Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma.

UNLABELLED: This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 µg b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmacêutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 µg b.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12-65 years of age (N = 196) with uncontrolled asthma were randomized into an actively-controlled, open-labeled, parallel-group, multicentre, phase III study. The primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF). The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV(1)) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events. In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV(1) and asthma control when compared to a combination of budesonide plus formoterol. ( CLINICAL TRIAL NUMBER: ISRCTN60408425).

Nasal eosinophilia: an indicator of eosinophilic inflammation in asthma.

BACKGROUND: It is noteworthy that there is a clear clinical, epidemiological and pathophysiological association between upper and lower airway inflammation in rhinitis and asthma. OBJECTIVE: The aim of this study was to compare the eosinophil counts in induced sputum and nasal lavage fluids in asthma, checking their association and the accuracy of nasal eosinophilia as a predictor of sputum eosinophilia by a cross-sectional study. METHODS: The clinical evaluation, asthma control questionnaire (ACQ), pre- and post-bronchodilator spirometry, nasal and sputum sample was performed. The nasal eosinophilia was analysed by a receiver operating curve and logistic regression model. RESULTS: In 140 adults, the post-bronchodilator forced expiratory volume in 1 s (FEV(1)) did not differ between patients with or without sputum eosinophilia (0.18). After adjusted for upper airway symptoms, age, ACQ score and post-bronchodilator FEV(1), sputum eosinophilia was associated with 52 times increase in odds of nasal eosinophilia, whereas each 1% increase in bronchodilator response was associated with 7% increase in odds of nasal eosinophilia. CONCLUSION: This study brings further evidence that upper airway diseases are an important component of the asthma syndrome. Furthermore, monitoring of nasal eosinophilia by quantitative cytology may be useful as a surrogate of sputum cytology in as a component of composite measurement for determining airway inflammation.

Direct costs of asthma in Brazil: a comparison between controlled and uncontrolled asthmatic patients.

Asthma is a common chronic illness that imposes a heavy burden on all aspects of the patient's life, including personal and health care cost expenditures. To analyze the direct cost associated to uncontrolled asthma patients, a cross-sectional study was conducted to determine costs related to patients with uncontrolled and controlled asthma. Uncontrolled patient was defined by daytime symptoms more than twice a week or nocturnal symptoms during two consecutive nights or any limitations of activities, or need for relief rescue medication more than twice a week, and an ACQ score less than 2 points. A questionnaire about direct cost stratification in health services, including emergency room visits, hospitalization, ambulatory visits, and asthma medications prescribed, was applied. Ninety asthma patients were enrolled (45 uncontrolled/45 controlled). Uncontrolled asthmatics accounted for higher health care expenditures than controlled patients, US$125.45 and US$15.58, respectively [emergency room visits (US$39.15 vs US$2.70) and hospitalization (US$86.30 vs US$12.88)], per patient over 6 months. The costs with medications in the last month for patients with mild, moderate and severe asthma were US$1.60, 9.60, and 25.00 in the uncontrolled patients, respectively, and US$6.50, 19.00 and 49.00 in the controlled patients. In view of the small proportion of uncontrolled subjects receiving regular maintenance medication (22.2%) and their lack of resources, providing free medication for uncontrolled patients might be a cost-effective strategy for the public health system.

Direct costs of asthma in Brazil: a comparison between controlled and uncontrolled asthmatic patients

Asthma is a common chronic illness that imposes a heavy burden on all aspects of the patient's life, including personal and health care cost expenditures. To analyze the direct cost associated to uncontrolled asthma patients, a cross-sectional study was conducted to determine costs related to patients with uncontrolled and controlled asthma. Uncontrolled patient was defined by daytime symptoms more than twice a week or nocturnal symptoms during two consecutive nights or any limitations of activities, or need for relief rescue medication more than twice a week, and an ACQ score less than 2 points. A questionnaire about direct cost stratification in health services, including emergency room visits, hospitalization, ambulatory visits, and asthma medications prescribed, was applied. Ninety asthma patients were enrolled (45 uncontrolled/45 controlled). Uncontrolled asthmatics accounted for higher health care expenditures than controlled patients, US$125.45 and US$15.58, respectively [emergency room visits (US$39.15 vs US$2.70) and hospitalization (US$86.30 vs US$12.88)], per patient over 6 months. The costs with medications in the last month for patients with mild, moderate and severe asthma were US$1.60, 9.60, and 25.00 in the uncontrolled patients, respectively, and US$6.50, 19.00 and 49.00 in the controlled patients. In view of the small proportion of uncontrolled subjects receiving regular maintenance medication (22.2 percent) and their lack of resources, providing free medication for uncontrolled patients might be a cost-effective strategy for the public health system.

Morbidade respiratória nos pacientes com e sem síndrome pulmonar obstrutiva submetidos a cirurgia abdominal alta / Respiratory morbidity in patients with and without pulmonary obstructive syndrome after upper abdominal surgery

OBJETIVO: Estudar a morbidade respiratória nos pacientes com síndrome pulmonar obstrutiva submetidos a cirurgia abdominal alta. CASUÍSTICA E MÉTODO: Durante o pré-operatório, 196 pacientes candidatos à cirurgia abdominal alta eletiva responderam a um questionário padronizado e logo em seguida realizaram espirometria. Houve acompanhamento no pós-operatório até a alta hospitalar ou óbito. Os pacientes foram divididos em quatro grupos: 27 pacientes com DPOC (diagnóstico de bronquite crônica ou enfisema e VEF1/CVF < 70 por cento), 44 pacientes com diagnóstico de asma (obstrução das vias aéreas desencadeada por estímulos provocatívos) com ou sem alteração da espirometria. Outros 23 pacientes apresentavam o complexo bronquite crônica-enfisema, (quadro clínico sugestivo de bronquite ou enfisema porém com VEF1/CVF maior que 70 por cento). O grupo de 102 pacientes apresentou normalidade do ponto de vista clínico e espirométrico. Considerou-se como CPP: atelectasia com repercussão clínica e ou gasométrica, broncoespasmo que necessitou de tratamento, insuficiência respiratória aguda, ventilação mecânica e/ou entubação orotraqueal prolongada, infecção traqueobronquica e pneumonia. RESULTADOS: A incidência de complicações foi maior no grupo de pacientes com limitação do fluxo aéreo (32 por cento) em relação aos normais(6 por cento). Ao estudarmos os quatro grupos separadamente, foi observado que os pacientes com DPOC, apesar de apresentaram maior morbidade no pós-operatório, não diferiram dos demais pneumopatas. Complicaram, respectivamente, (DPOC 37 por cento, BE 34 por cento, asma 29 por cento, normal 6 por cento). Os obstrutivos triplicaram seu tempo de permanência no ventilador (média 3,1 e 1,1; respectivamente, com p<0,05). No entanto, não houve diferença em relação ao tempo de permanência na UTI e no tempo total de dias no pós-operatório. CONCLUSÃO: Os pacientes com limitação do fluxo aéreo apresentaram maior morbidade no pós-operatório de cirurgia abdominal alta. A magnitude deste fator de risco se reflete num risco relativo quase que cinco vezes maior em relação aos pneumopatas com os pacientes normais.