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[PMID]:28258535
[Au] Autor:Scichilone N; Braido F; Lavorini F; Levy ML; Usmani OS
[Ad] Endereço:Department of Biomedicine and Internal and Specialist Medicine, DIBIMIS, University of Palermo, via Trabucco 180, 90146, Palermo, Italy. nicola.scichilone@unipa.it.
[Ti] Título:Routine Use of Budesonide/Formoterol Fixed Dose Combination in Elderly Asthmatic Patients: Practical Considerations.
[So] Source:Drugs Aging;34(5):321-330, 2017 May.
[Is] ISSN:1179-1969
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:Asthma has been demonstrated to be as common in the elderly as in younger age groups. Although no specific recommendations exist to manage the disease differently in older individuals, functional features and clinical presentations may be affected by age per se, and by age-related conditions, such as comorbidities and polypharmacy. In this review article, we aimed to explore the efficacy and safety in elderly asthmatic patients of one of the most currently used inhaled treatments for asthma, that is, the fixed-dose combination of budesonide/formoterol. We attempted to address some practical questions that are relevant to the daily practice of clinicians. We focused on the efficacy and real-world effectiveness of inhaled corticosteroids and long-acting ß-adrenergic bronchodilators (ICS/LABA) as treatment in the elderly population, since data are extrapolated from younger populations. We investigated whether a maintenance and reliever therapy approach is more effective in the elderly as opposed to maintenance regimens, from both the general practitioner's and the pulmonologist's perspective. To address these questions, we scanned electronic databases (PubMed, MEDLINE, Embase, Scopus and Google Scholar) from the date of inception up to October 2016 with a cross-search using the following keywords: 'asthma', 'elderly', 'SMART therapy', 'MART therapy', 'Turbuhaler', and 'budesonide/formoterol'. The available literature on the topic confirms that when the age-associated changes are properly managed in clinical practice, asthma in older populations can be optimally controlled with inhaled treatment including ICS/LABA. This also applies for the budesonide/formoterol fixed combination, thus allowing for the maintenance and reliever therapy approach.
[Mh] Termos MeSH primário: Antiasmáticos/uso terapêutico
Asma/tratamento farmacológico
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
[Mh] Termos MeSH secundário: Administração por Inalação
Idoso
Antiasmáticos/administração & dosagem
Antiasmáticos/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Bases de Dados Factuais
Interações Medicamentosas
Seres Humanos
Meia-Idade
Guias de Prática Clínica como Assunto
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Anti-Asthmatic Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:171114
[Lr] Data última revisão:
171114
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170305
[St] Status:MEDLINE
[do] DOI:10.1007/s40266-017-0449-7


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[PMID]:28254655
[Au] Autor:Bagherisadeghi G; Larhrib EH; Chrystyn H
[Ad] Endereço:Department of Pharmacy, University of Huddersfield, Queensgate, Huddersfield, HD1 3DH, UK.
[Ti] Título:Real life dose emission characterization using COPD patient inhalation profiles when they inhaled using a fixed dose combination (FDC) of the medium strength Symbicort Turbuhaler .
[So] Source:Int J Pharm;522(1-2):137-146, 2017 Apr 30.
[Is] ISSN:1873-3476
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:The dose emitted from dry powder inhalers (DPI) is inhalation flow dependent and so varies with the peak inhalation flow (PIF) of a patient's inhalation maneuver (IM). Dose emission could also be affected by other IM parameters-the inhaled volume (V ) and the initial acceleration rate of the IM (ACIM). We have adapted the compendial method for in-vitro DPI determinations so that inhalation profiles replace the inhalation square profile generated by a vacuum pump. These real-life patient inhalation profiles were measured when 18 COPD patients inhaled through an empty placebo Symbicort Turbuhaler . They have been used to identify the dose emission characteristics from a fixed dosed combination of 200µg budesonide plus 6µg formoterol Turbuhaler . To isolate each inhalation parameter some profiles were modified to provide a further 9 profiles to study the influence of V and 27 to identify the effect of ACIM. The fine particle dose, total emitted dose and mass median aerodynamic diameter were significantly (p<0.05) influenced by PIF (p<0.05) whereas ACIM and V had only a small effect. The results show the value of this ex-vivo methodology to provide an insight into the dose that each patient would have inhaled during real-life use.
