Chronic obstructive pulmonary disease (COPD) is a public health problem. Tobacco smoking is the major cause, but not the only one. Air pollution, exposure to chemical compounds, environmental smoke exposure, and environmental tobacco smoke are among other contributing causes; viral and bacterial infection are risk factors too. Gender and weight loss are associated to the severity of the disease. Co-morbidity is frequent. Objective: To characterize a population of COPD outpatients followed at a tertiary medical service. Methods: Questionnaires were applied to patients with COPD. The data included gender, age, weight, body mass index (BMI), oxygen delivery users, and FEV1, exposure to tobacco smoke, exposure to wood smoke, tuberculosis antecedent and co-morbid diseases. Results: Of the 70 patients enrolled in the study, 70% (49) were male with an average age of 64 ± 10 years, an average weight of 63 ± 16 kg and an average BMI of 22 ± 5 kg/m2. 45,7% were oxygen dependent and the FEV1 average was 35 ± 14%. Nine (12.8%) patients never smoked, while 78.8% had quit tobacco smoking, (38 ± 11 pack/years was the average). Nine (12.8%) smoked straw cigarettes. Eighteen (25.7%) had environmental exposure to wood smoke. Eleven (15.7%) patients had tuberculosis, 5.7% complained of asthma symptoms, 2.8% had bronchiectasis, 11.4% diabetes mellitus, 51.4% hypertension, and 20% Cor pulmonale. Conclusion: Other possible COPD etiologies must be investigated. Determinants for the pulmonary injury could be environmental smoke exposure associated to former infections. Men with low BMI are typically representative of this severe patient population. Hypertension and Cor Pulmonale are frequent co-morbidity factors.

Objective: Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR), fluticasone alone (FLU), and the single-capsule combination of fluticasone/formoterol (FLU/FOR) on lung function in patients with mild-to-moderate persistent asthma. Methods: This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L) at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use. Results: We randomized 243 patients to three groups: FLU/FOR (n = 79), BUD/FOR (n = 83), and FLU (n = 81). In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49), whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52). Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002). The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations. Conclusions: The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma. (ClinicalTrials.gov Identifier:NCT01202084 [http://www.clinicaltrials.gov/])

Keywords: Asthma; Steroids; Bronchodilator agents; Administration, inhalation.

Objective: To profile the characteristics of adult patients with bronchiectasis, drawing comparisons between cystic fibrosis (CF) patients and those with bronchiectasis from other causes in order to determine whether it is rational to extrapolate the bronchiectasis treatment given to CF patients to those with bronchiectasis from other causes. Methods: A retrospective analysis of the medical charts of 87 patients diagnosed with bronchiectasis and under follow-up treatment at our outpatient clinic. Patients who had tuberculosis (current or previous) were excluded. We evaluated the clinical, functional, and treatment data of the patients. Results: Of the 87 patients with bronchiectasis, 38 (43.7%) had been diagnosed with CF, through determination of sweat sodium and chloride concentrations or through genetic analysis, whereas the disease was due to another etiology in 49 (56.3%), of whom 34 (39.0%) had been diagnosed with idiopathic bronchiectasis. The mean age at diagnosis was lower in the patients with CF than in those without (14.2 vs. 24.2 years; p < 0.05). The prevalence of symptoms (cough, expectoration, hemoptysis, and wheezing) was similar between the groups. Colonization by Pseudomonas aeruginosa or Staphylococcus aureus was more common in the CF patients (82.4 vs. 29.7% and 64.7 vs. 5.4%, respectively). Conclusions: The causes and clinical manifestations of bronchiectasis are heterogeneous, and it is important to identify the differences. It is crucial that these differences be recognized so that new strategies for the management of patients with bronchiectasis can be developed.

Keywords: Cystic fibrosis; Bronchiectasis/diagnosis; Bronchiectasis/therapy; Respiratory function tests.

Smoking causes an intense inflammatory reaction in the airways and is associated with worse clinical outcomes in patients with asthma. The objective of this study was to determine the prevalence of active and passive smoking in a population of patients with asthma. The sample of asthma patients (n = 100) consisted of 47 nonsmokers, 33 former smokers, 17 passive smokers and 3 active smokers. Most had moderate or severe asthma. Mean exhaled CO was 9.34 ppb in smokers, 4.19 ppb in passive smokers, 3.98 ppb in nonsmokers and 3.98 ppb in former smokers. We conclude that the prevalence of exposure to tobacco smoke is high among asthma patients.

