Brazilian Journal of Pulmonology

ISSN (on-line): 1806-3756 | ISSN (printed): 1806-3713


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Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial

Avaliação da eficácia e segurança da associação de budesonida e formoterol em dose fixa e cápsula única no tratamento de asma não controlada: ensaio clínico randomizado, duplo-cego, multicêntrico e controlado

Roberto Stirbulov, Carlos Cezar Fritscher, Emilio Pizzichini, Márcia Margaret Menezes Pizzichini

J Bras Pneumol.2012;38(4):431-437

Abstract PDF PT PDF EN Portuguese Text

Objective: To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination, in comparison with budesonide alone, in patients with uncontrolled asthma. Methods: This was a randomized, double-blind, multicenter, phase III, parallel clinical trial, comparing the short-term efficacy and safety of the combination of budesonide (400 μg) and formoterol (12 μg), with those of budesonide alone (400 μg), both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma. The age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups. The treatment consisted of the administration of the medications twice a day for 12 weeks. The primary outcome measures were FEV1, FVC, and morning PEF. We performed an intention-to-treat analysis of the data. Results: In comparison with the budesonide-only group patients, those treated with the budesonide-formoterol combination showed a significant improvement in FEV1 (0.12 L vs. 0.02 L; p  =   0.0129) and morning PEF (30.2 L/min vs. 6.3 L/min; p  = 0.0004). These effects were accompanied by good tolerability and safety, as demonstrated by the low frequency of adverse events, only minor adverse events having occurred. Conclusions: The single-capsule combination of budesonide-formoterol appears to be efficacious and safe. Our results indicate that this formulation is a valid therapeutic option for obtaining and maintaining asthma control. ( Identifier: NCT01676987 [])


Keywords: Asthma; Budesonide; Adrenergic beta-2 receptor agonists.


Celebrating World Asthma Day in Brazil: is the glass half full or half empty?

Celebrando o Dia Mundial da Asma no Brasil: o copo está meio cheio ou meio vazio?

Marcia Margaret Menezes Pizzichini1,a, Álvaro Augusto Cruz2,3,b

J Bras Pneumol.2019;45(3):e20190130-e20190130

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Reliability of a rapid hematology stain for sputum cytology

Confiabilidade da coloração hematológica rápida para citologia de escarro

Jéssica Gonçalves, Emilio Pizzichini, Marcia Margaret Menezes Pizzichini, Leila John Marques Steidle, Cristiane Cinara Rocha, Samira Cardoso Ferreira, Célia Tânia Zimmermann

J Bras Pneumol.2014;40(3):250-258

Abstract PDF PT PDF EN Portuguese Text

Objective: To determine the reliability of a rapid hematology stain for the cytological analysis of induced sputum samples. Methods: This was a cross-sectional study comparing the standard technique (May-Grünwald-Giemsa stain) with a rapid hematology stain (Diff-Quik). Of the 50 subjects included in the study, 21 had asthma, 19 had COPD, and 10 were healthy (controls). From the induced sputum samples collected, we prepared four slides: two were stained with May-Grünwald-Giemsa, and two were stained with Diff-Quik. The slides were read independently by two trained researchers blinded to the identification of the slides. The reliability for cell counting using the two techniques was evaluated by determining the intraclass correlation coefficients (ICCs) for intraobserver and interobserver agreement. Agreement in the identification of neutrophilic and eosinophilic sputum between the observers and between the stains was evaluated with kappa statistics. Results: In our comparison of the two staining techniques, the ICCs indicated almost perfect interobserver agreement for neutrophil, eosinophil, and macrophage counts (ICC: 0.98-1.00), as well as substantial agreement for lymphocyte counts (ICC: 0.76-0.83). Intraobserver agreement was almost perfect for neutrophil, eosinophil, and macrophage counts (ICC: 0.96-0.99), whereas it was moderate to substantial for lymphocyte counts (ICC = 0.65 and 0.75 for the two observers, respectively). Interobserver agreement for the identification of eosinophilic and neutrophilic sputum using the two techniques ranged from substantial to almost perfect (kappa range: 0.91-1.00). Conclusions: The use of Diff-Quik can be considered a reliable alternative for the processing of sputum samples.