[Mh] Termos MeSH primário: Administração por Inalação
Aerossóis
Broncodilatadores/administração & dosagem
Broncodilatadores/uso terapêutico
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
[Mh] Termos MeSH secundário: Idoso
Algoritmos
Combinação de Medicamentos
Inaladores de Pó Seco
Feminino
Seres Humanos
Masculino
Meia-Idade
Tamanho da Partícula
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Aerosols); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Drug Combinations)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170816
[Lr] Data última revisão:
170816
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170304
[St] Status:MEDLINE


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[PMID]:28240689
[Au] Autor:Festic E; Carr GE; Cartin-Ceba R; Hinds RF; Banner-Goodspeed V; Bansal V; Asuni AT; Talmor D; Rajagopalan G; Frank RD; Gajic O; Matthay MA; Levitt JE
[Ad] Endereço:1Department of Critical Care, Mayo Clinic, Jacksonville, FL. 2Division of Pulmonary and Critical Care, Department of Medicine, University of Arizona, Tucson, AZ. 3Department of Critical Care, Mayo Clinic, Scottsdale, AZ. 4Division of Pulmonary and Critical Care, Department of Medicine, Mayo Clinic, Rochester, MN. 5Department of Anesthesia, Beth Israel Deaconess Medical Center, Boston, MA. 6Division of Pulmonary and Critical Care, Department of Medicine, Stanford University, Stanford, CA. 7Department of Immunology, Mayo Clinic, Rochester, MN. 8Department of Health-Science Research/Biostatistics, Mayo Clinic, Jacksonville, FL. 9Departments of Medicine and Anesthesia, Cardiovascular Research Institute, University of California, San Francisco, CA.
[Ti] Título:Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome.
[So] Source:Crit Care Med;45(5):798-805, 2017 May.
[Is] ISSN:1530-0293
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: Effective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to acute respiratory distress syndrome by reducing lung inflammation and enhancing alveolar fluid clearance. DESIGN: Double-blind, randomized clinical trial (ClinicalTrials.gov: NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the FIO2 (S/F) through day 5. We also analyzed categorical change in S/F by greater than 20%. Other outcomes included need for mechanical ventilation and development of acute respiratory distress syndrome. SETTING: Five academic centers in the United States. PATIENTS: Adult patients admitted through the emergency department at risk for acute respiratory distress syndrome. INTERVENTIONS: Aerosolized budesonide/formoterol versus placebo bid for up to 5 days. MEASUREMENTS AND MAIN RESULTS: Sixty-one patients were enrolled from September 3, 2013, to June 9, 2015. Median time from presentation to first study drug was less than 9 hours. More patients in the control group had shock at enrollment (14 vs 3 patients). The longitudinal increase in S/F was greater in the treatment group (p = 0.02) and independent of shock (p = 0.04). Categorical change in S/F improved (p = 0.01) but not after adjustment for shock (p = 0.15). More patients in the placebo group developed acute respiratory distress syndrome (7 vs 0) and required mechanical ventilation (53% vs 21%). CONCLUSIONS: Early treatment with inhaled budesonide/formoterol in patients at risk for acute respiratory distress syndrome is feasible and improved oxygenation as assessed by S/F. These results support further study to test the efficacy of inhaled corticosteroids and beta agonists for prevention of acute respiratory distress syndrome.
