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1.
NPJ Prim Care Respir Med ; 30(1): 35, 2020 08 04.
Artigo em Inglês | MEDLINE | ID: mdl-32753647

RESUMO

There is an ongoing debate about the benefit-risk balance of systemic corticosteroids (SCS) in asthma treatment. We investigated the associations between SCS use and disease burden in a database cohort of asthmatics, categorized into SCS and non-SCS prescription at baseline and quartiles (Q) by cumulative SCS dosage. Of the 10,579 patients, the SCS cohort comprised 3103 patients (29.3%). Mean SCS dosages at baseline were 0.08, 0.29, 0.79, and 4.58 mg/day in Q1, Q2, Q3, and Q4, respectively. Similar SCS dosages were used within each quartile throughout the study period. No remarkable changes in asthma severity or control status were observed. All SCS cohorts had a higher risk of intermittent SCS exposure during the observation period. SCS use was associated with osteoporosis, diabetes, anxiety/neurosis, and depression. SCS-dependent treatment does not necessarily lead to the future improvement of asthma control; rather, it may negatively impact systemic health, even at mean dosages <5 mg/day.


Assuntos
Corticosteroides/uso terapêutico , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Efeitos Psicossociais da Doença , Corticosteroides/administração & dosagem , Antiasmáticos/administração & dosagem , Asma/economia , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Índice de Gravidade de Doença
2.
J Allergy Clin Immunol Pract ; 8(2): 710-720.e14, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31541768

RESUMO

BACKGROUND: The standardized quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT) tablet has demonstrated efficacy and safety for allergic asthma (AA) in European trials. OBJECTIVE: To evaluate the efficacy and safety of SQ HDM SLIT tablet treatment for up to 19 months in Japanese adults with AA. METHODS: In this randomized, double-blind, placebo-controlled trial, patients aged 18 to 64 years with AA were randomly assigned (1:1:1) to SQ HDM SLIT doses of 10,000 or 20,000 Japanese Allergy Unit or placebo. Subjects had Asthma Control Questionnaire score of 1.0 to 1.5 and daily inhaled corticosteroid use of 200 to 400 µg of fluticasone propionate at randomization. The primary end point was the time from randomization to the first asthma exacerbation as the inhaled corticosteroid dose was being reduced. RESULTS: Of the 826 randomized subjects, 693 (84%) completed the trial. No statistically significant differences between the active groups and the placebo group were observed for the primary or any other efficacy end points. However, post hoc analysis indicated a significant difference between the 20,000 Japanese Allergy Unit and placebo groups among subjects who used a short-acting ß2-agonist during the baseline period (hazard ratio, 0.70; 95% CI, 0.48-1.00; P = .04997). No deaths or anaphylactic reactions were reported. Most adverse events were mild to moderate in severity. CONCLUSIONS: The trial demonstrated a favorable safety profile of the SQ HDM SLIT tablet in Japanese adult patients with AA. The treatment appeared to be efficacious in patients requiring rescue medication (ie, short-acting ß2-agonist) at baseline in the efficacy assessment using asthma exacerbation during inhaled corticosteroid reduction (JapicCTI number 121847).


Assuntos
Asma , Imunoterapia Sublingual , Adolescente , Adulto , Animais , Antígenos de Dermatophagoides , Asma/tratamento farmacológico , Método Duplo-Cego , Humanos , Japão , Pessoa de Meia-Idade , Pyroglyphidae , Comprimidos , Resultado do Tratamento , Adulto Jovem
3.
Allergol Int ; 69(1): 53-60, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31311707

