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 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. (ClinicalTrials.gov Identifier: NCT01676987 [http://www.clinicaltrials.gov/])

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

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/])

Objective: To determine the frequency of near-fatal asthma in a group of severe asthma patients, as well as the clinical characteristics and prognosis of these patients within a one-year follow-up period. Methods: A prospective study involving 731 low-income patients with severe asthma treated at a referral outpatient clinic located in the city of Salvador, Brazil. The patients were submitted to spirometry at admission, received medications for asthma, and were monitored regarding the frequency of asthma exacerbations during the follow-up period. A subsample of 511 patients also completed questionnaires regarding asthma symptoms and asthma-related quality of life. Results: Of the 731 patients studied, 563 (77%) were female. The median age was 47 years, and 12% were illiterate. Most of the patients had rhinitis, and 70 patients (10%) reported near-fatal asthma prior to admission. Of these 70 patients, 41 (59%) reported having been intubated previously. The patients reporting a history of near-fatal asthma at admission were more likely to have asthma exacerbations during the follow-up period and to respond poorly to therapy than were those not reporting such a history. At the end of the follow-up period, the scores on the two questionnaires were similar between the two groups of patients. Conclusions: The frequency of near-fatal asthma was high in this group of low-income patients with severe asthma. The patients with a history of near-fatal asthma had a worse prognosis than did those without such a history, although both groups had received the same kind of treatment. Curiously, the intensity of symptoms and the quality of life at the end of the study were similar between the two groups.

Keywords: Asthma/prevention and control; Asthma/complications; Quality of life; Prognosis.

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: Clinical trials have shown that nintedanib 150 mg twice daily (bid) reduces disease progression in patients with idiopathic pulmonary fibrosis (IPF), with an adverse event profile that is manageable for most patients. Prior to the approval of nintedanib as a treatment for IPF in Brazil, an expanded access program (EAP) was initiated to provide early access to treatment and to evaluate the safety and tolerability of nintedanib in this patient population. Methods: Patients with a diagnosis of IPF within the previous five years, forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity of the lungs for carbon monoxide (DLco) 30% to 79% predicted were eligible to participate in the EAP. Patients received nintedanib 150 mg bid open-label. Safety assessments included adverse events leading to permanent discontinuation of nintedanib and serious adverse events. Results: The EAP involved 57 patients at eight centers. Most patients were male (77.2%) and white (87.7%). At baseline, mean (SD) age was 70.7 (7.5) years and FVC was 70.7 (12.5) % predicted. Mean (SD) exposure to nintedanib was 14.4 (6.2) months; maximum exposure was 22.0 months. The most frequently reported adverse events considered by the investigator to be related to nintedanib treatment were diarrhea (45 patients, 78.9%) and nausea (25 patients, 43.9%). Adverse events led to permanent discontinuation of nintedanib in 16 patients (28.1%). Sixteen patients (28.1%) had a serious adverse event. Conclusion: In the Brazilian EAP, nintedanib had an acceptable safety and tolerability profile in patients with IPF, consistent with data from clinical trials.

Keywords: Drug tolerance; Expanded access program; Interstitial lung disease; Tyrosine kinase inhibitor.

Objective: Pulmonary rehabilitation programs, including exercise training, have an established role in the treatment of chronic respiratory diseases but are not routinely used in asthma. Most studies of individuals with asthma have focused on endurance training, and there is therefore limited data available on strength training. The aim of this study was to evaluate the effects that adding strength training to a program of endurance training and education has on the quality of life of such individuals. Methods: In this single-center, parallel-group randomized controlled trial, adults with moderate-to-severe asthma admitted for in-hospital pulmonary rehabilitation between June of 2021 and October of 2022 were randomized to either a study group (SG) or a control group (CG). The SG received strength training alongside endurance training and education, whereas the CG received the same endurance training and education, along with sham mobility exercise training instead of strength training. The primary outcome was the change in the Asthma Quality of Life Questionnaire (AQLQ) score from hospital admission to discharge. Results: A total of 61 participants were randomized, with 31 being assigned to the SG and 30 being assigned to the CG. At discharge, the AQLQ score showed significant improvement in both groups (p < 0.001 for the SG and p = 0.02 for the CG), albeit without a significant difference between the groups (p > 0.99). In contrast, peripheral muscle strength improved significantly from admission to discharge only in the SG, with a significant difference between the groups in terms of quadriceps strength (p = 0.03). Conclusions: Adding strength training to endurance training and education does not seem to result in further improvement in the quality of life of individuals with moderate-to-severe asthma.