[Mh] Termos MeSH primário: Corticosteroides/administração & dosagem
Agonistas Adrenérgicos beta/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Hipóxia/tratamento farmacológico
Síndrome do Desconforto Respiratório do Adulto/prevenção & controle
[Mh] Termos MeSH secundário: Centros Médicos Acadêmicos
Administração por Inalação
Idoso
Idoso de 80 Anos ou mais
Biomarcadores
Método Duplo-Cego
Quimioterapia Combinada
Feminino
Seres Humanos
Hipóxia/complicações
Masculino
Meia-Idade
Oxigênio/sangue
Gravidade do Paciente
Respiração Artificial
Síndrome do Desconforto Respiratório do Adulto/etiologia
Fatores de Risco
Estados Unidos
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Adrenergic beta-Agonists); 0 (Biomarkers); 0 (Budesonide, Formoterol Fumarate Drug Combination); S88TT14065 (Oxygen)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170509
[Lr] Data última revisão:
170509
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170228
[St] Status:MEDLINE
[do] DOI:10.1097/CCM.0000000000002284


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[PMID]:28031707
[Au] Autor:Calverley PM; Eriksson G; Jenkins CR; Anzueto AR; Make BJ; Persson A; Fagerås M; Postma DS
[Ad] Endereço:Pulmonary and Rehabilitation Research Group, University Hospital Aintree, Liverpool, UK.
[Ti] Título:Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD.
[So] Source:Int J Chron Obstruct Pulmon Dis;12:13-25, 2017.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND AND OBJECTIVE: Large clinical trials have confirmed the long-term efficacy of inhaled corticosteroid/long-acting ß -agonist combinations in patients with chronic obstructive pulmonary disease (COPD). It was hypothesized that significant treatment effects would already be present within 3 months after the initiation of treatment across a range of clinical outcomes, irrespective of COPD severity. METHODS: Post hoc analysis of 3-month post-randomization outcomes, including exacerbation rates, dropouts, symptoms, reliever use, and lung function, from three studies with similar inclusion criteria of moderate-to-very-severe COPD. Patients (n=1,571) were treated with budesonide/formoterol (B/F) 320/9 µg or placebo, twice daily; in one study, tiotropium 18 µg once daily was also given. RESULTS: Over the first 3 months of treatment, fewer patients randomized to B/F experienced exacerbations versus the placebo group (111 and 196 patients with ≥1 exacerbation, respectively). This was true in each COPD severity group. Compared with placebo, B/F treatment led to significantly lower 3-month exacerbation rates in the moderate and severe COPD severity groups (46% and 57% reduction, respectively), with a nonsignificant reduction (29%) in very severe COPD. Fewer dropouts occurred among patients treated with B/F versus placebo, this effect being greater with increasing COPD severity. B/F was associated with improved forced expiratory volume in 1 s, morning peak expiratory flow rate, total reliever use, and total symptom score versus placebo. CONCLUSION: Treatment with B/F decreased exacerbations in patients with moderate-to-very-severe COPD within 3 months of commencing treatment. This effect was paralleled by improved lung function, less reliever medication use, and fewer symptoms, irrespective of disease severity.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Broncodilatadores/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Glucocorticoides/administração & dosagem
Pulmão/efeitos dos fármacos
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Idoso
Broncodilatadores/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Progressão da Doença
Feminino
Volume Expiratório Forçado
Glucocorticoides/efeitos adversos
Seres Humanos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Pacientes Desistentes do Tratamento
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Recuperação de Função Fisiológica
Índice de Gravidade de Doença
Fatores de Tempo
Resultado do Tratamento
Capacidade Vital
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Glucocorticoids)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170823
[Lr] Data última revisão:
170823
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161230
[St] Status:MEDLINE
[do] DOI:10.2147/COPD.S114209


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[PMID]:27877031
[Au] Autor:Wang CY; Lai CC; Yang WC; Lin CC; Chen L; Wang HC; Yu CJ
[Ad] Endereço:Department of Internal Medicine; Medical Research Center, Cardinal Tien Hospital, Fu Jen Catholic University College of Medicine, New Taipei City.
