<p>First-Line Treatment with Tiotropium/Olodaterol Improves Physical Activity in Patients with Treatment-Naïve Chronic Obstructive Pulmonary Disease</p>

Abstract

Background Comparative effects on physical activity of mono and dual bronchodilators remain unclear in patients with treatment-naïve chronic obstructive pulmonary disease (COPD). We sought to compare the changes in physical activity before and after tiotropium and tiotropium/olodaterol treatment in treatment-naïve COPD patients. Methods A prospective, multicenter, randomized, open-labeled, and parallel interventional study was conducted. Eighty Japanese patients with treatment-naïve COPD were randomized to receive either tiotropium or tiotropium/olodaterol treatment for 12 weeks. Spirometry and dyspnea index were assessed, and COPD assessment test (CAT) and the 6-minute walk distance (6MWD) were conducted before and after treatment. Evaluation of physical activity was assessed by a triaxle accelerometer over a 2-week period before and after treatment. Results There were no differences in the mean age (69.8 vs 70.4 years), body mass index (BMI) (22.5 vs 22.6 kg/m 2 ) and mean % forced expiratory volume in 1 second (%FEV1) at baseline (61.5 vs 62.6%) between the two groups. Changes in FEV1 (mean±standard error, 242.8±28.8 mL) and transient dyspnea index (TDI) (2.4±0.3 points) before and after tiotropium/olodaterol treatment were greater than with tiotropium treatment (104.1±31.9 mL, p<0.01 and 1.5±0.3, p=0.02, respectively). Changes in the duration of physical activity with 1.0–1.5 metabolic equivalents (METs) estimated in the sedentary position following tiotropium/olodaterol treatment (−38.7±14.7 min) tended to be reduced more than with tiotropium treatment (−4.6±10.6 min) (p=0.06), although those with ≥2.0 METs numerically increased with both treatments (+10.8±7.6 min for tiotropium/olodaterol vs +8.3±7.6 min for tiotropium, p=0.82). Tiotropium/olodaterol treatment reduced the duration of physical activity with 1.0–1.5 METs (regression coefficient, −43.6 [95% CI −84.1, −3.1], p=0.04) in a multiple regression model adjusted for cofounding factors such as age, FEV1, total CAT scores, 6MWD, and TDI. Conclusion This is the first study to report the impact of dual bronchodilator on physical activity in treatment-naïve COPD patients of Japanese with low BMI.

Associations of Exercise Tolerance and Clinical Parameters in Japanese Patients With Chronic Obstructive Pulmonary Disease: Impact of Skeletal Muscle

“…Indeed, a prospective, observational study of 130 COPD patients showed that ECM CSA is correlated with clinical parameters of COPD and more correlated with all-cause mortality than PM CSA 20 . In addition, a longitudinal, 10-year observational study showed that loss of ECM CSA , but not PM CSA , significantly increased the hazard ratio of mortality 21 , because physical activity is the strongest predictor of the prognosis of COPD patients 3 , and sedentary behavior, which affects the anti-gravity muscles, is particularly important in COPD 29,30 ; thus, anti-gravity muscles might contribute to exercise tolerance in patients with COPD, as seen in the present study.…”

Future concepts in bronchodilation for COPD: dual- versus monotherapy

“…Clinical trial evidence has consistently demonstrated greater efficacy in lung function, symptom and exacerbation outcomes with LAMA/LABA therapy versus monotherapy, with a similar safety profile [42,45,47,[53][54][55][56][57][58][59][60][61][62][63][64][65]. Crucially, several recent studies have suggested that these treatment differences are also apparent in maintenance-naïve and ICS-free COPD populations, who more closely resemble those at first presentation in clinical settings [45,[58][59][60][61][62][63][64][65]. There is also evidence that LAMA/LABA combination treatments prevent future disease deteriorations, measured by CID events [41,42,45,47,59].…”

“…There is little evidence of the impact of dual therapy on physical activity in maintenance-naïve patients. The SCOPE study in Japanese patients found no significant difference in 6-min walk distance, daily number of steps or changes in the duration of physical activity in patients treated with TIO/OLO versus TIO [65].…”

“…Numerous studies have investigated the efficacy of dual-versus mono-bronchodilation in patients with COPD, many of which have focussed on symptomatic patients without enrichment for patients with a history of exacerbations, and have frequently included patients already receiving maintenance treatment [42,47,[53][54][55][56][57][58]. Some post hoc and prospective analyses of dual-versus mono-bronchodilation have also been conducted in maintenance-naïve patients (table 1) [45,[58][59][60][61][62][63][64][65] and provide evidence concerning initial pharmacological treatment. Here, we summarise current evidence for dual-versus mono-bronchodilation in maintenance-treated and maintenance-naïve patients.…”

“…Lung function efficacy of dual-and mono-bronchodilation has been evaluated in maintenance-naïve patients with COPD (table 1) [45,[58][59][60][61][62][63][64][65][66]. In a 12-week prospective study in maintenance-naïve Japanese patients, mean FEV 1 improvement with TIO/olodaterol (OLO) was two-fold higher compared with TIO [65]. A pre-specified analysis of EMAX in maintenance-naïve patients reported greater improvements in lung function with UMEC/VI versus UMEC and SAL [62].…”