Bronchodilator use in asthma: the art of prescribing bronchodilators correctly, taking advantage of their differences and reducing risks

Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUNIFESP, EPMSciEL

Asthma, a chronic disease whose manifestations go beyond respiratory distress, physical limitation and impaired quality of life

Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUNIFESP, EPMSciEL

Pharmaceutical equivalence of the combination formulation of budesonide and formoterol in a single capsule with a dry powder inhaler

OBJECTIVE: To evaluate the pharmaceutical equivalence of a test formulation (fixed-dose combination of budesonide and formoterol fumarate in a single capsule dispensed in an Aerocaps® inhaler) in relation to a reference formulation (budesonide and formoterol fumarate in two separate capsules dispensed in an Aerolizer® inhaler). METHODS: This was an in vitro study in which we performed the identification/quantification of the active ingredients by HPLC and determined dose uniformity and aerodynamic particle size distribution in the test and reference formulations. RESULTS: In the test formulation, the content of budesonide and formoterol was 111.0% and 103.8%, respectively, compared with 110.5% and 104.5%, respectively, in the reference formulation. In the test formulation, dose uniformity regarding budesonide and formoterol was 293.2 µg and 10.2 µg, respectively, whereas it was 353.0 µg and 11.1 µg in the reference formulation. These values are within the recommended range for this type of formulation (75-125% of the labeled dose). The fine particle fraction (< 5 µm) for budesonide and formoterol was 45% and 56%, respectively, in the test formulation and 54% and 52%, respectively, in the reference formulation. CONCLUSIONS: For both of the formulations tested, the levels of active ingredients, dose uniformity, and aerodynamic diameters were suitable for use with the respective dry powder inhalers.OBJETIVO: Avaliar a equivalência farmacêutica da formulação teste (associação fixa de budesonida e fumarato de formoterol em cápsula única dispensada com o dispositivo Aerocaps®) em relação a uma formulação referência (budesonida e fumarato de formoterol em duas cápsulas distintas dispensadas com o dispositivo Aerolizer®). MÉTODOS: Estudo in vitro no qual foram realizadas identificação/quantificação dos ingredientes ativos por HPCL e determinação da uniformidade da dose liberada e da distribuição aerodinâmica das partículas das formulações teste e referência. RESULTADOS: Na formulação teste, o teor de budesonida e de formoterol foi de 111,0% e 103,8%, respectivamente, enquanto esse foi de 110,5% e 104,5% na formulação referência. Na formulação teste, a uniformidade das doses de budesonida e de formoterol foi de 293,2 µg e 10,2 µg, respectivamente, enquanto essa foi de 353,0 µg e 11,1 µg na formulação referência. Esses resultados estão dentro da faixa recomendada para esse tipo de formulação (75-125% da dose rotulada). A fração de partículas finas (< 5 µm) para budesonida e formoterol foi de, respectivamente, 45% e 56% na formulação teste e de 54% e 52% na formulação referência. CONCLUSÕES: As formulações teste e referência apresentaram níveis de ingredientes ativos, uniformidade de doses e diâmetros aerodinâmicos apropriados ao uso com seus respectivos dispositivos inalatórios de pó.Hospital Pró-CardíacoUniversidade Federal de Minas Gerais Hospital das Clínicas Ambulatório de Cessação do Tabagismo Residência de PneumologiaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUNIFESP, EPMSciEL