[Ti] Título:The association between inhaled corticosteroid and pneumonia in COPD patients: the improvement of patients' life quality with COPD in Taiwan (IMPACT) study.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:2775-2783, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:To investigate the association between inhaled corticosteroid (ICS) exposure patterns and the risk of pneumonia in chronic obstructive pulmonary disease (COPD) patients, we performed a nested case-control study. Between 1998 and 2010, 51,739 patients, including 19,838 cases of pneumonia, were matched to 74,849 control subjects selected from a cohort of COPD patients using ICSs via risk-set sampling of the database constructed by the National Health Research Institutes of Taiwan. After adjusting for covariates, the current use of ICSs was associated with a 25% increase in the risk of pneumonia (odds ratio [OR] =1.25, 95% confidence interval [CI] =1.20-1.30), and there was an increase in the OR with increase in the average daily dosage. Additionally, users of fluticasone/salmeterol, fluticasone, and either fluticasone/salmeterol or fluticasone were more likely to be at a higher risk of pneumonia (OR =1.35, 95% CI =1.28-1.41; OR =1.22, 95% CI =1.10-1.35; and OR =1.33, 95% CI =1.27-1.39, respectively). In contrast, there were no statistically significant associations between the risk of pneumonia and the use of budesonide/formoterol, budesonide, or either budesonide/formoterol or budesonide. In conclusion, ICSs are significantly associated with an increased risk of pneumonia in COPD patients. The effect is prominent for fluticasone-containing ICSs but not for budesonide-containing ICSs.
[Mh] Termos MeSH primário: Corticosteroides/efeitos adversos
Broncodilatadores/efeitos adversos
Combinação Fluticasona-Salmeterol/efeitos adversos
Pulmão/efeitos dos fármacos
Pneumonia/induzido quimicamente
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
Qualidade de Vida
[Mh] Termos MeSH secundário: Administração por Inalação
Corticosteroides/administração & dosagem
Idoso
Idoso de 80 Anos ou mais
Broncodilatadores/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Estudos de Casos e Controles
Estudos Transversais
Bases de Dados Factuais
Feminino
Seres Humanos
Modelos Logísticos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Razão de Chances
Pneumonia/diagnóstico
Pneumonia/fisiopatologia
Pneumonia/psicologia
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Doença Pulmonar Obstrutiva Crônica/psicologia
Medição de Risco
Fatores de Risco
Taiwan
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Fluticasone-Salmeterol Drug Combination)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161124
[St] Status:MEDLINE


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[PMID]:27853362
[Au] Autor:Perrone V; Sangiorgi D; Buda S; Degli Esposti L
[Ad] Endereço:CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
[Ti] Título:Comparative analysis of budesonide/formoterol and fluticasone/salmeterol combinations in COPD patients: findings from a real-world analysis in an Italian setting.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:2749-2755, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:AIM: The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a "real-world" setting. The outcomes included exacerbation rates and health care costs. PATIENTS AND METHODS: An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting ß2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40 years and had at least 6 months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System. RESULTS: After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13 years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74-0.96, =0.010) for number of hospitalizations, 0.89 (95% CI: 0.87-0.92, <0.001) for number of oral corticosteroid prescriptions and 0.88 (95% CI: 0.86-0.89, <0.001) for number of antibiotic prescriptions. The mean annual expenditure for COPD management was €2,436 for patients treated with budesonide/formoterol and €2,784 for patients treated with fluticasone/salmeterol. CONCLUSION: Among patients with COPD, treatment with a fixed combination of budesonide/formoterol was associated with fewer exacerbations and a lower, but not significant, cost of illness than the treatment with fluticasone/salmeterol. Real-world analyses are requested to ameliorate interventions to address unmet needs, optimizing treatment pathways to improve COPD-related burden and outcomes.