Keywords: Smoking; Asthma; Prevalence.

Objective: To evaluate treatment compliance and use of inhaled medications of patients with asthma receiving complementary pharmaceutical care. Methods: A controlled prospective parallel study involving a study group and a control group. We selected 60 patients with persistent asthma and using metered-dose inhalers (MDIs), dry powder inhalers (DPIs) or both. The patients were evaluated three times over 60 days. Instructions were provided to the patients in the study group at all visits but only at the first visit to those in the control group. The patients using < 80% or > 120% of the total number of prescribed doses were classified as noncompliant. The inhalation technique was quantified by a scoring system. A satisfactory technique was defined as a score higher than 7 (maximum, 9) for MDIs and higher than 4 (maximum, 5) for DPIs. Results: The final study sample comprised 28 study group patients and 27 control group patients, of whom 18 (64.3%) and 20 (74.7%), respectively, were considered treatment compliant. From the first to the third visits, there were increases, in the study and control groups, in the median MDI-use score (from 3 [range, 0-5] to 8 [range, 8-9]; p < 0.001; and from 5 [range, 2-6] to 7 [range, 6-8]), as well as in the median DPI-use score (from 3 [range, 2-4] to 5 [range, 4-5] and from 3 [range, 2-4] to 4 [range, 3-5]). Conclusions: The counseling provided by the pharmacist to the patient was important to assist in the implementation of the appropriate inhalation technique, especially for MDI use.

Keywords: Asthma; Pharmaceutical services; Administration, inhalation;Metered dose inhalers; Medication adherence.

Objective: To evaluate the understanding of asthma and the clinical improvement in patients with moderate or severe persistent asthma prior to and after their participation in an educational program presented during the routine outpatient visits. Methods: This was a prospective pilot study involving 164 patients over a two-year period. The educational program, presented to small groups on outpatient visit days, consisted of lectures divided into three parts: pathophysiology; environmental control; and treatment, including training in the inhalation technique. The program was evaluated using standardized questionnaires on clinical improvement and understanding of the disease. Results: By the end of the first year, 120 patients had completed three visits, and 51 of those patients were revaluated at the end of the second year. The mean age of the patients was 44 years, 70% were female, and 43% had up to eight years of schooling. The educational intervention significantly increased the understanding of the disease (p < 0.001), and allowed greater clinical improvement (p < 0.05) with a decrease in the use of oral corticosteroids, fewer visits to the emergency room and fewer days missed from work or school. Conclusions: The educational program offered during the routine outpatient visits of adult patients with asthma at our clinic resulted in a progressive long-term increase in knowledge, as well as in clinical improvement.

Keywords: Asthma; Adult; Patient education as topic.

Objective: To evaluate the presence and severity of symptoms of anxiety and depression in individuals with asthma or chronic obstructive pulmonary disease. Methods: In order to evaluate symptoms of anxiety and depression, specific instruments of quantification (the State-Trait Anxiety Inventory and the Beck Depression Inventory, respectively) were administered to patients at an outpatient clinic for the treatment of asthma and chronic obstructive pulmonary disease. The population comprised 189 randomly and prospectively selected patients that were divided into three study groups (each with a different therapeutic objective): 40 patients with controlled asthma, 100 patients with uncontrolled asthma, and 49 patients with chronic obstructive pulmonary disease. Included among the variables studied, as part of the methodology, were symptoms of anxiety and depression. The data obtained were compared taking into consideration demographic and functional aspects, as well as the severity of the symptoms of anxiety and depression. Results: Among the asthma patients, the prevalence of moderate or severe anxiety was significantly higher than that observed among those with chronic obstructive pulmonary disease (p <  0.001). The uncontrolled asthma group presented significantly higher rates of depressive symptoms than did the controlled asthma group (p < 0.05). Conclusion: The frequency of symptoms of anxiety and depression is greater among asthma patients than among patients with chronic obstructive pulmonary disease, which can make clinical control difficult.

