Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA.

Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 µg once-daily add-on therapy. Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV1 was recorded at each time point. Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all P<0.001]). Changes in CAT total score from baseline to Month 6 indicated that the average clinical impact of COPD was reduced from a severe (score: 21-30) to a moderate (score: 11-20) impairment. In DACOTA, mean change in post-bronchodilator FEV1 was 202 mL (P<0.001). Diarrhea, nausea, and weight decrease were the most frequently reported adverse drug reactions. Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life.

Impact of tiotropium + olodaterol on physical functioning in COPD: results of an open-label observational study.

BACKGROUND: Maintaining and improving physical functioning is key to mitigating the cycle of deconditioning associated with chronic obstructive pulmonary disease (COPD). We evaluated the impact of free combination of the long-acting anticholinergic tiotropium plus the long-acting ß2-agonist olodaterol on physical functioning in a real-world clinical setting. METHODS: In this open-label noninterventional study, Global initiative for chronic Obstructive Lung Disease (GOLD) B-D patients with COPD aged ≥40 years were treated for 4-6 weeks with either tiotropium 5 µg + olodaterol 5 µg (both via Respimat(®) inhaler) or tiotropium 18 µg (HandiHaler(®)) + olodaterol 5 µg (Respimat(®)) once daily. Physical functioning was assessed by the self-reported 10-item Physical Functioning Questionnaire (PF-10). The primary end point was the percentage of patients achieving therapeutic success, defined as a 10-point increase in the PF-10 between baseline (visit 1) and weeks 4-6 (visit 2). Secondary end points included absolute PF-10 scores, Physicians' Global Evaluation, satisfaction with Respimat(®) and adverse events. RESULTS: A total of 1,858 patients were treated: 1,298 (69.9%) with tiotropium 5 µg + olodaterol 5 µg and 560 (30.1%) with tiotropium 18 µg + olodaterol 5 µg. At study end, 1,683 (92.6%) and 1,556 patients (85.6%) continued using tiotropium and olodaterol, respectively; 48.9% (95% confidence interval: 46.5, 51.3) achieved the primary end point. Therapeutic success rates were significantly higher for maintenance-naïve patients compared to those who had received prior therapy (59.1% vs 44.5%; P<0.0001), largely driven by maintenance-treatment-naïve GOLD B (59.8%) and C (63.0%) patients. Absolute physical functioning scores increased from an average baseline of 44.0 (standard deviation: 25.2) to 54.2 (standard deviation: 26.9) at visit 2. Patients' general condition improved from baseline to visit 2, and patients were largely satisfied with the Respimat(®) inhaler. Adverse events were reported by 7.5% of patients; the most common were respiratory in nature. CONCLUSION: Tiotropium + olodaterol improved physical functioning within 4-6 weeks in patients with moderate-to-very severe COPD. GOLD B and C patients with no prior maintenance treatment demonstrated the greatest benefit.

Design, synthesis, and miniemulsion polymerization of new phosphonate surfmers and application studies of the resulting nanoparticles as model systems for biomimetic mineralization and cellular uptake.

Heterophase polymerizations have gained increasing attention in the past decades, especially as the decoration and functionalization of the particle surface for further applications gets more and more into focus. One promising approach for the functionalization exclusively on the particle surface is the use of surfmers (surfactant and monomer). Herein, we present the synthesis of a new family of surfmers and their use for decorating nanoparticles with phosphonate groups through miniemulsion polymerization. Furthermore the synthesis of a dye-labeled functional surfmer provided an elegant manner to evaluate and get deeper insights about its copolymerization. Additionally, potential applications of the synthesized particles in biological studies as well as their use as template for biomimetic mineralization are presented.