[Mh] Termos MeSH primário: Agonistas de Receptores Adrenérgicos beta 2/uso terapêutico
Broncodilatadores/uso terapêutico
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
Combinação Fluticasona-Salmeterol/uso terapêutico
Glucocorticoides/uso terapêutico
Pulmão/efeitos dos fármacos
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Demandas Administrativas em Assistência à Saúde
Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Agonistas de Receptores Adrenérgicos beta 2/economia
Idoso
Broncodilatadores/efeitos adversos
Broncodilatadores/economia
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/economia
Análise Custo-Benefício
Bases de Dados Factuais
Progressão da Doença
Custos de Medicamentos
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Combinação Fluticasona-Salmeterol/economia
Glucocorticoides/efeitos adversos
Glucocorticoides/economia
Seres Humanos
Itália
Pulmão/fisiopatologia
Masculino
Meia-Idade
Pontuação de Propensão
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/economia
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Recuperação de Função Fisiológica
Estudos Retrospectivos
Fatores de Tempo
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Adrenergic beta-2 Receptor Agonists); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Glucocorticoids)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161118
[St] Status:MEDLINE


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Pizzichini, Emílio
PubMed Central Texto completo
Texto completo
[PMID]:27574416
[Au] Autor:Rennard SI; Martinez FJ; Rabe KF; Sethi S; Pizzichini E; McIvor A; Siddiqui S; Anzueto A; Zhu H
[Ad] Endereço:Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA; AstraZeneca, Cambridge, UK.
[Ti] Título:Effects of roflumilast in COPD patients receiving inhaled corticosteroid/long-acting ß2-agonist fixed-dose combination: RE(2)SPOND rationale and study design.
[So] Source:Int J Chron Obstruct Pulmon Dis;11:1921-8, 2016.
[Is] ISSN:1178-2005
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting ß2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein. METHODS: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within 12 months, and were receiving ICS/LABA FDC for ≥3 months. The primary efficacy measure is the rate of moderate or severe COPD exacerbations per participant per year. The secondary efficacy outcomes include mean change in prebronchodilator forced expiratory volume in 1 second (FEV1) over 52 weeks, rate of severe exacerbations, and rate of moderate, severe, or antibiotic-treated exacerbations. Additional assessments include spirometry, rescue medication use, the COPD assessment test, daily symptoms using the EXACT-Respiratory symptoms (E-RS) questionnaire, all-cause and COPD-related hospitalizations, and safety and pharmacokinetic measures. RESULTS: Across 17 countries, 2,354 participants were randomized from September 2011 to October 2014. Enrollment goal was met in October 2014, and study completion occurred in June 2016. CONCLUSION: This study will further characterize the effects of roflumilast added to ICS/LABA on exacerbation rates, lung function, and health of severe-very severe COPD participants at risk of further exacerbations. The results will determine the clinical benefits of roflumilast combined with standard-of-care inhaled COPD treatment.
[Mh] Termos MeSH primário: Corticosteroides/administração & dosagem
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem
Aminopiridinas/administração & dosagem
Benzamidas/administração & dosagem
Bronquite Crônica/tratamento farmacológico
Broncodilatadores/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Combinação Fluticasona-Salmeterol/administração & dosagem
Pulmão/efeitos dos fármacos
Inibidores da Fosfodiesterase 4/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Corticosteroides/efeitos adversos
Agonistas de Receptores Adrenérgicos beta 2/efeitos adversos
Idoso
Aminopiridinas/efeitos adversos
Aminopiridinas/farmacocinética
Benzamidas/efeitos adversos
Benzamidas/farmacocinética
Bronquite Crônica/diagnóstico
Bronquite Crônica/fisiopatologia
Broncodilatadores/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Ciclopropanos/administração & dosagem
Ciclopropanos/efeitos adversos
Ciclopropanos/farmacocinética
Progressão da Doença
Método Duplo-Cego
Feminino
Combinação Fluticasona-Salmeterol/efeitos adversos
Volume Expiratório Forçado
Seres Humanos
Pulmão/fisiopatologia
Masculino
Meia-Idade
Inibidores da Fosfodiesterase 4/efeitos adversos
Inibidores da Fosfodiesterase 4/farmacocinética
Doença Pulmonar Obstrutiva Crônica/diagnóstico
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Projetos de Pesquisa
Índice de Gravidade de Doença
Espirometria
Inquéritos e Questionários
Fatores de Tempo
Resultado do Tratamento
Capacidade Vital
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE IV; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adrenal Cortex Hormones); 0 (Adrenergic beta-2 Receptor Agonists); 0 (Aminopyridines); 0 (Benzamides); 0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Cyclopropanes); 0 (Fluticasone-Salmeterol Drug Combination); 0 (Phosphodiesterase 4 Inhibitors); 0P6C6ZOP5U (Roflumilast)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160831
[St] Status:MEDLINE
[do] DOI:10.2147/COPD.S109661


  8 / 113 MEDLINE  
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[PMID]:27552906
[Au] Autor:Farkas Á; Jókay Á; Balásházy I; Füri P; Müller V; Tomisa G; Horváth A
[Ad] Endereço:Centre for Energy Research, Hungarian Academy of Sciences, Konkoly-Thege Miklós út 29-33, 1121 Budapest, Hungary. Electronic address: farkas.arpad@energia.mta.hu.