Education of the asthmatic patient: the nursing approach

Background: Asthma education programs induce better asthma control and are one of main recommendations in guidelines. The programs recommendations should include a nurse in the educational team applying the structured program. The purpose of the intervention is to bring a change in the daily life of the patient and the family in order to improve disease control and quality of life. Aim: To standardize and apply a structured post-consultation model as part of multidisciplinary care in an educational program for asthmatic patients seen at the outpatient clinic of a public hospital, and to monitor the changes in asthma knowledge and quality of life. Methods: A longitudinal prospective study over six months with regular visits at four week intervals (total = 6 visits), conducted at the outpatient department of UNIFESP/EPM/HSP, and the patients were included after signing a consent form. The asthma structured educational plan was conducted by a multidisciplinary team and addressed the following issues: what is asthma, relief and prevention medicines, daily report of symptoms and dyspnea score, training of the correct use of inhaled medication, discussion and actions regarding triggering factors and how to avoid them, and tips to recognize the signals of uncontrolled asthma. A standard questionnaire about general knowledge on asthma and a quality of life questionnaire were applied at the beginning, during the course, and at the end of the program. Results: 26 asthmatics were followed over six months and showed a statistically significant improvement in their identification and management of asthma skills as well as better quality of life indices. Conclusion: The model of care and the approach and training techniques were adequate and useful in the development of a structured educational program for socially deprived patients.Introdução: Programas de educação em asma levam a melhor controle da asma e são uma das recomendações dos consensos. Os programas devem incluir uma enfermeira no grupo educacional que aplicará o programa estruturado. A proposta da intervenção é mudar a vida diária do paciente e sua família e melhorar o controle da doença e qualidade de vida. Objetivo: Padronizar e aplicar um modelo estruturado de pós-consulta, como parte de atendimento multidisciplinar dentro de um programa educativo para pacientes asmáticos em um ambulatório de um hospital público e acompanhamento das mudanças no conhecimento da asma e qualidade de vida. Método: Estudo longitudinal, prospectivo, com duração de seis meses, realizado no ambulatório de Pneumologia do Hospital São Paulo (UNIFESP/EPM), dentro de um programa de educação para pacientes asmáticos, em que foram agendadas seis consultas, com intervalo de quatro semanas, com os seguintes temas: o que é asma, medicações de alívio e prevenção, diário de sintomas e escore de dispnéia, uso correto do aerossol, discussão dos fatores desencadeantes e profilaxia, e também reconhecer os sinais de descontrole da asma. Um modelo padronizado do questionário de conhecimentos sobre asma e outro sobre qualidade de vida foram aplicados no início, durante e no final do estudo. Resultados: 26 asmáticos foram acompanhados por seis meses e mostraram melhora significante na identificação dos problemas relacionados ao manejo da asma, como também nos índices de qualidade de vida. Conclusão: O modelo de atendimento, como também as técnicas de treinamento, foram adequadas e úteis no desenvolvimento de um programa educativo estruturado para pacientes asmáticos.Universidade Federal de São Paulo (UNIFESP)Universidade Federal de São Paulo (UNIFESP) Disciplina de PneumologiaFaculdade de Medicina Unisa Disciplina de PneumologiaUNIFESP, Disciplina de PneumologiaSciEL

Reproducibility of the Brazilian Portuguese version of the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire used in conjunction with its lung cancer-specific module

OBJECTIVE: The assessment of the quality of life in patients with lung cancer has become one of the main goals in current clinical trials. To assess the quality of life of these patients, the most widely used instrument is the 30-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) in conjunction with its supplemental 13-item lung cancer-specific module (QLQ-LC13). The objective of this study was to assess the reproducibility of the Brazilian Portuguese version of these questionnaires. METHODS: A prospective study involving 30 stable outpatients with lung cancer who completed the instruments on the first day of the study and two weeks later. RESULTS: The test-retest reproducibility using the intraclass correlation coefficient for the EORTC QLQ-C30 and the QLQ-LC13 ranged from 0.64 to 1.00 and from 0.64 to 0.95, respectively. No correlations were found between the domains of the instruments and clinical parameters. CONCLUSIONS: Our findings show that these instruments were reproducible in this sample of patients with lung cancer in Brazil.OBJETIVO: A avaliação da qualidade de vida em pacientes com câncer de pulmão tem se tornado um dos principais objetivos em ensaios clínicos atuais. Para avaliar a qualidade de vida desses pacientes, o instrumento mais utilizado é o 36-item European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) em conjunto com seu módulo específico para câncer de pulmão com 13 itens (QLQ-LC13). O objetivo deste estudo foi avaliar a reprodutibilidade da versão em português do Brasil desses questionários. MÉTODOS: Estudo prospectivo com 30 pacientes ambulatoriais estáveis com câncer de pulmão, os quais completaram os instrumentos no primeiro dia do estudo e duas semanas depois. RESULTADOS: A reprodutibilidade teste-reteste através do coeficiente de correlação intraclasse para o EORTC QLQ-C30 e o QLQ-LC13 variou de 0,64 a 1,00 e de 0,64 a 0,95, respectivamente. Não houve correlações entre os domínios dos instrumentos e os parâmetros clínicos. CONCLUSÕES: Estes achados demonstram a reprodutibilidade dos instrumentos utilizados nesta amostra de pacientes com câncer de pulmão no Brasil.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Ambulatório de OncopneumologiaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de MedicinaUNIFESP, EPM, Ambulatório de OncopneumologiaUNIFESP, EPM, Depto. de MedicinaSciEL

Reliability of the Brazilian version of the Functional Assessment of Cancer Therapy‐Lung (FACT‐L) and the FACT‐Lung Symptom Index (FLSI)

