Measuring asthma control in group studies: do we need airway calibre and rescue β2-agonist use?

AbstractCollection of airway calibre and β2-agonist data in large clinical trials and epidemiological surveys is sometimes difficult and may be an inefficient use of resources. The aim of this study was to determine whether the omission of the forced expiratory volume in 1 sec (FEV1) and β2-agonist questions from the seven-item Asthma Control Questionnaire (ACQ) alters its measurement properties and validity.In an observational study, 50 adults with symptomatic asthma attended the clinic at 0, 1, 5 and 9 weeks to complete the ACQ and other measures of asthma status.All patients completed the study and provided complete data sets. Omission of the FEV1andβ2 -agonist questions from the ACQ made minimal difference to the reliability, responsiveness, and both cross-sectional and longitudinal validity of the instrument. Omission of the FEV1question significantly lowered the summary score (P<0·0001) but omission of the β2-agonist question did not alter it (P>0·05).In group studies, both the FEV1and β2-agonist questions may be omitted from the ACQ without changing the validity or the measurement properties of the instrument. Lowering of the summary score by the omission of the FEV1question means that data from this abbreviated form cannot be combined with or compared to data collected using the full questionnaire

Efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma: a double-blind, randomized, placebo-controlled study

Amburana cearensis is a medicinal plant known as "cumaru". It is used in Northeast Brazil in the treatment of respiratory diseases. This was a randomized, double-blind, placebo-controlled study, with the aim of evaluating the efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma. The study consisted of 3 phases, pre-treatment, treatment and post-treatment. The primary efficacy outcome was comparison of the changes reported by patients of the cumaru and placebo groups after treatment, using the "Asthma Quality of Life Questionnaire" (AQLQ). The secondary outcome was the effect of cumaru syrup on lung function based on spirometry. The results showed that in the cumaru group, the proportion of patients who had global improvement in asthma symptoms was significantly greater (61.90%, P=0.0009) than in the placebo group (9.52%). Only the spirometric parameters Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) showed significant intergroup differences in post-treatment (P0.05). Adverse events were reported by 3 patients (14.29%) in the cumaru group and 3 patients (14.29%) in the placebo group. All adverse events were considered non-serious and mild.Amburana cearensis é uma planta medicinal conhecida como "cumaru". No Nordeste do Brasil é usada no tratamento de doenças respiratórias. Este é um estudo randomizado, duplo-cego e controlado por placebo, com o objetivo de avaliar a eficácia e segurança do xarope de cumaru como terapia complementar da asma persistente leve. O estudo consistiu de três fases, pré-tratamento, tratamento e pós-tratamento. A variável primária para determinação da eficácia foi a comparação das mudanças referidas pelos pacientes dos grupos cumaru e placebo após o tratamento, usando o "Questionário sobre Qualidade de Vida na Asma" (QQVA). A variável secundária foi o efeito do xarope de cumaru na função pulmonar baseado na espirometria. Os resultados mostraram que no grupo cumaru, a proporção de pacientes com melhora global dos sintomas da asma foi significativamente maior (61,90%, P=0.0009) que no grupo placebo (9,52%). Somente os parâmetros espirométricos, capacidade vital forçada (CVF) e volume expiratório forçado no primeiro segundo (VEF1), mostraram diferença intergrupo significtivas no pós-tratamento (P0.05). Eventos adversos foram reportados por 3 pacientes (14,29%) no grupo cumaru e 3 (14,29%) no grupo placebo. Todos os eventos adversos foram não sérios e leves