[Ti] Título:Numerical simulation of emitted particle characteristics and airway deposition distribution of Symbicort(®) Turbuhaler(®) dry powder fixed combination aerosol drug.
[So] Source:Eur J Pharm Sci;93:371-9, 2016 Oct 10.
[Is] ISSN:1879-0720
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:One of the most widespread dry powder fixed combinations used in asthma and chronic obstructive pulmonary disease (COPD) management is Symbicort(®) Turbuhaler(®). The aim of this study was to simulate the deposition distribution of both components of this drug within the airways based on realistic airflow measurements. Breathing parameters of 25 healthy adults (11 females and 14 males) were acquired while inhaling through Turbuhaler(®). Individual specific emitted doses and particle size distributions of Symbicort(®) Turbuhaler(®) were determined. A self-developed particle deposition model was adapted and validated to simulate the deposition of budesonide (inhaled corticosteroid; ICS) and formoterol (long acting ß2 agonist; LABA) in the upper airways and lungs of the healthy volunteers. Based on current simulations the emitted doses varied between 50.4% and 92.5% of the metered dose for the ICS, and between 38% and 96.1% in case of LABA component depending on the individual inhalation flow rate. This variability induced a notable inter-individual spread of the deposited lung doses (mean: 33.6%, range: 20.4%-48.8% for budesonide and mean: 29.8%, range: 16.4%-42.9% for formoterol). Significant inter-gender differences were also observed. Average lung dose of budesonide was 29.2% of the metered dose for females and 37% for males, while formoterol deposited with 26.4% efficiency for females and 32.5% for males. Present results also highlighted the importance of breath-holding after inhalation of the drug. About a half of the total lung deposition occurred during breath-hold at 9.6s average breath-hold time. Calculated depositions confirmed appropriate lung deposition of Symbicort(®) Turbuhaler(®) for both genders, however more effort for optimal inhalation technique is advised for persons with low vital capacity. This study demonstrated the possibility of personalized prediction of airway deposition of aerosol drugs by numerical simulations. The methodology developed in this study will be applicable also to other marketed drugs in the future.
[Mh] Termos MeSH primário: Antiasmáticos/farmacocinética
Combinação Budesonida e Fumarato de Formoterol/farmacocinética
Modelos Biológicos
Sistema Respiratório/metabolismo
[Mh] Termos MeSH secundário: Administração por Inalação
Adulto
Antiasmáticos/química
Combinação Budesonida e Fumarato de Formoterol/química
Simulação por Computador
Inaladores de Pó Seco
Feminino
Seres Humanos
Masculino
Tamanho da Partícula
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Asthmatic Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170417
[Lr] Data última revisão:
170417
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160825
[St] Status:MEDLINE


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[PMID]:27521684
[Au] Autor:Vilà N; Chen JC
[Ad] Endereço:McGill University, Montreal, Que.; Montreal Retina Institute, Montreal, Que.