OBJECTIVES: The purpose of this study was to assess the reliability of the Brazilian version of the Functional Assessment of Cancer Therapy-Lung (FACT-L) with the FACT-Lung Symptom Index (FLSI) questionnaire. INTRODUCTION: The assessment of quality of life in patients with lung cancer has become an important evaluative endpoint in current clinical trials. For lung cancer patients, one of the most common quality of life tools available is the FACT-L. Despite the amount of data available regarding this questionnaire, there are no data on its performance in Brazilian lung cancer patients. METHODS: The FACT-L with the FLSI questionnaire was prospectively administered to 30 consecutive, stable, lung cancer outpatients at baseline and at 2 weeks. RESULTS: The intraclass correlation coefficient between test and retest for the FACT-L ranged from 0.79 to 0.96 and for the FLSI was 0.87. There was no correlation between these questionnaire dimensions and clinical or functional parameters. CONCLUSIONS: The Brazilian version of the FACT-L with FLSI questionnaire is reliable and is quick and simple to apply. This instrument can now be used to properly evaluate the quality of life of Brazilian lung cancer patients

Non-small cell lung cancer in never smokers: a clinical entity to be identified

OBJECTIVES: It has been recognized that patients with non-small cell lung cancer who are lifelong never-smokers constitute a distinct clinical entity. The aim of this study was to assess clinical risk factors for survival among neversmokers with non-small cell lung cancer. METHODS: All consecutive non-small cell lung cancer patients diagnosed (n = 285) between May 2005 and May 2009 were included. The clinical characteristics of never-smokers and ever-smokers (former and current) were compared using chi-squared or Student's t tests. Survival curves were calculated using the Kaplan-Meier method, and log-rank tests were used for survival comparisons. A Cox proportional hazards regression analysis was evaluated by adjusting for age (continuous variable), gender (female vs. male), smoking status (never- vs. ever-smoker), the Karnofsky Performance Status Scale (continuous variable), histological type (adenocarcinoma vs. non-adenocarcinoma), AJCC staging (early vs. advanced staging), and treatment (chemotherapy and/or radiotherapy vs. the best treatment support). RESULTS: Of the 285 non-small cell lung cancer patients, 56 patients were never-smokers. Univariate analyses indicated that the never-smoker patients were more likely to be female (68% vs. 32%) and have adenocarcinoma (70% vs. 51%). Overall median survival was 15.7 months (95% CI: 13.2 to 18.2). The never-smoker patients had a better survival rate than their counterpart, the ever-smokers. Never-smoker status, higher Karnofsky Performance Status, early staging, and treatment were independent and favorable prognostic factors for survival after adjusting for age, gender, and adenocarcinoma in multivariate analysis. CONCLUSIONS: Epidemiological differences exist between never- and ever-smokers with lung cancer. Overall survival among never-smokers was found to be higher and independent of gender and histological type

Anxiety and depression in asthma patients: impact on asthma control

OBJECTIVE: There is evidence that asthma is associated with an increase in psychiatric symptoms and mental disorders. This association can make it difficult to achieve asthma control. The purpose of this study was to determine whether the level of asthma control is associated with anxiety and depression. METHODS: A crosssectional study involving 78 patients with confirmed moderate or severe asthma and under regular treatment at the Asthma Outpatient Clinic of the Federal University of São Paulo Hospital São Paulo, in the city of São Paulo, Brazil. The patients were divided into two groups by asthma control status, as assessed by the asthma control test, and were subsequently compared in terms of demographic, clinical, and spirometric data, as well as scores for asthma quality of life and hospital anxiety/depression. RESULTS: The sample was predominantly female. Of the 78 patients, 49 (63%) were classified as having uncontrolled asthma. The prevalence of anxiety and of anxiety+depression was significantly higher among patients with uncontrolled asthma than among those with controlled asthma (78% and 100%; p = 0.04 and p = 0.02, respectively), whereas there were no differences between the two groups in terms of the prevalence of depression, spirometry results, or quality of life score. CONCLUSIONS: In this sample, the prevalence of anxiety symptoms was higher in the patients with uncontrolled asthma than in those with controlled asthma.In the evaluation of asthma patients, the negative impact of mood states ought to be taken into consideration when asthma control strategies are being outlined.OBJETIVO: Existem evidências da associação entre asma e sintomas psiquiátricos e transtornos mentais. Essa associação pode resultar em dificuldades de se atingir o controle da asma. O objetivo deste estudo foi avaliar a associação de ansiedade e depressão com o controle da asma. MÉTODOS: Estudo transversal com 78 pacientes asmáticos com diagnóstico confirmado de asma moderada a grave e regularmente tratados no Ambulatório de Asma do Hospital São Paulo da Universidade Federal de São Paulo (UNIFESP), São Paulo (SP). Os pacientes foram divididos em dois grupos em relação ao status de controle de asma, determinado através do teste de controle da asma, e, posteriormente, comparados em termos de dados demográficos, clínicos e espirométricos, escore do questionário de qualidade de vida para asma e escore da escala hospitalar de ansiedade e depressão. RESULTADOS: A maioria era do sexo feminino. Dos 78 pacientes, 49 (63%) foram classificados como tendo asma não controlada. A prevalência de ansiedade e do binômio ansiedade/depressão foi significantemente maior entre os pacientes não controlados do que nos controlados (78% e 100%; p = 0,04 e p = 0,02, respectivamente), enquanto nem prevalência de depressão, nem os dados espirométricos ou de qualidade de vida diferiram entre os grupos. CONCLUSÕES: Nesta amostra, os pacientes com asma não controlada apresentaram uma maior prevalência de sintomas de ansiedade que aqueles com asma controlada. Na avaliação de pacientes asmáticos, deve-se considerar o impacto negativo dos distúrbios de humor nas estratégias de controle da asma.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Programa de Pós-Graduação em PneumologiaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de PneumologiaUNIFESP, EPM, Programa de Pós-Graduação em PneumologiaUNIFESP, EPM, Depto. de PneumologiaSciEL