Keywords: Anxiety; Depression; Asthma; Pulmonary disease; Chronic obstructive

Objective: To identify symptoms of dysphagia in individuals with COPD, based on their responses on a self-perception questionnaire. Methods: The study comprised 35 individuals with COPD and 35 healthy individuals, matched for age and gender. The study group was assessed regarding COPD severity; sensation of dyspnea; body mass index (BMI); and symptoms of dysphagia. The control group was assessed regarding BMI and symptoms of dysphagia. Results: The most common symptoms of dysphagia in the study group were pharyngeal symptoms/airway protection (p < 0.001); esophageal symptoms/history of pneumonia (p < 0.001); and nutritional symptoms (p < 0.001). Positive correlations were found between the following pairs of variables: FEV1 and BMI (r = 0.567; p < 0.001); pharyngeal symptoms/airway protection and dyspnea (r = 0.408; p = 0.015); and esophageal symptoms/history of pneumonia and pharyngeal symptoms/airway protection (r = 0.531; p = 0.001). There was a negative correlation between nutritional symptoms and BMI (r = −0.046; p < 0.008). Conclusions: Our results show that the individuals with COPD presented with symptoms of dysphagia that were associated with the pharyngeal and esophageal phases of swallowing, as well as with the mechanism of airway protection, a history of pneumonia, and nutritional symptoms.

Keywords: Deglutition disorders; Pulmonary disease, chronic obstructive; Pathological conditions, signs and symptoms.

Objective: To evaluate the short-term impact of tiotropium in patients with severe or very severe COPD who complain of dyspnea despite being currently treated with other bronchodilators. Methods: A prospective study including patients with severe or very severe COPD and complaining of dyspnea at rest or on minimal exertion. Every 15 days, the bronchodilator treatment regimen was altered, from salmeterol to tiotropium to salmeterol+tiotropium. At the end of each regimen, pulmonary function tests and the six-minute walk test (6MWT) were performed. The degree of dyspnea and the ability to perform activities of daily living were also assessed. To evaluate patient ability to perform activities of daily living, we employed the London Chest Activity of Daily Living (LCADL), validated for use in Brazil. Results: We evaluated 52 patients, 30 of whom completed the study. The use of tiotropium in isolation resulted in significant improvement in dyspnea at baseline (mean Medical Research Council scale score reduced from 3.0 to 2.5) and at the end of 6MWT (mean Borg scale score reduced from 6.1 to 4.5), and the differences were significant (p < 0.05 for both). The use of the salmeterol+tiotropium combination resulted in a significant (81 mL) increase in FEV1 and a 5.7 point improvement in the LCADL score. Conclusions: The introduction of tiotropium into the treatment of patients with severe or very severe COPD and using long-acting β2 agonists improves pulmonary function and provides symptomatic relief, as perceived by patients in the short term. These results, obtained under real life treatment conditions, support the use of the salmeterol+tiotropium combination in specific treatment protocols for these patients.

Keywords: Pulmonary disease, chronic obstructive; Bronchodilator agents; Dyspnea; Activities of daily living.

Objective: To evaluate the ability of COPD patients to perform activities of daily living (ADL); to identify barriers that prevent these individuals from performing ADL; and to correlate those barriers with dyspnea severity, six-minute walk test (6MWT), and an ADL limitation score. Methods: In COPD patients and healthy, age-matched controls, the number of steps, the distance walked, and walking time were recorded with a triaxial accelerometer, for seven consecutive days. A questionnaire regarding perceived barriers and the London Chest Activity of Daily Living (LCADL) scale were used in order to identify the factors that prevent the performance of ADL. The severity of dyspnea was assessed with two scales, whereas submaximal exercise capacity was determined on the basis of the 6MWT. Results: We evaluated 40 COPD patients and 40 controls. In comparison with the control values, the mean walk time was significantly shorter for COPD patients (68.5  25.8 min/day vs. 105.2  49.4 min/day; p < 0.001), as was the distance walked (3.9  1.9 km/day vs. 6.4  3.2 km/day; p < 0.001). The COPD patients also walked fewer steps/day. The most common self-reported barriers to performing ADL were lack of infrastructure, social influences, and lack of willpower. The 6MWT distance correlated with the results obtained with the accelerometer but not with the LCADL scale results. Conclusions: Patients with COPD are less active than are healthy adults of a comparable age. Physical inactivity and the barriers to performing ADL have immediate implications for clinical practice, calling for early intervention measures.

Keywords: Pulmonary disease, chronic obstructive; Activities of daily living; Exercise tolerance.