[Ti] Título:Peripapillary retinoschisis and serous retinal elevation secondary to steroid-induced glaucoma.
[So] Source:Can J Ophthalmol;51(4):e136-e138, 2016 Aug.
[Is] ISSN:1715-3360
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Glaucoma/induzido quimicamente
Glucocorticoides/efeitos adversos
Pressão Intraocular/efeitos dos fármacos
Doenças do Nervo Óptico/diagnóstico
Descolamento Retiniano/diagnóstico
Retinosquise/diagnóstico
Descolamento do Vítreo/diagnóstico
[Mh] Termos MeSH secundário: Antiasmáticos/efeitos adversos
Anti-Hipertensivos/uso terapêutico
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Angiofluoresceinografia
Glaucoma/tratamento farmacológico
Seres Humanos
Masculino
Meia-Idade
Tomografia de Coerência Óptica
Acuidade Visual
[Pt] Tipo de publicação:CASE REPORTS; LETTER
[Nm] Nome de substância:
0 (Anti-Asthmatic Agents); 0 (Antihypertensive Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination); 0 (Glucocorticoids)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170817
[Lr] Data última revisão:
170817
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160814
[St] Status:MEDLINE


  10 / 113 MEDLINE  
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[PMID]:27344046
[Au] Autor:Cazzola M; Ora J; Di Paolo A; Puxeddu E; Calzetta L; Rogliani P
[Ad] Endereço:University of Rome Tor Vergata, Department of Systems Medicine, Chair of Respiratory Medicine, Rome, Italy. Electronic address: mario.cazzola@uniroma2.it.
[Ti] Título:Onset of action of budesonide/formoterol Spiromax(®) compared with budesonide/formoterol Turbuhaler(®) in patients with COPD.
[So] Source:Pulm Pharmacol Ther;39:48-53, 2016 Aug.
[Is] ISSN:1522-9629
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Budesonide/formoterol (BF) is available in two delivery systems, the dry powder inhaler (DPI) Turbuhaler and a pressurized metered dose inhaler (pMDI) for use in patients with asthma or chronic obstructive pulmonary disease (COPD). Spiromax DPI was recently developed as an alternative to Turbuhaler DPI. In the present study, we examined whether there is a difference in the onset of bronchodilatation between BF 320/9 µg delivered by Spiromax and BF 320/9 µg delivered by Turbuhaler in 16 outpatients with stable moderate-to-severe COPD. Our results confirm the rapid onset of action of formoterol when combined with budesonide in patients with COPD and indicate that the onset of bronchodilation induced by BF Spiromax is faster than that elicited by BF Turbuhaler. Furthermore, they show that BF fixed-dose combination does not induce a decrease in SpO2 or an increase in heart rate in patients with COPD, irrespective of the DPI used to deliver this combination. Given the evidence that both inhalers have an equal safety profile, BF Spiromax offers to prescribers and COPD patients an effective alternative to BF Turbuhaler depending also on their preference, availability and cost.
[Mh] Termos MeSH primário: Broncodilatadores/administração & dosagem
Combinação Budesonida e Fumarato de Formoterol/administração & dosagem
Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração por Inalação
Idoso
Broncodilatadores/efeitos adversos
Broncodilatadores/uso terapêutico
Combinação Budesonida e Fumarato de Formoterol/efeitos adversos
Combinação Budesonida e Fumarato de Formoterol/uso terapêutico
Estudos Cross-Over
Método Duplo-Cego
Sistemas de Liberação de Medicamentos
Inaladores de Pó Seco
Feminino
Seres Humanos
Masculino
Inaladores Dosimetrados
Doença Pulmonar Obstrutiva Crônica/fisiopatologia
Índice de Gravidade de Doença
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Bronchodilator Agents); 0 (Budesonide, Formoterol Fumarate Drug Combination)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171030
[Lr] Data última revisão:
171030
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160626
[St] Status:MEDLINE



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