Abstract
BackgroundAs lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Post hoc analyses were performed to assess the benefits for patients according to disease severity and treatment history.MethodsFour subgroup analyses were performed: Global initiative for chronic Obstructive Lung Disease (GOLD) 2/3, GOLD A/B/C/D, treatment naive/not treatment naive and receiving inhaled corticosteroids (ICS) at baseline/not receiving ICS at baseline. Primary end points were change in forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h response, change in trough FEV1 and St George’s Respiratory Questionnaire (SGRQ) total score. Transition Dyspnoea Index (TDI) focal score was a secondary end point, and SGRQ and TDI responder analyses were further end points; all were assessed at 12 weeks.ResultsIn all subgroups, patients receiving tiotropium + olodaterol responded better overall than those receiving tiotropium monotherapy. Improvements with tiotropium + olodaterol over placebo or tiotropium monotherapy were noted across GOLD 2/3 and GOLD A/B/C/D; however, improvements in SGRQ total score were most evident in the GOLD B subgroup. Moreover, lung-function outcomes were generally greater in those patients who had been receiving previous long-acting bronchodilator and/or ICS maintenance treatment.ConclusionsThese data suggest that tiotropium + olodaterol should be considered as a treatment option in patients with moderate COPD who are initiating maintenance therapy, as well as those with more severe disease.Trial registrationClinicalTrials.gov: NCT01964352 and NCT02006732.Electronic supplementary materialThe online version of this article (doi:10.1186/s12931-016-0387-7) contains supplementary material, which is available to authorized users.
Highlights
As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest
A recent post hoc analysis of the TONADO® studies showed that tiotropium + olodaterol significantly improved lung function in Global initiative for chronic Obstructive Lung Disease (GOLD) severity groups 2, 3 and 4, compared to monotherapy, irrespective of whether patients had received prior long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) maintenance treatment [19]
Efficacy GOLD 2 and 3 subgroups Trough forced expiratory volume in 1 s (FEV1) responses and St George’s Respiratory Questionnaire (SGRQ) total scores improved with tiotropium + olodaterol in both GOLD 2 and 3 subgroups after 12 weeks of treatment compared to baseline (Figs. 2 and 3)
Summary
As lung function declines rapidly in the early stages of chronic obstructive pulmonary disease (COPD), the effects of bronchodilators in patients with moderate disease and those who have not previously received maintenance therapy are of interest. OTEMTO® 1 and 2 were two replicate, 12-week, Phase III studies investigating the benefit of tiotropium + olodaterol on lung function and quality of life in patients with moderate to severe disease. Tiotropium is an established once-daily LAMA that improves lung function, patient-reported outcomes such as dyspnoea and quality of life, and reduces exacerbations in patients with COPD [3,4,5,6,7,8,9]. A recent post hoc analysis of the TONADO® studies showed that tiotropium + olodaterol significantly improved lung function in Global initiative for chronic Obstructive Lung Disease (GOLD) severity groups 2, 3 and 4, compared to monotherapy, irrespective of whether patients had received prior LAMA or LABA maintenance treatment [19]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