Keywords: Rehabilitation; Asthma; Exercise therapy; Resistance training; Exercise tolerance; Quality of life. (ClinicalTrials.gov identifier: NCT04935125 [http://www.clinicaltrials.gov/])

Objective: Asthma is the most common chronic pulmonary disease, characterized by bronchial inflammation. Some children with asthma have persistent pulmonary function impairment. The prevalence and etiology of this abnormality in children with asthma in developing countries remain unknown. The objective of this study was to estimate the proportion of patients with impaired pulmonary function who were unresponsive to treatment in a group of children and adolescents with asthma, and to describe the phenotypic characteristics of the sample. Methods: Using a standardized questionnaire, we selected outpatients (5-17 years of age) diagnosed with persistent asthma. These patients underwent spirometry and skin prick tests for sensitivity to common aeroallergens. Persistent pulmonary function impairment was defined as an FEV1/FVC ratio < 0.80, even after 10 days of treatment with bronchodilators and oral corticosteroids. We used the atopic index to differentiate between patients with little or no response to the skin prick test and those with a strong response (cut-off point: 4 allergens). Results: We included 96 patients with a mean age of 10.6 years. Of those, 52 (54.1%) were male, and 89 (92.7%) were atopic. Of the 96 patients, 8 (8.3%) had impaired pulmonary function even after the treatment. Among those patients, 8 (100%) were atopic, 7 (87.5%) had moderate or severe asthma, and 7 (87.5%) had a history of hospitalization for acute bronchiolitis. Conclusions: Children and adolescents with moderate or severe asthma can present with impaired pulmonary function and be unresponsive to treatment. This clinical situation has been little studied in developing countries, and its risk factors and etiology will be better understood only through birth cohort studies.

Keywords: Asthma; Respiratory function tests; Allergy and immunology.

Objective: To compare 28-day mortality rates and clinical outcomes in ICU patients with ventilator-associated pneumonia according to the diagnostic strategy used. Methods: This was a prospective randomized clinical trial. Of the 73 patients included in the study, 36 and 37 were randomized to undergo BAL or endotracheal aspiration (EA), respectively. Antibiotic therapy was based on guidelines and was adjusted according to the results of quantitative cultures. Results: The 28-day mortality rate was similar in the BAL and EA groups (25.0% and 37.8%, respectively; p = 0.353). There were no differences between the groups regarding the duration of mechanical ventilation, antibiotic therapy, secondary complications, VAP recurrence, or length of ICU and hospital stay. Initial antibiotic therapy was deemed appropriate in 28 (77.8%) and 30 (83.3%) of the patients in the BAL and EA groups, respectively (p = 0.551). The 28-day mortality rate was not associated with the appropriateness of initial therapy in the BAL and EA groups (appropriate therapy: 35.7% vs. 43.3%; p = 0.553; and inappropriate therapy: 62.5% vs. 50.0%; p = 1.000). Previous use of antibiotics did not affect the culture yield in the EA or BAL group (p = 0.130 and p = 0.484, respectively). Conclusions: In the context of this study, the management of VAP patients, based on the results of quantitative endotracheal aspirate cultures, led to similar clinical outcomes to those obtained with the results of quantitative BAL fluid cultures. (Brazilian Registry of Clinical Trials - ReBEC; identification number RBR-86DCDX [http://www.ensaiosclinicos.gov.br])

Keywords: Bronchoalveolar lavage fluid/diagnosis; Respiratory aspiration; Pneumonia, ventilator-associated.