RESUMO

BACKGROUND: The severe asthma and severe, uncontrolled asthma (SUA) populations in Japan are not well-studied. We investigated the prevalence of continuously treated severe asthma and SUA patients, their disease burden, and the treatment reality via a Japanese health insurance claims database. METHODS: Continuously treated asthma patients (patients prescribed inhaled corticosteroids for asthma ≥4 times in the past year) aged ≥17 years at the index date (latest visit between April 2014 and March 2015 for asthma treatment) were included in this analysis (KEIFU study, UMIN000027695). Asthma severity and control status at the index date were defined using modified criteria of ERS/ATS guidelines. Asthma hospitalization, oral corticosteroid (OCS) use, and total medical expenses were calculated using data up to 12 months post-index date. RESULTS: We identified 10,579 patients as continuously treated asthma patients. Of these, 823 (7.8%) had severe asthma; 267 (2.5%) and 556 (5.3%) patients had SUA and severe, controlled asthma (SCA), respectively. Compared with SCA and mild to moderate asthma patients, a greater percentage of SUA patients required hospitalization (13.7%, 6.2%, and 3.0%, respectively) and were prescribed OCSs (67.4%, 45.9%, and 16.2%, respectively). Yearly total medical expenses were also greater for SUA patients (mean [standard deviation]: 8346 [12,280], vs 5989 [10,483] and 3422 [8800] USD, respectively). CONCLUSIONS: The percentages of severe asthma and SUA patients continuously treated in Japan were obtained through this large-scale analysis using a health insurance claims database. SUA patients had greater medical and economic burdens, suggesting more appropriate treatment is required according to the treatment guidelines.


Assuntos
Corticosteroides/uso terapêutico , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Asma/epidemiologia , Efeitos Psicossociais da Doença , Adulto , Idoso , Asma/economia , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Prevalência
5.
Allergol Int ; 68(4): 470-477, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31178331

RESUMO

BACKGROUND: The comorbidity of asthma and allergic rhinitis is remarkably high, but not much is known about the effects of this combined condition on the quality of life. We aimed to evaluate the factors associated with asthma exacerbations and the effect of the exacerbations on the quality of life (QOL) through a one-year, large-scale, observational study in Japanese patients with asthma and rhinitis. METHODS: A case survey by attending physicians and a patient survey was conducted at each assessment timepoint over a period of one year. Patients were divided into two groups according to the presence or absence of asthmatic attacks after enrollment and were matched using propensity scores to evaluate the factors associated with asthma exacerbations and the effect of the exacerbation on QOL. RESULTS: Potential factors associated with asthma exacerbations included high body mass index value, low forced expiratory flow 75% of forced vital capacity (FEF75%), severe rhinitis as determined based on ARIA (Allergic Rhinitis and its Impact on Asthma). Although patients with asthma exacerbations had significantly impaired quality of life at baseline as evidenced by the economic aspects, in addition to physical, mental, and social activities, no further reduction with the attacks was observed. CONCLUSIONS: This study suggested that higher body mass index (BMI) and severe asthma as well as severe rhinitis were factors associated with asthma exacerbations. Although patients with asthma exacerbations had impaired QOL, attacks caused no further reduction.


Assuntos
Asma/complicações , Asma/epidemiologia , Qualidade de Vida , Rinite/complicações , Rinite/epidemiologia , Adulto , Idoso , Assistência Ambulatorial , Asma/diagnóstico , Progressão da Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Testes de Função Respiratória , Rinite/diagnóstico
6.
J Asthma ; 56(9): 1016-1025, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30252543

RESUMO

Objective: The level of asthma control in adult asthma patients receiving treatment in clinical practice from allergy and/or respiratory specialists in Japan remains unclear. We conducted the ACQUIRE-2 study (NCT02640742) to evaluate level of asthma control, asthma symptoms, health-related quality of life (HR-QoL), and reliever medication use in this setting. Methods: This observational study was undertaken between December 2015 and June 2016 in 58 medical institutions across Japan. We enrolled outpatients aged ≥20 years diagnosed with asthma for ≥1 year who were being managed by specialists. Criteria to evaluate the level of asthma control were based on modified definitions of the Asthma Prevention and Management Guideline 2015, Japan (JGL 2015) and Global Initiative for Asthma (GINA) 2012. Asthma symptoms, HR-QoL, and reliever medication use were also evaluated. Results: Of 1250 enrolled patients, 1175 were analyzed, 62.9% of whom were women. Mean (± standard deviation) age and duration of asthma were 59.7 ± 14.5 years and 16.9 ± 14.0 years, respectively. Using JGL 2015-based criteria, 24.4%, 69.2%, and 6.5% of patients had well-controlled, insufficiently-controlled, and poorly-controlled asthma, respectively. Using GINA-based criteria, 35.1%, 49.8%, and 15.1% of patients had controlled, partly controlled, and uncontrolled asthma, respectively. Daytime and nighttime asthma symptoms were experienced by 51.5% and 44.9% of patients, respectively. The mean MiniAQLQ score was 5.8 ± 1.0 (7-point scale). Conclusions: Asthma was not well-controlled in the majority of patients in this study. To achieve better asthma control, improvements in symptom monitoring and management may be required.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Qualidade de Vida , Idoso , Asma/complicações , Asma/diagnóstico , Asma/psicologia , Estudos Transversais , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Inquéritos e Questionários/estatística & dados numéricos
7.
Respir Med ; 141: 56-63, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-30053973

