caregiver anxiety were also assessed.Seventy-five patients were enrolled, and 69 assessed. Ninety percent of subjects had been treated with asthma controller medication except ICS before study enrollment. JPAC score and CTS score were improved significantly at weeks 4, 8, and 12 (p < 0.001). With regard to CTS, more than half of caregivers showed a perfect score at weeks 8 and 12. There was a significant correlation between JPAC score and CTS score. Lung function and caregiver anxiety were also improved, and good compliance with treatment was observed during the intervention.If treating ICS-untreated school-aged asthmatic children with uncontrolled symptoms, ICS monotherapy can improve CTS along with improving asthma control.

Urisu A.,Fujita Health University Hospital | Ebisawa M.,National Hospital Organization Sagamihara National Hospital | Mukoyama T.,The Fraternity Memorial Hospital | Morikawa A.,Kita Kanto Allergy Laboratory | Kondo N.,Gifu University
Allergology International | Year: 2011

Food allergy is defined as "a phenomenon in which adverse reactions (symptoms in skin, mucosal, digestive, respiratory systems, and anaphylactic reactions) are caused in living body through immunological mechanisms after intake of causative food." Various symptoms of food allergy occur in many organs. Food allergy falls into four general clinical types; 1) neonatal and infantile gastrointestinal allergy, 2) infantile atopic dermatitis associated with food allergy, 3) immediate symptoms (urticaria, anaphylaxis, etc.), and 4) food-dependent exercise-induced anaphylaxis and oral allergy syndrome (i.e., specific forms of immediate-type food allergy). Therapy for food allergy includes treatments of and prophylactic measures against hypersensitivity like anaphylaxis. A fundamental prophylactic measure is the elimination diet. However, elimination diets should be conducted only if they are inevitable because they places a burden on patients. For this purpose, it is highly important that causative foods are accurately identified. Many means to determine the causative foods are available, including history taking, skin prick test, antigen specific IgE antibodies in blood, basophil histamine release test, elimination diet test, oral food challenge test, etc. Of these, the oral food challenge test is the most reliable. However, it should be conducted under the supervision of experienced physicians because it may cause adverse reactions such as anaphylaxis. © 2011 Japanese Society of Allergology.

Horita N.,Yokohama City University | Yomota M.,The Fraternity Memorial Hospital | Sasaki M.,Hasegawa Hospital | Morita S.,Yokohama City University | And 3 more authors.
Clinical Respiratory Journal | Year: 2014

Objective: The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is a quality-of-life (QOL) questionnaire that proved to correlate with St. George's Respiratory Questionnaire. Correlations between CAT scores and other COPD parameters have not been thoroughly evaluated in Japanese outpatients. Methods: Cross-sectional study of 85 outpatients with COPD at a Japanese community-based hospital. Patients: We observed 70 men and 15 women, whose average age was 72.0±9.0 years. Mean forced expiratory volume in 1s (FEV1) (% predicted) was 45.8±14.7%. Mean CAT score was 10.1±7.9 (range: 0-31). We calculated Spearman's rank correlation coefficient for CAT score and the following variables: r=0.81 for 'the Body Mass Index, Airflow Obstruction, Dyspnea and Exercise Capacity Index'; r=-0.05 for body mass index; r=-0.56 for FEV1 (% predicted); r=0.88 for Modified Medical Research Council Dyspnea Scale; r=-0.71 for 6-min walk distance; r=0.68 for 'the Age, Dyspnoea,and Airflow Obstruction Index'; and r=-0.40 for oxygen saturation in artery. Each COPD parameter, except for body mass index, had a significant (P<0.001) correlation with the CAT score. Conclusions: The CAT score, which is obtainable by a simple questionnaire originally designed for QOL assessment, had strong correlations with airflow obstruction, dyspnea, exercise tolerance, prognostic index and oxygenation in Japanese outpatients. © 2013 John Wiley & Sons Ltd.

Horita N.,The Fraternity Memorial Hospital | To M.,The Fraternity Memorial Hospital | To M.,Dokkyo Medical University | Araki K.,The Fraternity Memorial Hospital | And 2 more authors.
Allergology International | Year: 2012

Background: Single inhaled corticosteroids and long-acting beta-agonists (ICS/LABA) are clinically effective and safe. However, if local oropharyngeal and laryngeal adverse effects (LOLAE) appear, adherence to the use of ICS is impaired. To minimize the development of adverse effects, it is essential to identify the underlying risk factors. Methods: The study included 481 asthmatic patients who were prescribed ICS/LABA for the first time in their life between January and September of 2010. Patients ranged in age from 14 to 86 years old and consisted of 281 never smokers and 200 smokers. All data were collected retrospectively by respirologists. Results: Seventy-three out of 481 patients suffered from one or more adverse effects, with 54 of these exhibiting LOLAE. Patients with LOLAE (51.4 ± 16.2 yrs) were significantly older than those without LOLAE (43.7 ± 15.9 yrs) (p = 0.0011) and were also prescribed a significantly higher dose of ICS. The pack-years of patients with LOLAE (2.1 ± 4.9) were significantly lower than those without LOLAE (6.0 ± 13.0) (p = 0.0087). The type of administered ICS was also significantly associated with a risk of developing LOLAE. Conclusions: Our survey indicated that a greater age, a higher dose of ICS, and the type of ICS were potential risk factors of LOLAE. The identified factors should be considered in a clinical setting in order to prevent the development of LOLAE and provide optimal treatment to patients. © 2012 Japanese Society of Allergology.

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