Evaluation of 3-5 months' add-on therapy with montelukast in patients with non-controlled asthma in Austria: the STAR open-label, real-world, observational study.

Objective: To assess the current state of asthma management in Austria and evaluate improvement of symptoms and quality of life (QoL) in asthma patients by adding the controller substance montelukast to existing therapy. Research design and methods: Office-based pneumologists across Austria were invited to participate in an open-label, multicenter observational study. Male and female patients aged from 12-50 years with mild or moderate persistent asthma according to GINA guidelines and FEV1 > 70% predicted were included if they were on concurrent asthma treatment, but still had persistent symptoms and reduced quality of life. Asthma control was assessed at time of patient anamnesis and subsequent follow-up visits. In addition, a physical examination was performed, lung function (FEV1) was measured and two types of validated QoL questionnaires were used: the Juniper Asthma Control Questionnaire was evaluated and documented by the physicians at each study visit and the Asthma Quality of Life Questionnaire was completed by the patients following each visit. Results: A total of 851 patients (343 males, 508 females) were included and 328 patients were eligible for evaluation 3-5 months after completing at least two study visits. QoL rating by patients was available for 263 at baseline and for 216 patients after 3-5 months. The physicians' rating of asthma-related QoL showed improvements between 6.66 and 11.80% in the categories: nocturnal awakening, morning asthma symptoms, reduction of daily activities, wheezing and dyspnoea, but no reduction in the use of short acting beta(2)-agonists (SABA). The QoL judged by the patients by means of the QoL-Q showed statistically significant improvements in 13 of 15 parameters of QoL. The categories: response to cigarette smoke and response to air pollution showed positive trends (not significant) while the improvement of shortness of breath, response to dust, frustration, cough, anxiety, chest pressure, sleep quality, worries about asthma, wheezing, symptoms at heavy and moderate exercise and impairment of daily activities and activities at work reached statistical significance. Conclusion: This open-label, multicenter observational study shows significant improvement in six QoL parameters evaluated by the physicians and in 13 out of 15 QoL categories judged by the patients 3-5 months after adding montelukast to the ongoing asthma treatment in patients with mild or moderate persistent asthma. Limitations to these conclusions are the lack of a placebo control group (as this was an open-label study) and the continuing basal asthma therapy, which might contribute to improvement of asthma control.