RESUMO

BACKGROUND: Omalizumab (anti-IgE monoclonal antibody) is an approved add-on therapy for Japanese patients with severe allergic asthma. As directed by the Ministry of Health, Labor and Welfare Japan, a post-marketing surveillance (PMS) study on omalizumab was conducted between 2009 and 2017. METHODS: The PMS observed safety and efficacy of omalizumab in patients treated with open-label omalizumab for 52 weeks (with optional 2-year extension period). Primary safety outcomes included incidence and severity of adverse events (AEs) and adverse drug reactions (ADRs). Primary efficacy outcomes included physician-assessed global evaluation of treatment effectiveness (GETE). Asthma-exacerbation-related events including requirement for additional systemic steroid therapy, hospitalization, emergency room visits, unscheduled doctor visits, and absenteeism were also evaluated. RESULTS: Of 3893 patients registered, 3620 (age [mean ±â€¯SD] 59.3 ±â€¯16.11 years) were evaluated for 52 weeks; 44.12% were aged ≥65 years and 64.45% were women. Overall, 32.24% reported AEs and 15.30% reported serious AEs. ADRs were seen in 292 (8.07%) patients. GETE results showed that the majority of patients experienced clinical improvements (58.29% at 16 weeks and 62.40% at 52 weeks). Nearly half of all patients (47.96%) were free from asthma exacerbations after therapy. Omalizumab also reduced all events related to asthma exacerbations. No specific ADRs were observed in the elderly population. CONCLUSIONS: This post-marketing study confirmed the clinically meaningful benefits of omalizumab in a majority of patients from Japan, and showed safety and efficacy in a real-life clinical setting to be consistent with previous reports.


Assuntos
Antiasmáticos/farmacologia , Asma/tratamento farmacológico , Marketing/métodos , Omalizumab/farmacologia , Adulto , Idoso , Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/imunologia , Progressão da Doença , Feminino , Humanos , Hipersensibilidade , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Omalizumab/administração & dosagem , Omalizumab/efeitos adversos , Estudos Prospectivos , Índice de Gravidade de Doença , Resultado do Tratamento
8.
Allergol Int ; 67(2): 266-272, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29128192

RESUMO

BACKGROUND: In the Phase III CALIMA trial, benralizumab significantly reduced asthma exacerbations, increased lung function, and alleviated symptoms for patients with severe, uncontrolled eosinophilic asthma. The aim of this subgroup analysis was to evaluate the efficacy and safety of benralizumab for Japanese patients in the CALIMA trial. METHODS: CALIMA was a randomised, controlled trial of 1306 patients (aged 12-75 years; registered at ClinicalTrials.gov: NCT01914757) with severe asthma uncontrolled by medium- to high-dosage inhaled corticosteroids and long-acting ß2-agonists (ICS/LABA). Patients received 56 weeks' benralizumab 30 mg either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses Q4W), or placebo Q4W. The primary analysis population was patients receiving high-dosage ICS/LABA with blood eosinophils ≥300 cells/µL. This subgroup analysis covered Japanese patients from this group. RESULTS: Of 83 patients randomised in Japan, 46 were receiving high-dosage ICS/LABA and had blood eosinophils ≥300 cells/µL. Compared with placebo, benralizumab reduced the annual rate of asthma exacerbations by 66% (Q4W; rate ratio 0.34, 95% CI, 0.11-0.99) and 83% (Q8W; rate ratio 0.17, 95% CI, 0.05-0.60); increased prebronchodilator FEV1 by 0.334 L (Q4W; 95% CI, 0.020-0.647) and 0.198 L (Q8W; 95% CI, -0.118 to 0.514); and decreased total asthma symptom score by 0.17 (Q4W; 95% CI, -0.82 to 0.48) and 0.24 (Q8W; 95% CI, -0.87 to 0.40). Percentages of adverse events were consistent with the overall CALIMA group. CONCLUSIONS: Benralizumab reduced annual asthma exacerbations and symptoms, increased lung function, and was well-tolerated by Japanese patients with severe, uncontrolled eosinophilic asthma.


