Jussara Fiterman

Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial.

RATIONALE Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle. OBJECTIVES To evaluate the effectiveness and safety of BT versus a sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting beta(2)-agonists. METHODS A total of 288 adult subjects (Intent-to-Treat [ITT]) randomized to BT or sham control underwent three bronchoscopy procedures. Primary outcome was the difference in Asthma Quality of Life Questionnaire (AQLQ) scores from baseline to average of 6, 9, and 12 months (integrated AQLQ). Adverse events and health care use were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary endpoint (96.4%). MEASUREMENTS AND MAIN RESULTS The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 +/- 1.10; sham, 1.16 +/- 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Seventy-nine percent of BT and 64% of sham subjects achieved changes in AQLQ of 0.5 or greater (PPS, 99.6%). Six percent more BT subjects were hospitalized in the treatment period (up to 6 wk after BT). In the posttreatment period (6-52 wk after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits, and days missed from work/school compared with the sham group (PPS, 95.5, 99.9, and 99.3%, respectively). CONCLUSIONS BT in subjects with severe asthma improves asthma-specific quality of life with a reduction in severe exacerbations and healthcare use in the posttreatment period. Clinical trial registered with www.clinialtrials.gov (NCT00231114).

Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma

BACKGROUND Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.

Tratamento farmacológico da DPOC

Approximately seven million Brazilians over 40 years of age have COPD. In recent years, major advances have been made in the pharmacological treatment of this condition. We performed a systematic review including original articles on pharmacological treatments for COPD. We reviewed articles written in English, Spanish, or Portuguese; published between 2005 and 2009; and indexed in national and international databases. Articles with a sample size < 100 individuals were excluded. The outcome measures were symptoms, pulmonary function, quality of life, exacerbations, mortality, and adverse drug effects. Articles were classified in accordance with the Global Initiative for Chronic Obstructive Lung Disease criteria for the determination of the level of scientific evidence (grade of recommendation A, B, or C). Of the 84 articles selected, 40 (47.6%), 18 (21.4%), and 26 (31.0%) were classified as grades A, B, and C, respectively. Of the 420 analyses made in these articles, 236 were regarding the comparison between medications and placebos. Among these 236 analyses, the most commonly studied medications (in 66, 48, and 42 analyses, respectively) were long-acting anticholinergics; the combination of long-acting β(2) agonists and inhaled corticosteroids; and inhaled corticosteroids in isolation. Pulmonary function, adverse effects, and symptoms as outcomes generated 58, 54, and 35 analyses, respectively. The majority of the studies showed that the medications evaluated provided symptom relief; improved the quality of life and pulmonary function of patients; and prevented exacerbations. Few studies analyzed mortality as an outcome, and the role that pharmacological treatment plays in this outcome has yet to be fully defined. The medications studied are safe to use in the management of COPD and have few adverse effects.

Prevalência de sintomas de asma e tratamento de crianças e adolescentes de 2 a 14 anos no Campus Aproximado da PUCRS

BACKGROUND: In recent decades, the prevalence of asthma has increased. OBJECTIVES: To determine the prevalence of asthma symptoms in children and adolescents from 2 to 14 years of age living in Porto Alegre (in the state of Rio Grande do Sul, Brazil) and to determine any potential correlations with socioeconomic profile, treatment and smoking in the home. METHODS: A transversal study based on interviews of all families seeking medical attention in June of 2000. RESULTS: The prevalence of asthma symptoms was 49.5%. In 66.8% of families, total income was less than four times the minimum wage, and in more than 50% of homes, the parents had had less than five years of schooling. In 98.5%, prophylactic asthma treatment was not used. In the 174 families studied, 38.7% of mothers and 43.7% of fathers were smokers (32.7% overall). Correlations were found between the following variables: exposure to smoking in the home and number of asthma attacks in the last year (p = 0.02; RR = 2.9; CI: 1.1 - 4.5); maternal level of education and number of attacks in the last year (p = 0.03; RR = 2.03; CI: 1.01 -4.19); close living quarters and number of attacks in the last year among children exposed to second-hand smoke (p = 0.04; RR = 2.7; CI: 1.4 - 5.1); hospitalization and number of attacks in the last year (p = 0.004; RR = 1.46; CI: 1.15 -1.86); hospitalization and close living quarters (p = 0.03; RR = 1.47; CI: 1.15 - 1.86). In children below the age of five, there was correlation between maternal smoking and number of attacks in the last year (p = 0.03; RR = 1.79; CI: 1.04 -3.08). CONCLUSION: The prevalence of asthma symptoms was high. The community studied has limited socioeconomic resources, and there is therefore a lack of adequate treatment for asthma. Our results demonstrate the need for prioritized, standardized treatment programs that would give healthcare workers access to the appropriate materials and means of evaluation necessary for asthma control.

A workshop on asthma management programs and centers in Brazil: reviewing and explaining concepts

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.

Avaliação da eficácia clínica, aceitabilidade e preferência de dois sistemas inalatórios de beclometasona no tratamento da asma: Pulvinal® versus Aeroliser®

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 mg/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.

Mudança da tendência da mortalidade por asma em crianças e adolescentes no Rio Grande do Sul: 1970-1998

Introduction: During the period from 1970 to 1992, mortality from asthma in children and young adults increased in Rio Grande do Sul. The present study aimed at assessing this phenomenon in patients of the same age group, now extending the time period to 1998. Methods: The death certificates of 157 patients aged between 5 and 19 years in which asthma was reported to be the cause of death during 1970-80 were reviewed. Testing for trends was conducted using the log-linear, S-curve, and quadratic models. Results: Asthma mortality rate ranged from 0.04 to 0.399/100,000. Among the tested models, S curve trend model showed the best accuracy for the adjusted time series: r2=0.59; mean absolute percentage error (MAPE) = 23.48; mean absolute deviation (MAD) = 0.035; mean square deviation (MSD) = 0.0021. These results suggest that a plateau has probably been reached. The quadratic model also showed good accuracy values suggesting that a decrease in the coefficients probably started to occur. In this model, the estimated maximal point value was found in the 25th year (1994). Conclusions: Stabilization of asthma death rates is starting to occur in Rio Grande do Sul and it is likely that a decrease will take place.

Histiocitose de células de Langerhans: rápida resolução após cessação do tabagismo

We describe a case of pulmonary Langerhans cell histiocytosis with a close temporal relationship between smoking cessation and radiological improvement. High-resolution computed tomography revealed multiple small nodules located in the upper and middle lobes of both lungs. Microscopy of these lesions showed histiocytic infiltration that reacted strongly to staining for S100 protein. The histiocytes resembling Langerhans cells showed strong reactivity for S100 protein. Smoking cessation was recommended and the patient complied. Chest X-ray and computed tomography performed 6 and 24 months later revealed almost complete resolution of the radiographic abnormalities. Despite the possibility that this evolution was attributable to spontaneous remission, in this case, the lesions did, in fact, disappear rapidly after smoking cessation.

Asthma and lower airway diseaseBronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma

BACKGROUND Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.

Long term safety and effectiveness in patients with severe persistent asthma.

BACKGROUND Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma. OBJECTIVE We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy. METHODS BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.govNCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans. RESULTS One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV₁ values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT. CONCLUSIONS These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β₂-agonists.