Introduction: Smoking is the major preventable risk of morbidity and mortality. However, its prevalence is high in developed countries and increasing in developing countries, even though its effects are now better known. The purpose of this study was to compare the exhaled carbon monoxide concentration (exCO) between smokers and nonsmokers, evaluate the factors that influence this parameter among smokers and the potential influence of passive smoking by measuring exCO in workers and patients of Instituto do Coração HC-FMUSP. Materials and methods: This cross study included 256 volunteers who responded to a questionnaire and were submitted to exCO measuring with the MicroCo meter device. Results: There were 106 males and 150 females. Mean age was 43.4 years (Vmin-max: 15-83). There were 107 smokers, 118 nonsmokers and 31 passive smokers. Mean exCO was 14.01 ppm (Vmin-max: 1-44) among smokers, 2.03 ppm (Vmin-max: 0-5) among passive smokers and 2.50 ppm (Vmin-max: 0-9) among nonsmokers. Significant statistical difference was observed between smokers and the other groups (p < 0.001), but not between nonsmokers and passive smokers. A positive correlation was found between the number of cigarettes smoked per day and exCO values while there was a negative correlation between the exCO values and the timing of the last cigarette. For a reference limit value of 6 ppm, sensitivity was 70% and specificity was 96%. Conclusion: exCO metering is easy to perform, low-cost, noninvasive and allows the obtention of immediate results and the reference limit value of 6 ppm has good specificity to evaluate the smoking habit.

Keywords: Smoking. Carbon monoxide. Tobacco smoke pollution. Brazil.

Objective: To validate, for use in asthma prevalence studies, the asthma module of the standardized written questionnaire developed for use in the International Study of Asthma and Allergies in Childhood, establishing the score and cut-off point that would identify asthmatic adults. Methods: We interviewed 78 adult outpatients (40 adult asthmatics and 38 age-matched and gender-matched controls) using the asthma module of the International Study of Asthma and Allergies in Childhood questionnaire, which is composed of questions related to eight dichotomous features of asthma. We determined the score and cut-off point required to accurately identify asthmatic adults, calculating sensitivity, specificity and Youden index. The method was validated against the clinical and functional diagnosis of asthma. The reproducibility of individual questions was evaluated by conducting second interviews with half of the patients some weeks later. Results: The score ranged from 0 to 14 points. A score = 5 allowed patients with asthma to be distinguished from those without (sensitivity = 93%; specificity = 100%; Youden index = 0.93). Most questions presented satisfactory reproducibility in the second interviews conducted after 48.2 ± 11.1 days (kappa and weighted kappa ranging from 0.43 to 1.00 for individual questions). Conclusion: For studies of adult asthma prevalence, the determination/validation of a cut-off point allows an alternative interpretation of the information gathered through the application of the asthma module of the International Study of Asthma and Allergies in Childhood, taking into account the totality of the data rather than responses to individual questions.

Keywords: Asthma/diagnosis; Asthma/epidemiology; International cooperation; Questionnaires

Objective: To evaluate the use of inhaler devices by patients with severe asthma treated via the Programa para o Controle da Asma e Rinite Alérgica na Bahia (ProAR, Bahia State Asthma and Allergic Rhinitis Control Program), recording the frequency of their errors in performing key steps and the relationship between such errors and the lack of asthma control. Methods: A cross-sectional study involving 467 patients enrolled in the ProAR in the city of Salvador, Brazil. The devices evaluated were metered dose inhalers (MDIs), with or without a spacer, and dry powder inhalers (DPIs; Pulvinal® or Aerolizer®). For the assessment of the inhalation technique, a checklist was used; the patients were asked to demonstrate the technique so that an interviewer could observe all of the steps performed. For the assessment of asthma control, we used the 6-item asthma control questionnaire. Results: Most of the patients showed appropriate inhalation techniques when using the devices. When using an MDI, few patients made mistakes in the key step of "coordinating activation and inhalation" (5.2% and 9.1% with and without the use of a spacer, respectively). During Pulvinal® use, 39% of the patients did not inhale quickly and deeply, compared with only 5.8% during Aerolizer® use. Of the patients that made use of Aerolizer® alone, 71.3% appropriately performed all of the essential steps, and their asthma was controlled. Conclusions: Most of the patients in this sample, all of whom had been submitted to periodic checks of their inhalation technique (as part of the program), used the devices appropriately. Proper inhalation technique is associated with asthma symptom control.

Keywords: Asthma; Administration, inhalation; Metered dose inhalers; Dry powdered inhalers.