Assuntos
Antiasmáticos/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/tratamento farmacológico , Adolescente , Adulto , Idoso , Povo Asiático , Asma/imunologia , Criança , Eosinófilos/efeitos dos fármacos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
9.
BMC Pulm Med ; 17(1): 153, 2017 Nov 23.
Artigo em Inglês | MEDLINE | ID: mdl-29169365

RESUMO

BACKGROUND: Despite recognition of asthma as a growing global issue and development of global guidelines, asthma treatment practices vary between countries. Several studies have reported patients' perspectives on asthma control. This study presents physicians' perspectives and strategies for asthma management. METHODS: Physicians seeing ≥4 adult patients with asthma per month in Australia, Canada, China, France, Germany, and Japan were surveyed (N=1809; ≈300 per country). A standardised questionnaire was developed for this study and administered by telephone, online or face-to-face. Statistics were weighted to account for the sampling scheme. RESULTS: Physicians estimated that 71% of their adult patients received maintenance medication, with adherence monitored by 76-97% of physicians. Perceived major barriers to patient adherence included: patients taking treatment as needed; acceptance of symptoms; and patients not perceiving treatment benefits. Written action plans (37%) and technology (15%) were seldom employed by physicians to aid patients' asthma management. Physicians rarely (10%) used validated patient-reported questionnaires to monitor asthma control, instead monitoring selected symptoms, exacerbations, and/or lung function measurements. Awareness of single maintenance and reliever therapy (SMART/MART) varied among countries (56-100%); although most physicians (72%) had prescribed SMART/MART, the majority (91%) co-prescribed a short-acting bronchodilator at least some of the time. CONCLUSIONS: These results show that physicians generally do not employ standardised tools to monitor asthma control or to manage its treatment and that despite high awareness of SMART/MART, the strategy appears to be commonly misapplied. Better education for patients and physicians is required to improve asthma management and resulting patient outcomes.


Assuntos
Asma/terapia , Gerenciamento Clínico , Fidelidade a Diretrizes , Cooperação do Paciente , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Idoso , Estudos Transversais , Feminino , Humanos , Internacionalidade , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários
11.
Respir Med ; 120: 78-86, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27817819

RESUMO

BACKGROUND: For patients with well-controlled asthma, 'step down' of therapy is recommended. We evaluated Japanese patients switching from inhaled corticosteroid (ICS)/long-acting beta2-agonists (LABA; equivalent to fluticasone propionate [FP]/salmeterol [SAL] 250/50 µg twice daily [BD]) to fluticasone furoate (FF)/vilanterol (VI) 100/25 µg, then stepping down to ICS alone. METHODS: This phase III trial had two treatment periods (P): P1, patients with well-controlled asthma on FP/SAL 250/50 µg BD equivalent stepped across to once daily (OD) FF/VI 100/25 µg (open-label, eight weeks); P2, patients remaining 'well controlled' after P1 stepped down to FF 100 µg OD/FP 100 µg BD/FP 250 µg BD (randomized 1:1:1, double-blind, 12 weeks). Co-primary P2 endpoints: percentage of patients with well-controlled asthma; time to withdrawal due to poorly controlled asthma requiring step-up therapy. Adverse events (AEs) were monitored. RESULTS: At the end of P1 (n = 430), 373 (90.5%; 95% confidence interval 87.29-93.18) patients' asthma remained well controlled with FF/VI; in P2 (n = 371), control was maintained in 89.5% (FF 100 µg)/79.5% (FP 100 µg)/83.8% (FP 250 µg) of patients. In P2, 4.9-7.3% of patients were withdrawn due to worsening asthma (time-to-withdrawal cumulative incidence curves were comparable). AEs were reported by 37% of patients during P1; and by 36% (FF 100 µg)/48% (FP 100 µg)/49% (FP 250 µg) of patients in P2. CONCLUSIONS: For patients with well-controlled asthma on mid dose ICS/LABA (equivalent to FP/SAL 250/50 µg BD), control can be maintained when they are stepped across to FF/VI 100/25 µg OD. FF 100 µg OD is an effective step-down therapy from FF/VI 100/25 µg OD with similar efficacy to FP 100 µg BD and FP 250 µg BD.