Keywords: Sputum\analysis; Sputum\cytology; Azure stains.


Defining asthma for epidemiologic studies: can this objective be attained?

Definir asma para estudos epidemiológicos: essa meta pode ser alcançada?

Márcia Margaret Menezes Pizzichini

J Bras Pneumol.2005;31(6):vi-viii

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Determination of the inflammatory component of airway diseases by induced sputum cell counts: use in clinical practice

Determinação do componente inflamatório das doenças das vias aéreas através do escarro induzido: utilização na prática clínica

Pablo Moritz, Leila John Marques Steidle, Manuela Brisot Felisbino, Túlia Kleveston, Marcia Margaret Menezes Pizzichini, Emilio Pizzichini

J Bras Pneumol.2008;34(11):913-921

Abstract PDF PT PDF EN Portuguese Text

Objective: To evaluate the usefulness of determining the inflammatory component of airway diseases (inflammometry) by induced sputum cell counts, as well as its influence on treatment decisions in a tertiary facility for the treatment of respiratory diseases. Methods: We analyzed 151 sputum samples from 132 consecutive patients referred for clinical sputum induction by five pulmonologists between July of 2006 and February of 2007. A structured questionnaire related to the reasons for requesting the test and to the therapeutic decision making based on test results was completed by each attending physician upon receiving the test results. Induced sputum was obtained and processed according to a technique previously described. Results: The principal motives for ordering the test were inhaled corticosteroid dose titration in patients with moderate-to-severe asthma (in 54.3%), investigation of chronic cough (in 30.5%), and monitoring airway inflammation in patients with bronchiectasis (in 7.3%) or chronic obstructive pulmonary disease (in 6%). Of the 82 patients with asthma, 47 (57%) presented eosinophilic bronchitis (>3% eosinophils). Nonasthmatic eosinophilic bronchitis was diagnosed in 9 (19%) of the 46 patients with chronic cough. Neutrophilic bronchitis (>65% neutrophils) was found in 13 patients, of which 5 had asthma, 2 had chronic cough, and 6 had chronic obstructive pulmonary disease/bronchiectasis. Based on the induced sputum results, the corticosteroid dose was modified in 48 asthma patients (64.7%). Conclusions: The systematic application of inflammometry using induced sputum cell counts can be beneficial for patients with airway diseases, particularly those with asthma or chronic cough.


Keywords: Sputum; Asthma; Bronchitis.


Effects of prednisone on eosinophilic bronchitis in asthma: a systematic review and meta-analysis

Efeitos da prednisona na bronquite eosinofílica na asma: uma revisão sistemática e meta-análise

Thiago Mamôru Sakae, Rosemeri Maurici, Daisson José Trevisol, Marcia Margaret Menezes Pizzichini, Emílio Pizzichini

J Bras Pneumol.2014;40(5):552-563

Abstract PDF PT PDF EN Portuguese Text

Objective: To evaluate the effect size of oral corticosteroid treatment on eosinophilic bronchitis in asthma, through systematic review and meta-analysis. Methods: We systematically reviewed articles in the Medline, Cochrane Controlled Trials Register, EMBASE, and LILACS databases. We selected studies meeting the following criteria: comparing at least two groups or time points (prednisone vs. control, prednisone vs. another drug, or pre- vs. post-treatment with prednisone); and evaluating parameters before and after prednisone use, including values for sputum eosinophils, sputum eosinophil cationic protein (ECP), and sputum IL-5-with or without values for post-bronchodilator FEV1-with corresponding 95% CIs or with sufficient data for calculation. The independent variables were the use, dose, and duration of prednisone treatment. The outcomes evaluated were sputum eosinophils, IL-5, and ECP, as well as post-bronchodilator FEV1. Results: The pooled analysis of the pre- vs. post-treatment data revealed a significant mean reduction in sputum eosinophils (8.18%; 95% CI: 7.69-8.67; p < 0.001), sputum IL-5 (83.64 pg/mL; 95% CI: 52.45-114.83; p < 0.001), and sputum ECP (267.60 µg/L; 95% CI: 244.57-290.63; p < 0.0001), as well as a significant mean increase in post-bronchodilator FEV1 (8.09%; 95% CI: 5.35-10.83; p < 0.001). Conclusions:In patients with moderate-to-severe eosinophilic bronchitis, treatment with prednisone caused a significant reduction in sputum eosinophil counts, as well as in the sputum levels of IL-5 and ECP. This reduction in the inflammatory response was accompanied by a significant increase in post-bronchodilator FEV1.