Background: Pulmonary rehabilitation is widely recommended for the treatment of chronic obstructive pulmonary disease. Objective: To evaluate the efficacy of pulmonary rehabilitation in improving exercise capacity, respiratory muscle strength and quality of life of chronic obstructive pulmonary disease patients. Method: This was an open, non-randomized clinical trial involving 27 clinically stable ex-smokers with chronic obstructive pulmonary disease who were enrolled in a pulmonary rehabilitation program. All were evaluated before and after pulmonary rehabilitation. Results: Mean age was 65 ± 5 years, mean body mass index was 25 ± 4 kg/m2, mean forced expiratory volume in one second was 55 ± 25% of predicted, mean ratio between forced expiratory volume in one second and forced vital capacity was 50 ± 12%, and mean arterial oxygen tension was 70 ± 7 mmHg. Comparison of pre- and post-pulmonary rehabilitation values revealed improvement in the distance walked in the 6-minute walk test (513 ± 99 m vs. 570 ± 104 m), maximum upper limb load (2 ± 1 kg vs. 3 ± 1 kg) and maximal inspiratory pressure (-89 ± 23 cmH2O vs. -102 ± 23 cmH2O), as well as in the activity domain, impact domain and total score on the Saint George's Respiratory Questionnaire. Conclusion: Pulmonary rehabilitation, when performed with care and with a focus on physical training, is efficacious in increasing not only the distance walked in the 6-minute walk test but maximum upper limb load, maximal inspiratory pressure and quality of life as well.

Keywords: Key words: Pulmonary rehabilitation. Chronic obstructive pulmonary disease. Quality of life. Respiratory muscles.

Objective: To analyze adolescents clinically diagnosed with asthma, in terms of the physiological changes occurring during acute hypoxia and during a maximal stress test. Methods: This was a descriptive, cross-sectional study involving 48 adolescents (12-14 years of age) who were divided into three groups: mild intermittent asthma (MIA, n = 12); mild persistent asthma (MPA, n = 12); and control (n = 24). All subjects were induced to acute hypoxia and were submitted to maximal stress testing. Anthropometric data were collected, and functional variables were assessed before and after the maximal stress test. During acute hypoxia, the time to a decrease in SpO2 and the time to recovery of SpO2 (at rest) were determined. Results: No significant differences were found among the groups regarding the anthropometric variables or regarding the ventilatory variables during the stress test. Significant differences were found in oxygen half-saturation pressure of hemoglobin prior to the test and in PaO2 prior to the test between the MPA and control groups (p = 0.0279 and p = 0.0116, respectively), as was in the oxygen extraction tension prior to the test between the MIA and MPA groups (p = 0.0419). There were no significant differences in terms of the SpO2 times under any of the conditions studied. Oxygen consumption and respiratory efficiency were similar among the groups. The use of a bronchodilator provided no significant benefit during the hypoxia test. No correlations were found between the hypoxia test results and the physiological variables. Conclusions: Our findings suggest that adolescents with mild persistent asthma have a greater capacity to adapt to hypoxia than do those with other types of asthma.

Keywords: Asthma; Adolescent; Cell hypoxia; Exercise test.

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.

Keywords: : Asthma; Budesonide; Bronchodilator agents; Drug therapy, combination.

Acceptability, preference, tolerance and clinical efficacy of dipropionate beclomethasone delivered by two inhalation devices in chronic asthma patients: Clenil pulvinal versus Miflasona Aerolizer Background: Approximately half of all asthmatic patients adhere to their prescribed treatment regimen, which makes noncompliance with treatment one of the main problems associated with the disease. It is possible that inhalation devices combining technological advances with comfort and simplicity of use could increase treatment compliance. Objective: To compare the acceptability of and preference for two inhalation devices (Pulvinal and Aerolizer), as well as to evaluate the efficacy of and tolerance for beclomethasone dipropionate when delivered by these two systems. Method: A multicenter, randomized, crossover parallel study was carried out involving 83 patients with stable asthma. Patients received 500-1000 g/day of beclomethasone dipropionate. After a 2-week run in, the patients were randomized to begin a 4-week crossover treatment period with equivalent doses of Clenil Pulvinal (CP) or Miflasona Aerolizer (MA). Results: Both groups showed improvement in dyspnea and FEV1, and acceptability was considered good or excellent in both groups. Of the patients studied, 50.6% preferred CP, and 39% preferred MA. In their future treatment regimes, 54.5% would choose the CP and 37.7% the MA. Conclusion: Clinical efficacy and acceptability were comparable between CP and MA.