Assuntos
Corticosteroides/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Androstadienos/administração & dosagem , Asma/tratamento farmacológico , Álcoois Benzílicos/administração & dosagem , Clorobenzenos/administração & dosagem , Combinação Fluticasona-Salmeterol/administração & dosagem , Fluticasona/administração & dosagem , Administração por Inalação , Corticosteroides/farmacologia , Agonistas de Receptores Adrenérgicos beta 2/farmacologia , Adulto , Androstadienos/farmacologia , Androstadienos/uso terapêutico , Álcoois Benzílicos/uso terapêutico , Clorobenzenos/uso terapêutico , Combinação de Medicamentos , Feminino , Fluticasona/farmacologia , Combinação Fluticasona-Salmeterol/uso terapêutico , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Pico do Fluxo Expiratório/efeitos dos fármacos , Prevalência , Fumar/epidemiologia , Resultado do Tratamento
12.
Int Arch Allergy Immunol ; 169(3): 135-45, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27097165

RESUMO

BACKGROUND: Airway eosinophils are considered to play an important role in the pathogenesis of asthma. Interleukin-5 is believed to be a key cytokine for the development, proliferation and activation of eosinophils. Benralizumab is an anti-interleukin-5 receptor α monoclonal antibody that depletes blood and airway eosinophils. We conducted a phase 2a study in South Korea and Japan to evaluate the effect of benralizumab in an East Asian population. The primary objective was to evaluate the effect of benralizumab in adults with uncontrolled eosinophilic asthma with 2-6 incidences of exacerbations in the past year using a medium/high dose of inhaled corticosteroids and long-acting ß2-agonists. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. The subjects (n = 106) were randomized into four groups: placebo (n = 27) or benralizumab 2 mg (n = 27), 20 mg (n = 26) and 100 mg (n = 26). Benralizumab or placebo were administered subcutaneously on weeks 0 (day 1), 4, 8, 16, 24, 32 and 40. The primary endpoint was the asthma exacerbation rate at week 52. RESULTS: The asthma exacerbation rate was reduced by 33, 45 or 36% versus the placebo group when treated with 2, 20 or 100 mg of benralizumab, respectively. The percent mean change in forced expiratory volume at 1 s increased with each of the three doses in subjects treated with benralizumab. CONCLUSIONS: Benralizumab reduced asthma exacerbation and improved lung function and asthma control in adults with uncontrolled eosinophilic asthma.


Assuntos
Antiasmáticos/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Asma/diagnóstico , Asma/tratamento farmacológico , Eosinófilos/patologia , Escarro , Idoso , Idoso de 80 Anos ou mais , Antiasmáticos/administração & dosagem , Antiasmáticos/efeitos adversos , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Biomarcadores , Progressão da Doença , Eosinófilos/efeitos dos fármacos , Eosinófilos/imunologia , Eosinófilos/metabolismo , Feminino , Humanos , Japão , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Receptores de Interleucina-5/antagonistas & inibidores , República da Coreia , Testes de Função Respiratória , Escarro/citologia , Resultado do Tratamento
13.
J Microbiol Immunol Infect ; 49(3): 459-63, 2016 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24291616

RESUMO

Allergic bronchopulmonary aspergillosis (ABPA) is a severe type of asthma. Some cases are resistant to treatment, even with regular use of antiasthmatic drugs and antifungal agents. The diagnosis of ABPA was made in a 40-year-old patient with ABPA according to the Rosenberg-Patterson criteria. Symptoms were not controlled despite regular use of antiasthmatic drugs, daily systemic steroids, and antifungal agents. Omalizumab, administered in an attempt to stabilize these uncontrolled symptoms, was effective with no adverse events. Our experience suggests omalizumab is a potential candidate drug for controlling steroid-dependent ABPA.