Keywords: Meta-analysis; Bronchitis; Asthma; Pulmonary eosinophilia; Evidence-based medicine; Prednisone.


Exacerbations of COPD and symptoms of gastroesophageal reflux: a systematic review and meta-analysis

Exacerbações de DPOC e sintomas de refluxo gastroesofágico: revisão sistemática e meta-análise

Thiago Mamôru Sakae, Márcia Margaret Menezes Pizzichini, Paulo José Zimermann Teixeira, Rosemeri Maurici da Silva, Daisson José Trevisol, Emilio Pizzichini

J Bras Pneumol.2013;39(3):259-271

Abstract PDF PT PDF EN Portuguese Text

Objective: To examine the relationship between gastroesophageal reflux (GER) and COPD exacerbations. Methods: We conducted a systematic search of various electronic databases for articles published up through December of 2012. Studies considered eligible for inclusion were those dealing with COPD, COPD exacerbations, and GER; comparing at least two groups (COPD vs. controls or GER vs. controls); and describing relative risks (RRs) and prevalence ratios-or ORs and their respective 95% CIs (or presenting enough data to allow further calculations) for the association between GER and COPD-as well as exacerbation rates. Using a standardized form, we extracted data related to the study design; criteria for GER diagnosis; age, gender, and number of participants; randomization method; severity scores; methods of evaluating GER symptoms; criteria for defining exacerbations; exacerbation rates (hospitalizations, ER visits, unscheduled clinic visits, prednisone use, and antibiotic use); GER symptoms in COPD group vs. controls; mean number of COPD exacerbations (with symptoms vs. without symptoms); annual frequency of exacerbations; GER treatment; and severity of airflow obstruction. Results: Overall, GER was clearly identified as a risk factor for COPD exacerbations (RR = 7.57; 95% CI: 3.84-14.94), with an increased mean number of exacerbations per year (mean difference: 0.79; 95% CI: 0.22-1.36). The prevalence of GER was significantly higher in patients with COPD than in those without (RR = 13.06; 95% CI: 3.64-46.87; p < 0.001). Conclusions: GER is a risk factor for COPD exacerbations. The role of GER in COPD management should be studied in greater detail.


Keywords: Pulmonary disease, chronic obstructive; Gastroesophageal reflux; Meta-analysis; Risk factors; Evidence-based medicine.


Airway inflammation in steroid-naïve asthmatics: characteristics of induced sputum

Inflamação das vias aéreas em asmáticos virgens de tratamento com esteróides: características do escarro induzido

Simone Van de Sande Lee, Marcia Margaret Menezes Pizzichini, Leila John Marques, Samira Cardoso Ferreira, Emilio Pizzichini