Objective: To report the results of a workshop regarding asthma management programs and centers (AMPCs) in Brazil, so that they can be used as a tool for the improvement and advancement of current and future AMPCs. Methods: The workshop consisted of five presentations and the corresponding group discussions. The working groups discussed the following themes: implementation of asthma management strategies; human resources needed for AMPCs; financial resources needed for AMPCs; and operational maintenance of AMPCs. Results: The workshop involved 39 participants, from all regions of the country, representing associations of asthma patients (n = 3), universities (n = 7), and AMPCs (n = 29). We found a direct relationship between a lack of planning and the failure of AMPCs. Based on the experiences reported during the workshop, the common assumptions about AMPCs in Brazil were the importance of raising awareness of managers; greater community participation; interdependence between primary care and specialized care; awareness of regionalization; and use of medications available in the public health system. Conclusions: Brazil already has a core of experience in the area of asthma management programs. The implementation of strategies for the management of chronic respiratory disease and their incorporation into health care system protocols would seem to be a natural progression. However, there is minimal experience in this area. Joint efforts by individuals with expertise in AMPCs could promote the implementation of asthma management strategies, thus speeding the creation of treatment networks, which might have a multiplier effect, precluding the need for isolated centers to start from zero.

Keywords: Asthma; Academic medical centers; Area health education centers; Health planning organiza-tions; Regional medical programs; Managed care programs.

Objective: Smoking prevalence is frequently estimated on the basis of self-reported smoking status. That can lead to an underestimation of smoking rates. The aim of this study was to evaluate the difference between self-reported smoking status and that determined through the use of objective measures of smoking at a pulmonary outpatient clinic. Methods: This was a cross-sectional study involving 144 individuals: 51 asthma patients, 53 COPD patients, 20 current smokers, and 20 never-smokers. Smoking status was determined on the basis of self-reports obtained in interviews, as well as through tests of exhaled carbon monoxide (eCO) and urinary cotinine. Results: All of the asthma patients and COPD patients declared they were not current smokers. In the COPD and asthma patients, the median urinary cotinine concentration was 167 ng/mL (range, 2-5,348 ng/mL) and 47 ng/mL (range, 5-2,735 ng/mL), respectively (p < 0.0001), whereas the median eCO level was 8 ppm (range, 0-31 ppm) and 5 ppm (range, 2-45 ppm), respectively (p < 0.05). In 40 (38%) of the patients with asthma or COPD (n = 104), there was disagreement between the self-reported smoking status and that determined on the basis of the urinary cotinine concentration, a concentration > 200 ng/mL being considered indicative of current smoking. In 48 (46%) of those 104 patients, the self-reported non-smoking status was refuted by an eCO level > 6 ppm, which is also considered indicative of current smoking. In 30 (29%) of the patients with asthma or COPD, the urinary cotinine concentration and the eCO level both belied the patient claims of not being current smokers. Conclusions: Our findings suggest that high proportions of smoking pulmonary patients with lung disease falsely declare themselves to be nonsmokers. The accurate classification of smoking status is pivotal to the treatment of lung diseases. Objective measures of smoking could be helpful in improving clinical management and counseling.

Keywords: Asthma; Pulmonary disease, chronic obstructive; Cotinine; Carbon monoxide; Smoking.

Objective: Mometasone furoate (MF) is a new potent synthetic inhaled corticosteroid. Internationally, MF is administered via a dry-powder inhaler that contains multiple doses. As a preparation that would be more cost-effective, single-dose MF capsules were developed in Brazil. The objective of the present study was to evaluate the efficacy and safety of the two inhalers for MF administration in patients with asthma. Methods: A randomized, multicenter, open-label, parallel-group clinical trial involving 74 adult patients with moderate persistent asthma who were randomized into two groups to receive approximately 400 µg of MF once a day for 60 days, either via the multiple-dose inhaler or via the newly developed single-dose inhaler. Results: No significant differences were observed between the two groups regarding the primary endpoints (FEV1 and rescue medication use) or the secondary endpoints (morning PEF, tolerability, and safety, the last as assessed on the basis of hypothalamic-pituitary-adrenal axis function). Conclusions: The use of the single-dose inhaler developed in Brazil for MF administration is as effective and safe as is that of a standard inhaler in the treatment of patients with asthma. Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers.

Keywords: Anti-asthmatic agents; Pregnadienediols; Metered dose inhalers. (ClinicalTrials.gov identifier: NCT00975741 [http://www.clinicaltrials.gov/])