Assuntos
Antiasmáticos/uso terapêutico , Anticorpos Anti-Idiotípicos/uso terapêutico , Aspergilose Broncopulmonar Alérgica/tratamento farmacológico , Imunoterapia/métodos , Omalizumab/uso terapêutico , Adolescente , Adulto , Antifúngicos/uso terapêutico , Aspergilose Broncopulmonar Alérgica/imunologia , Aspergilose Broncopulmonar Alérgica/microbiologia , Aspergillus fumigatus/efeitos dos fármacos , Aspergillus fumigatus/imunologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
14.
PLoS One ; 10(4): e0124109, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25894430

RESUMO

BACKGROUND: This study assessed the long-term safety and efficacy of tiotropium Respimat, a long-acting inhaled anticholinergic bronchodilator, in asthma, added on to inhaled corticosteroids (ICS) with or without long-acting ß2-agonist (LABA). METHODS: 285 patients with symptomatic asthma, despite treatment with ICS±LABA, were randomised 2:2:1 to once-daily tiotropium 5 µg, tiotropium 2.5 µg or placebo for 52 weeks (via the Respimat SoftMist inhaler) added on to ICS±LABA, in a double-blind, placebo-controlled, parallel-group study (NCT01340209). PRIMARY OBJECTIVE: to describe the long-term safety profile of tiotropium. Secondary end points included: trough forced expiratory volume in 1 second (FEV1) response; peak expiratory flow rate (PEFR) response; seven-question Asthma Control Questionnaire (ACQ-7) score. RESULTS: At Week 52, adverse-event (AE) rates with tiotropium 5 µg, 2.5 µg and placebo were 88.6%, 86.8% and 89.5%, respectively. Commonly reported AEs with tiotropium 5 µg, 2.5 µg and placebo were nasopharyngitis (48.2%, 44.7%, 42.1%), asthma (28.9%, 29.8%, 38.6%), decreased PEFR (15.8%, 7.9%, 21.1%), bronchitis (9.6%, 13.2%, 7.0%), pharyngitis (7.9%, 13.2%, 3.5%) and gastroenteritis (10.5%, 3.5%, 5.3%). In the tiotropium 5 µg, 2.5 µg and placebo groups, 8.8%, 5.3% and 5.3% of patients reported drug-related AEs; 3.5%, 3.5% and 15.8% reported serious AEs. Asthma worsening was the only serious AE reported in more than one patient. At Week 52, adjusted mean trough FEV1 and trough PEFR responses were significantly higher with tiotropium 5 µg (but not 2.5 µg) versus placebo. ACQ-7 responder rates were higher with tiotropium 5 µg and 2.5 µg versus placebo at Week 24. CONCLUSIONS: The long-term tiotropium Respimat safety profile was comparable with that of placebo Respimat, and associated with mild to moderate, non-serious AEs in patients with symptomatic asthma despite ICS±LABA therapy. Compared with placebo, tiotropium 5 µg, but not 2.5 µg, significantly improved lung function and symptoms, supporting the long-term efficacy of the 5 µg dose. TRIAL REGISTRATION: ClinicalTrials.gov NCT01340209.


Assuntos
Corticosteroides/administração & dosagem , Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Asma/tratamento farmacológico , Antagonistas Colinérgicos/administração & dosagem , Brometo de Tiotrópio/administração & dosagem , Administração por Inalação , Adolescente , Adulto , Idoso , Broncodilatadores , Método Duplo-Cego , Esquema de Medicação , Feminino , Volume Expiratório Forçado , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Nebulizadores e Vaporizadores , Pico do Fluxo Expiratório , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
15.
Int Arch Allergy Immunol ; 168(3): 165-72, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26790100