Keywords: Asthma/therapy. Beclomethasone/ administration & dosage. Randomized controlled trials. Treatment Outcome.

Objective: To estimate the rates of recurrence, cure, and treatment abandonment in patients with pulmonary tuberculosis treated with a four-drug fixed-dose combination (FDC) regimen, as well as to evaluate possible associated factors. Methods: This was a retrospective observational study involving 208 patients with a confirmed diagnosis of pulmonary tuberculosis enrolled in the Hospital Tuberculosis Control Program at the Institute for Thoracic Diseases, located in the city of Rio de Janeiro, Brazil. Between January of 2007 and October of 2010, the patients were treated with the rifampin-isoniazid-pyrazinamide (RHZ) regimen, whereas, between November of 2010 and June of 2013, the patients were treated with the rifampin-isoniazid-pyrazinamide-ethambutol FDC (RHZE/FDC) regimen. Data regarding tuberculosis recurrence and mortality in the patients studied were retrieved from the Brazilian Case Registry Database and the Brazilian Mortality Database, respectively. The follow-up period comprised two years after treatment completion. Results: The rates of cure, treatment abandonment, and death were 90.4%, 4.8%, and 4.8%, respectively. There were 7 cases of recurrence during the follow-up period. No significant differences in the recurrence rate were found between the RHZ and RHZE/FDC regimen groups (p = 0.13). We identified no factors associated with the occurrence of recurrence; nor were there any statistically significant differences between the treatment groups regarding adverse effects or rates of cure, treatment abandonment, or death. Conclusions: The adoption of the RHZE/FDC regimen produced no statistically significant differences in the rates of recurrence, cure, or treatment abandonment; nor did it have any effect on the occurrence of adverse effects, in comparison with the use of the RHZ regimen.

Keywords: Tuberculosis, pulmonary, Drug combinations; Recurrence.

Objective: Non-small cell lung carcinoma (NSCLC) is the most common type of lung cancer. Most patients are diagnosed at an advanced stage, palliative chemotherapy therefore being the only treatment option. This study was aimed at evaluating the health-related quality of life (HRQoL) of advanced-stage NSCLC patients receiving palliative chemotherapy with carboplatin and paclitaxel. Methods: This was a multiple case study of advanced-stage NSCLC outpatients receiving chemotherapy at a public hospital in Rio de Janeiro, Brazil. The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire was used in conjunction with its supplemental lung cancer-specific module in order to assess HRQoL. Results: Physical and cognitive functioning scale scores differed significantly among chemotherapy cycles, indicating improved and worsened HRQoL, respectively. The differences regarding the scores for pain, loss of appetite, chest pain, and arm/shoulder pain indicated improved HRQoL. Conclusions: Chemotherapy was found to improve certain aspects of HRQoL in patients with advanced-stage NSCLC.

Keywords: Carcinoma, non-small-cell lung; Quality of life; Palliative care; Carboplatin; Paclitaxel.

Objective: To compare the effects of voluntary breath stacking (VBS) and involuntary breath stacking (IBS) techniques on respiratory mechanics, lung function patterns, and inspiratory capacity in tracheostomized patients. Methods: This was a randomized crossover clinical trial involving 20 tracheostomized patients admitted to the ICU and submitted to the VBS and IBS techniques, in random order, with an interval of 5 h between each. Ten cycles of each technique were performed with an interval of 30 s between each cycle. In VBS, patients performed successive inspirations for up to 30 s through a one-way valve, whereas in IBS, successive slow insufflations were performed with a resuscitator bag until the pressure reached 40 cmH2O. Respiratory mechanics, inspiratory capacity, and the lung function pattern were evaluated before and after the interventions. Results: After IBS, there was an increase in static compliance (p = 0.007), which was also higher after IBS than after VBS (p = 0.03). There was no significant difference between the pre-VBS and post-VBS evaluations in terms of static compliance (p = 0.42). Inspiratory capacity was also greater after IBS than after VBS (2,420.7 ± 480.9 mL vs. 1,211.3 ± 562.8 mL; p < 0.001), as was airway pressure (38.3 ± 2.6 cmH2O vs. 25.8 ± 5.5 cmH2O; p < 0.001). There were no changes in resistance or lung function pattern after the application of either technique. Conclusions: In comparison with VBS, IBS promoted greater inspiratory capacity and higher airway pressure, resulting in an increase in static compliance.