J Bras Pneumol.2003;29(4):188-195

Abstract PDF PT

Background: Airway inflammation, acknowledged as an important feature of asthma, can be assessed by the examination of induced sputum. Objective: To determine the pattern of inflammatory cells in induced sputum from stable steroid-naïve asthmatics, in Florianópolis, Santa Catarina. Method: The induced sputum from 34 asthmatics using exclusively inhaled bronchodilators on demand was examined. The patients' clinical characteristics were obtained at visit 1, and sputum was induced at visit 2. Differential cell count was performed on Giemsa-stained cytospins. Sputum was considered to be eosinophilic if there were ³ 3% eosinophils, and neutrophilic if there were ³ 65% neutrophils. Results: Results are expressed by median and interquartile range. The total cell count was 3.4 (3.7) x 106 cells/ml, and cell viability was 80.0 (16.4) %. The proportion of neutrophils was 14.4 (22.1) %, of eosinophils 6.4 (17.2) %, of macrophages 60.3 (37.5) %, and of lymphocytes 1.1 (1.2) %. Eosinophilic sputum was observed in 24 subjects (70.6%); none of them had neutrophilic sputum. There were no significant differences between the eosinophilic and non-eosinophilic groups concerning the measured clinical outcomes, total cell count and proportions of cells in the sputum, except for the proportion of eosinophils (14.4 [19.3] vs 0.4 [1.1], p < 0.001). Conclusions: In our environment, steroid-naïve asthmatics present a higher proportion of sputum eosinophils, as compared to the established reference values. The clinical and physiological parameters analyzed were unable to predict the presence of eosinophilic inflammation of the airways.


Keywords: Asthma. Inflammation. Sputum. Eosinophils. Neutrophils.


Is the COPD Assessment Test sensitive for differentiating COPD patients from active smokers and nonsmokers without lung function impairment? A population-based study

O COPD Assessment Test é sensível para diferenciar pacientes com DPOC de indivíduos tabagistas e não tabagistas sem a doença? Um estudo de base populacional

Manuela Karloh1,2,a, Simone Aparecida Vieira Rocha1,b, Marcia Margaret Menezes Pizzichini1,3,c, Francine Cavalli1,d, Darlan Laurício Matte1,2,4,e, Emilio Pizzichini1,3,f; The Respira Floripa Group

J Bras Pneumol.2018;44(3):213-219

Abstract PDF PT PDF EN Portuguese Text

Objective: To assess COPD Assessment Test (CAT) scores in adults with and without COPD, as well as to compare the CAT scores for nonsmokers, former smokers, and smokers without COPD with those for patients with COPD. Methods: This was a cross-sectional population-based study (the Respira Floripa study). The study included adults ≥ 40 years of age residing in the city of Florianópolis, Brazil. A total of 846 households were surveyed. In addition to completing the Respira Floripa questionnaire and the CAT, participants underwent pulmonary function testing. Results: We analyzed data on 1,057 participants (88.1% of the predicted sample size). A functional diagnosis of COPD was made in 92 participants (8.7%). Of those, 72% were unaware that they had COPD. The mean CAT score was higher in the group of COPD patients than in that of individuals without COPD (10.6 [95% CI: 8.8-12.4] vs. 6.6 [95% CI: 6.1-7.0]; p < 0.01). Individual item scores were significantly higher in the patients with COPD than in the individuals without COPD (p < 0.001), the exception being the scores for the items related to sleep (p = 0.13) and energy (p = 0.08). The mean CAT score was higher in the group of COPD patients than in nonsmokers (5.8 [95% CI: 5.3-6.4]) and former smokers (6.4 [95% CI: 5.6-7.2]; p < 0.05). However, there were no significant differences in the mean CAT score between the group of COPD patients and smokers without COPD (9.5 [95% CI: 8.2-10.8]; p > 0.05), the exception being the mean scores for confidence leaving home (p = 0.02). Conclusions: CAT scores were higher in the group of patients with COPD than in nonsmokers and former smokers without COPD. However, there were no significant differences in CAT scores between COPD patients and smokers without COPD. Smokers with an FEV1/FVC ratio > 0.70 have impaired health status and respiratory symptoms similar to those observed in COPD patients.


Keywords: Respiratory function tests; Pulmonary disease, chronic obstructive; Smoking.