RESUMO

BACKGROUND: Omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, inhibits the binding of circulating IgE to mast cells and basophils, resulting in fewer episodes of airway inflammation, asthma symptoms and exacerbations in patients with severe allergic asthma. Treatment of patients with asthma using omalizumab increases serum total IgE (tIgE) levels. However, little is known about the influence of omalizumab on allergen-specific IgE (sIgE). METHODS: tIgE and sIgE in 47 adult patients with severe asthma were measured with a fluorescent enzyme immunoassay (ImmunoCAP-FEIA) before and after omalizumab treatment. RESULTS: Treatment with omalizumab increased tIgE and sIgE levels. The increases in sIgE by class category after omalizumab treatment were positively correlated with baseline sIgE positivity before treatment. The mean changes in sIgE levels after omalizumab treatment were also correlated with baseline sIgE levels before treatment. The mean changes in tIgE levels were positively correlated with the mean changes in IgE levels against Dermatophagoides pteronyssinus, crude house dust, Japanese cedar and moth. Omalizumab markedly influenced the negative-to-positive seroconversion rate for IgE against Japanese cedar (30.8%), Candida (29.0%) and moth (28.0%). Finally, all patients with negative-to-positive seroconversion for Japanese cedar-specific IgE had cedar pollinosis before beginning omalizumab treatment. CONCLUSIONS: The changes in sIgE levels after omalizumab treatment may be dependent on the baseline sIgE levels. Our data may indicate the presence of undetectable but functional sIgE.


Assuntos
Alérgenos/imunologia , Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Imunoglobulina E/sangue , Omalizumab/uso terapêutico , Adulto , Idoso , Asma/imunologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
16.
Respir Res ; 15: 144, 2014 Nov 20.
Artigo em Inglês | MEDLINE | ID: mdl-25409901

RESUMO

BACKGROUND: Immunoglobulin (Ig) E is well-known to play a critical role in allergic diseases. We investigated the association between longitudinal change in total IgE level and the asthma control in patients with adult asthma. METHODS: For this retrospective study, 154 patients with asthma aged 21-82 years were recruited from the allergy and pulmonary units of the Showa University Hospital. Data on longitudinal changes in IgE over the preceding 10 years were collected and logarithmically transformed. Associations between longitudinal change in IgE and clinical characteristics including asthma control test (ACT) score, asthma control, pulmonary function test, and antigen specific IgE, were assessed. RESULTS: Patients with increased IgE tended to have significantly higher mean age, more episodes of acute exacerbation within a year, lower ACT scores, and used oral corticosteroids more frequently than those with decreased or unchanged IgE. The prevalence of uncontrolled asthma was higher in patients with increased IgE than in those with decreased or unchanged IgE. Mean %FEV1 and FEV1% were lower in patients with increased IgE than in those with decreased or unchanged IgE. Moreover, the prevalence of Aspergillus-specific IgE was higher in patients with increased IgE than in those with decreased or unchanged IgE. CONCLUSIONS: These data suggest that a longitudinal increase in total IgE is associated with both poor asthma control and Aspergillus-specific IgE in patients with adult asthma.


Assuntos
Asma/imunologia , Imunoglobulina E/sangue , Pulmão/imunologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiasmáticos/uso terapêutico , Aspergillus/imunologia , Asma/tratamento farmacológico , Asma/epidemiologia , Asma/microbiologia , Asma/fisiopatologia , Biomarcadores/sangue , Progressão da Doença , Feminino , Volume Expiratório Forçado , Humanos , Japão/epidemiologia , Estudos Longitudinais , Pulmão/efeitos dos fármacos , Pulmão/microbiologia , Pulmão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Prevalência , Testes de Função Respiratória , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Regulação para Cima , Adulto Jovem
17.
Allergol Int ; 63(3): 293-333, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25178175

RESUMO

Adult bronchial asthma (hereinafter, asthma) is characterized by chronic airway inflammation, reversible airway narrowing, and airway hyperresponsiveness. Long-standing asthma induces airway remodeling to cause intractable asthma. The number of patients with asthma has increased, and that of patients who die from asthma has decreased (1.5 per 100,000 patients in 2012). The aim of asthma treatment is to enable patients with asthma to lead a normal life without any symptoms. A good relationship between physicians and patients is indispensable for appropriate treatment. Long-term management with antiasthmatic agents and elimination of the causes and risk factors of asthma are fundamental to its treatment. Four steps in pharmacotherapy differentiate between mild and intensive treatments; each step includes an appropriate daily dose of an inhaled corticosteroid, varying from low to high. Long-acting ß2-agonists, leukotriene receptor antagonists, and sustained-release theophylline are recommended as concomitant drugs, while anti-immunoglobulin E antibody therapy has been recently developed for the most severe and persistent asthma involving allergic reactions. Inhaled ß2-agonists, aminophylline, corticosteroids, adrenaline, oxygen therapy, and others are used as needed in acute exacerbations by choosing treatment steps for asthma exacerbations depending on the severity of attacks. Allergic rhinitis, chronic obstructive pulmonary disease, aspirin-induced asthma, pregnancy, asthma in athletes, and cough-variant asthma are also important issues that need to be considered.


