ABSTRACT
Objective: To compare the efficacy and safety profiles of tiotropium/olodaterol with the mono-components in Chinese and total study population from TONADO trial. Methods: In the replicate, double-blind, parallel-group, active-controlled, randomized, 52-week, Phase â ¢ TONADO studies (TONADO 1+2), patients received tiotropium/olodaterol, tiotropium, or olodaterol via the Respimat(®) Inhaler (Boehringer Ingelheim, Germany). Primary end points were forced expiratory volume in 1 second (FEV(1)) area under the curve from 0 to 3 hours (AUC(0-3h)) response and trough FEV(1) response, and St George's respiratory questionnaire (SGRQ) total score at 24 weeks. Adverse events were also collected. This subgroup analysis only focused on the efficacy and safety of the drug at the approved dose in China. Results: 548 Chinese patients were randomized, aged 41 to 82 years [mean age, (63±8) years] and most were male (526, 96%), 111 received tiotropium/olodaterol 5/5 µg, and 127 received tiotropium 5 µg and 95 received olodaterol 5 µg. The baseline characteristics of these groups were similar. After 24 weeks, treatment with tiotropium/olodaterol 5/5 µg, tiotropium 5 µg and olodaterol 5 µg resulted in an adjusted mean FEV(1) AUC(0-3h) response of 0.240, 0.157 and 0.079 L, and trough FEV(1) response of 0.117, 0.068 and-0.001 L, respectively. Tiotropium/olodaterol 5/5 µg significantly improved SGRQ scores in Chinese patients compared with olodaterol 5 µg (32.729 and 37.202, respectively). Generally, the safety profile of tiotropium/olodaterol was comparable with mono-components in 52 weeks. Conclusion: Compared with tiotropium or olodaterol, tiotropium/olodaterol in Chinese patients provided significant improvement in lung function and quality of life, and the safety profiles were similar.
Subject(s)
Benzoxazines/administration & dosage , Bronchodilator Agents/administration & dosage , Pulmonary Disease, Chronic Obstructive/drug therapy , Quality of Life , Tiotropium Bromide/administration & dosage , Administration, Inhalation , Adrenergic beta-2 Receptor Agonists , Adult , Aged , Aged, 80 and over , Benzoxazines/therapeutic use , Bronchodilator Agents/therapeutic use , China/epidemiology , Double-Blind Method , Forced Expiratory Volume , Humans , Male , Middle Aged , Pulmonary Disease, Chronic Obstructive/ethnology , Pulmonary Disease, Chronic Obstructive/psychology , Tiotropium Bromide/therapeutic use , Treatment OutcomeABSTRACT
To investigate the effects of voluntary breathing on respiratory sinus arrhythmia and nonlinearity of heart rate variability (HRV), two kinds of voluntary breathing, speech and breath-holding, were used. The results showed that both types of voluntary breathing diminished the high frequency component of HRV, but speech decreased, while breath-holding enhanced the nonlinearity of HRV as detected by the Volterra series method. This finding indicates that respiratory patterns have a variety of influences on cardiovascular regulation.