Keywords: Mucociliary clearance; Respiratory care units; Respiratory mechanics; Physical therapy modalities.

Objective: Studies assessing the characteristics and management of patients hospitalized with asthma have been limited to a small number of facilities and have evaluated short time periods. The present study evaluated long-term changes among hospitalized asthma patients at a large number of facilities. Methods: This was a retrospective, hospital-based observational case series, designated the Study of Severe Asthma in Latin America and Spain, which was conducted in Spain and in eight Latin-American countries. We reviewed the hospital records of 3,038 patients (age range, 15-69 years) hospitalized with acute severe asthma at one of nineteen tertiary-care hospitals in 1994, 1999 and 2004. Results: Over time, the use of inhaled corticosteroids and long-acting β2 agonists increased significantly, whereas the use of theophylline as a controller medication decreased. The utilization of pulmonary function tests also increased. There was a significant reduction in the mean hospital stay (8.5 days, 7.4 days and 7.1 days in 1994, 1999 and 2004, respectively, p = 0.0001) and a significant increase in the mean of the lowest arterial pH at hospital admission. In contrast, there was a significant decrease in the proportion of cases in which PEF was determined in the emergency room (48.6% in 1994 vs. 43.5% in 2004, p = 0.0001). We found the quality of asthma management and care to be generally better in Spain than in Latin America. Conclusions: Although there have been certain improvements in the management of asthma between severe exacerbations and during hospitalization, asthma management remains suboptimal in Spain and, especially, in Latin America.

Keywords: Status asthmaticus; Asthma/therapy; Hospitalization.

Objective: To evaluate the relationship between obesity and asthma. Methods: This was a preliminary cross-sectional analysis involving 925 subjects with mild-to-moderate or severe asthma evaluated between 2013 and 2015. Obesity was defined on the basis of body mass index (BMI) and abdominal circumference. We collected clinical, laboratory, and anthropometric parameters, as well as pulmonary function test results and data regarding comorbidities. The subjects also completed asthma control and quality of life questionnaires. Results: Obese individuals had a significantly higher number of neutrophils in peripheral blood than did nonobese individuals (p = 0.01). Among the obese individuals, 163 (61%) had positive skin-prick test results, as did 69% and 71% of the individuals classified as being overweight or normal weight, respectively. Obese individuals showed lower spirometric values than did nonobese individuals, and 32% of the obese individuals had uncontrolled asthma, a significantly higher proportion than that found in the other groups (p = 0.02). Conclusions: Obese individuals with asthma seem to present with poorer asthma control and lower pulmonary function values than do nonobese individuals. The proportion of subjects with nonatopic asthma was higher in the obese group. Our results suggest that obese individuals with asthma show a distinct inflammatory pattern and are more likely to present with difficult-to-control asthma than are nonobese individuals.

Keywords: Asthma; Obesity; Overweight; Eosinophilia.

Objective: Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism, being characterized by persistent obstruction of pulmonary vessels and leading to increased pulmonary vascular resistance and right ventricular failure. Although pulmonary endarterectomy is the preferred treatment, medical therapies may offer clinical benefits in specific settings. We sought to evaluate the clinical and hemodynamic response of CTEPH patients treated with sildenafil and ambrisentan upfront combination therapy. Methods: This was a retrospective cohort study including patients with operable and inoperable CTEPH. The patients were followed from 2019 to 2022 and were treated with sildenafil and ambrisentan as first-line therapy. Results: Functional and hemodynamic data were analyzed at baseline and after a minimum of six months of therapy. Following treatment, there was a notable improvement in functional class, natriuretic peptide levels, and invasive hemodynamics. Conclusions: The combined use of sildenafil and ambrisentan appears to be associated with clinical, functional, and hemodynamic improvement in patients with CTEPH.

Keywords: Pulmonary Embolism; Drug therapy, combination; Hypertension, pulmonary.