Prevalence of smoking and reasons for continuing to smoke: a population-based study

Prevalência de tabagismo e motivos para continuar a fumar: estudo de base populacional

Simone Aparecida Vieira Rocha1,a, Andréa Thives de Carvalho Hoepers1,b, Tânia Silvia Fröde2,c, Leila John Marques Steidle3,d, Emilio Pizzichini3,e, Márcia Margaret Menezes Pizzichini3,f

J Bras Pneumol.2019;45(4):e20170080-e20170080

Abstract PDF PT PDF EN Portuguese Text

Objective: To investigate the prevalence of smoking and the reasons for continuing to smoke among adults in Brazil. Methods: This was a cross-sectional, population-based study including 1,054 individuals ≥ 40 years of age, residents of the city of Florianopolis, Brazil, of whom 183 were smokers. All of the smokers completed the University of São Paulo Reasons for Smoking Scale (USP-RSS). Depressive symptoms were evaluated with the Hospital Anxiety and Depression Scale, and spirometry was performed to screen for COPD. Results: Of the 183 smokers, 105 (57.4%) were female, 138 (75.4%) were White, and 125 (63.8%) were in a low economic class. The mean level of education among the smokers was 9.6 ± 6.1 years. The mean smoking history was 29 ± 15 pack-years, 59% of the men having a ≥ 30 pack-year smoking history. Approximately 20% of the smokers had COPD, and 29% had depressive symptoms, which were more common in the women. The USP-RSS scores were highest for the pleasure of smoking (PS), tension reduction (TR), and physical dependence (PD) domains (3.9 ± 1.1, 3.6 ± 1.2, and 3.5 ± 1.3, respectively). Scores for the PS, TR, and weight control (WC) domains were significantly higher in women. Smokers with a > 20 pack-year smoking history scored significantly higher on the PD, PS, automatism, and close association (CA) domains. Smoking history was associated with the PD, PS, TR, and CA domains. Depressive symptoms were associated with the PD, social smoking, and CA domains (p = 0.001; p = 0.01; p = 0.09, respectively). Female gender and a low level of education were associated with the PS domain (p = 0.04) and TR domain (p < 0.001). Conclusions: The prevalence of smoking in our sample was relatively high (17.4%). The USP-RSS domains PS, TR, and WC explain why individuals continue smoking, as do depressive symptoms.


Keywords: Smoking/epidemiology; Tobacco use disorder/psychology; Smoking cessation/methods; Prevalence.


Leicester Cough Questionnaire: translation to Portuguese and cross-cultural adaptation for use in Brazil

Questionário de Leicester sobre tosse crônica: tradução e adaptação cultural para a língua portuguesa falada no Brasil

Manuela Brisot Felisbino, Leila John Marques Steidle, Michelle Gonçalves-Tavares, Marcia Margaret Menezes Pizzichini, Emilio Pizzichini

J Bras Pneumol.2014;40(3):213-221

Abstract PDF PT PDF EN Portuguese Text Appendix

Objective: To translate the Leicester Cough Questionnaire (LCQ) to Portuguese and adapt it for use in Brazil. Methods: Cross-cultural adaptation of a quality of life questionnaire requires a translated version that is conceptually equivalent to the original version and culturally acceptable in the target country. The protocol used consisted of the translation of the LCQ to Portuguese by three Brazilian translators who were fluent in English and its back-translation to English by another translator who was a native speaker of English and fluent in Portuguese. The back-translated version was evaluated by one of the authors of the original questionnaire in order to verify its equivalence. Later in the process, a provisional Portuguese-language version was thoroughly reviewed by an expert committee. In 10 patients with chronic cough, cognitive debriefing was carried out in order to test the understandability, clarity, and acceptability of the translated questionnaire in the target population. On that basis, the final Portuguese-language version of the LCQ was produced and approved by the committee. Results: Few items were questioned by the source author and revised by the committee of experts. During the cognitive debriefing phase, the Portuguese-language version of the LCQ proved to be well accepted and understood by all of the respondents, which demonstrates the robustness of the process of translation and cross-cultural adaptation. Conclusions: The final version of the LCQ adapted for use in Brazil was found to be easy to understand and easily applied.


Keywords: Quality of life; Translations; Questionnaires; Cough.