Influence of oscillating positive expiratory pressure and the forced expiratory technique on sputum cell counts and quantity of induced sputum in patients with asthma or chronic obstructive pulmonary disease

OBJECTIVE: To evaluate whether respiratory therapy techniques influence the number of cells within and quantity of induced sputum in patients with asthma or chronic obstructive pulmonary disease (COPD). METHODS: Randomized clinical trial, in which patients with asthma or COPD under intervention (n = 16 and 10, respectively) were compared with control groups (n = 16 and 10). Patients in the asthma/intervention (A/I) and COPD/intervention (C/I) groups were submitted to oscillating positive expiratory pressure maneuvers for 5 min, followed by 10 forced expiratory technique sequences. These patients were also submitted to an induced sputum protocol with inhaled hypertonic saline (3%, 4% or 5%; A/I group) or inhaled isotonic saline (C/I group). The asthma/control (A/C) and COPD/control (C/C) groups were submitted only to the standard induced sputum protocol. RESULTS: The final mean weight of the sputum samples was significantly greater in the A/I group than in the A/C group (2,767.25 ± 998.08 mg vs. 1,689.17 ± 1,189.96 mg; p = 0.03). The mean/median total cell counts (×10(6)/mL) were higher in the A/I and C/I groups than in the A/C and C/C groups (4.06/0.95 and 0.63/0.39, p = 0.05, vs. 5.08/1.77 and 0.64/0.40, p = 0.02). There were no statistically significant differences among the groups in terms of cell viability. CONCLUSIONS: The use of respiratory therapy techniques can increase sputum sample weight in asthma patients, as well as increasing total cell counts in patients with asthma or COPD.OBJETIVO: Avaliar se técnicas fisioterápicas interferem no número de células e na quantidade do escarro obtido por coleta induzida, em pacientes com asma e doença pulmonar obstrutiva crônica (DPOC). MÉTODOS: Ensaio clínico prospectivo e randomizado, no qual os pacientes com asma ou DPOC sob intervenção (n = 16 e 10, respectivamente) foram comparados com grupos controle (n = 16 e 10). Pacientes dos grupos asma/intervenção (A/I) e DPOC/intervenção (D/I) foram submetidos a manobras de pressão expiratória positiva oscilante por 5 min, seguidas de 10 repetições da técnica de expiração forçada. Além disso, esses pacientes foram submetidos a um protocolo de indução de escarro com a inalação de solução salina hipertônica (3%, 4% e 5%), no caso dos A/I, e de solução salina isotônica, no caso dos D/I. Os grupos asma/controle(A/C) e DPOC/controle (D/C) foram somente submetidos ao protocolo padrão de indução de escarro. RESULTADOS: Houve aumento significante do peso média final de escarro no grupo A/I vs. grupo A/C (2.767,25 ± 998,08 mg e 1.689,17 ± 1.189,96 mg, respectivamente; p = 0,03). O número absoluto de células (×10(6)/mL) foi maior nos grupos A/I e D/I do que nos grupos A/C e D/C (média/mediana, 4,06/0,95 e 0,63/0,39, respectivamente; p = 0,05; e 5,08/1,77 e 0,64/0,40; p = 0,02). A viabilidade celular não apresentou diferença estatisticamente significante entre os grupos. CONCLUSÕES: O uso de técnicas respiratórias pode aumentar o peso do escarro em pacientes com asma, assim como aumentar o número absoluto de células em pacientes com asma ou DOPC.Universidade Regional IntegradaUniversidade Federal de São Paulo (UNIFESP)UNIFESPSciEL