Assuntos
Corticosteroides/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Asma/terapia , Antagonistas de Leucotrienos/uso terapêutico , Guias de Prática Clínica como Assunto , Adulto , Humanos , Oxigenoterapia Hiperbárica , Imunoglobulina E/imunologia , Japão , Teofilina/uso terapêutico
18.
Arerugi ; 63(2): 178-86, 2014 Feb.
Artigo em Japonês | MEDLINE | ID: mdl-24714183

RESUMO

BACKGROUND: The "zero death from asthma strategy" in the medical treatment for bronchial asthma has been promoted by the Ministry of Health, Labour, and Welfare from 2006, and it indicates that medical and non-medical specialists, as well as pharmacists, should cooperate, and strives to build cooperation which is suited the actual conditions of an area. It is also important for COPD. Although hospitals in some areas cooperate with clinics and pharmacies, the overall concept of cooperation appears to be absent in most Japanese hospitals. METHOD: A questionnaire was administered in early March, 2012 to 477 allergology institutions, and was authorized by an educational establishment. RESULT: Among 246 replies from the institutions, cooperation between hospitals and clinics was carried out by 98 institutions (39.8%) specializing in bronchial asthma, and in 64 institutions (37.2%) specializing in COPD. However, cooperation tools were used in only 37 of these institutions (15.0%). The ability to fill prescriptions outside the hospital was available in 209 institutions (85.0%). One-hundred and seventeen institutions (47.6%) replied that they have no tools for hospital-pharmacy cooperation. Direct indications were written in prescriptions by 82 institutions (33.3). CONCLUSION: In order to build inter-regional association and to equalize medical treatment, we suggest that developing tools and organization for cooperation between health professionals who treat patients with bronchial asthma and COPD is necessary.


Assuntos
Instituições de Assistência Ambulatorial , Asma/tratamento farmacológico , Hospitais , Comunicação Interdisciplinar , Farmácia , Administração por Inalação , Antiasmáticos/administração & dosagem , Asma/mortalidade , Humanos , Japão/epidemiologia , Educação de Pacientes como Assunto/estatística & dados numéricos , Prescrições/estatística & dados numéricos , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Inquéritos e Questionários
19.
Allergol Int ; 63(3): 293-333, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-28942927

RESUMO

Adult bronchial asthma (hereinafter, asthma) is characterized by chronic airway inflammation, reversible airway narrowing, and airway hyperresponsiveness. Long-standing asthma induces airway remodeling to cause intractable asthma. The number of patients with asthma has increased, and that of patients who die from asthma has decreased (1.5 per 100,000 patients in 2012). The aim of asthma treatment is to enable patients with asthma to lead a normal life without any symptoms. A good relationship between physicians and patients is indispensable for appropriate treatment. Long-term management with antiasthmatic agents and elimination of the causes and risk factors of asthma are fundamental to its treatment. Four steps in pharmacotherapy differentiate between mild and intensive treatments; each step includes an appropriate daily dose of an inhaled corticosteroid, varying from low to high. Long-acting 02-agonists, leukotriene receptor antagonists, and sustained-release theophylline are recommended as concomitant drugs, while anti-immunoglobulin E antibody therapy has been recently developed for the most severe and persistent asthma involving allergic reactions. Inhaled 02-agonists, aminophylline, corticosteroids, adrenaline, oxygen therapy, and others are used as needed in acute exacerbations by choosing treatment steps for asthma exacerbations depending on the severity of attacks. Allergic rhinitis, chronic obstructive pulmonary disease, aspirin-induced asthma, pregnancy, asthma in athletes, and coughvariant asthma are also important issues that need to be considered.

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