Prescribing trends in and perceptions of the treatment of asthma: a survey among pulmonologists in Brazil

Tendências prescritivas e percepções no tratamento da asma: um inquérito entre pneumologistas brasileiros

José Eduardo Delfini Cançado1,a, Rodrigo Abensur Athanazio2,b, Luis Fernando Rensi Cunha3,c, Marcia Margaret Menezes Pizzichini4,d

J Bras Pneumol.2019;45(5):e20190083-e20190083

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Translation and cultural adaptation of a specific instrument for measuring asthma control and asthma status: the Asthma Control and Communication Instrument

Tradução e adaptação cultural de um instrumento específico para medir o controle e estado da asma: Asthma Control and Communication Instrument

Michelle Gonçalves de Souza Tavares, Carolina Finardi Brümmer, Gabriela Valente Nicolau, José Tavares de Melo Jr, Nazaré Otilia Nazário, Leila John Marques Steidle, Cecília Maria Patino, Marcia Margaret Menezes Pizzichini, Emílio Pizzichini

J Bras Pneumol.2017;43(4):264-269

Abstract PDF PT PDF EN Portuguese Text Appendix

Objective: To translate the Asthma Control and Communication Instrument (ACCI) to Portuguese and adapt it for use in Brazil. Methods: The ACCI was translated to Portuguese and adapted for use in Brazil in accordance with internationally accepted guidelines. The protocol included the following steps: permission and rights of use granted by the original author; translation of the ACCI from English to Portuguese; reconciliation; back-translation; review and harmonization of the back-translation; approval from the original author; review of the Portuguese version of the ACCI by an expert panel; cognitive debriefing (the clarity, understandability, and acceptability of the translated version being tested in a sample of the target population); and reconciliation and preparation of the final version. Results: During the cognitive debriefing process, 41 asthma patients meeting the inclusion criteria completed the ACCI and evaluated the clarity of the questions/statements. The clarity index for all ACCI items was > 0.9, meaning that all items were considered to be clear. Conclusions: The ACCI was successfully translated to Portuguese and culturally adapted for use in Brazil, the translated version maintaining the psychometric properties of the original version. The ACCI can be used in clinical practice because it is easy to understand and easily applied.


The Asthma Control Scoring System: Translation and cross-cultural adaptation for use in Brazil

Tradução e adaptação cultural do Asthma Control Scoring System (Sistema de Escore para Controle Abrangente da Asma) para uso no Brasil

Michelle Gonçalves de Souza Tavares, Márcia Margaret Menezes Pizzichini, Leila John Marques Steidle, Nazaré Otília Nazário, Cristiane Cinara Rocha, Maíra Chiaradia Perraro, Emílio Pizzichini

J Bras Pneumol.2010;36(6):683-692

Abstract PDF PT PDF EN Portuguese Text Appendix

Objective: The translation and cross-cultural adaptation of a specific scoring instrument for the comprehensive control of asthma, the Asthma Control Scoring System (ACSS), for use in Brazil. Methods: The protocol included ten steps: acquisition of written permission from the author of the ACSS; translation of the instrument to Brazilian Portuguese, carried out by three separate translators; analysis and comparison of the three versions by a review committee; literal back-translation to English; review and harmonization of the back-translation; acquisition of the approval of the original author; review of the translation by specialists; cognitive debriefing: test of clarity to, understanding by, and acceptance of the target population (evaluation of the translation by 10 health care workers); second cognitive debriefing: review of the revised version by a second group of health care workers; and reconciliation and preparation of the final version by the review committee. Results: The Brazilian Portuguese-language version of the ACSS showed clarity, understandability, and acceptability. The instrument was considered to be comprehensive because it includes the clinical manifestations of asthma, as well as the functional and inflammatory aspects of the disease. Conclusions: With the use of this careful methodology in the translation and cross-cultural adaptation of the ACSS, we have ensured its cultural adequacy for Brazil. The use of this instrument could facilitate future studies on asthma control.


Keywords: Asthma/classification; Asthma/prevention & control; Questionnaires.




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