Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease

Bai, Chunxue; Ichinose, Masakazu; Lee, Sang Haak; Lee, Kwan Ho; Jöns, Olaf; Bothner, Ulrich; Zhao, Yihua; Buhl, Roland

doi:10.2147/copd.s137719

Cited by 12 publications

(12 citation statements)

References 26 publications

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“…The safety profile of GFF MDI in patients from China was generally consistent with the global patient population 13 and also with the safety profiles of other LAMA/LABA FDCs in predominantly Caucasian patient populations. [24][25][26][27] In line with our results, previous studies of glycopyrrolate or formoterol fumarate, [28][29][30] as well as other LAMA/LABA FDCs, [31][32][33] have also found that treatment effects and safety outcomes were generally similar between Asian and predominantly Caucasian patient populations.…”

Section: Discussionsupporting

confidence: 90%

<p>Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD</p>

Chen

Zhong

Wang

et al. 2020

COPD

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Background: Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) is a long-acting muscarinic antagonist/long-acting β 2-agonist fixed-dose combination therapy delivered by MDI, formulated using innovative co-suspension delivery technology. The PINNACLE-4 study evaluated the efficacy and safety of GFF MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) from Asia, Europe, and the USA. This article presents the results from the China subpopulation of PINNACLE-4. Methods: In this randomized, double-blind, placebo-controlled, parallel-group Phase III study (NCT02343458), patients received GFF MDI 18/9.6 µg, glycopyrrolate (GP) MDI 18 µg, formoterol fumarate (FF) MDI 9.6 µg, or placebo MDI (all twice daily) for 24 weeks. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 second at Week 24. Secondary lung function endpoints and patient-reported outcome measures were also assessed. Safety was monitored throughout the study. Results: Overall, 466 patients from China were included in the intent-to-treat population (mean age 63.6 years, 95.7% male). Treatment with GFF MDI improved the primary endpoint compared to GP MDI, FF MDI, and placebo MDI (least squares mean differences: 98, 104, and 173 mL, respectively; all P≤0.0001). GFF MDI also improved daily total symptom scores and time to first clinically important deterioration versus monocomponents and placebo MDI, and Transition Dyspnea Index focal score versus placebo MDI. Rates of treatment-emergent adverse events were similar across the active treatment groups and slightly higher in the placebo MDI group. Conclusion: GFF MDI improved lung function and daily symptoms versus monocomponents and placebo MDI and improved dyspnea versus placebo MDI. All treatments were well tolerated with no unexpected safety findings. Efficacy and safety results were generally consistent with the global PINNACLE-4 population, supporting the use of GFF MDI in patients with COPD from China.

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Section: Discussionsupporting

confidence: 90%

<p>Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD</p>

Chen

Zhong

Wang

et al. 2020

COPD

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“…Results in Asian patients were generally consistent with those seen in the overall clinical trial population. In a prespecified exploratory analysis of TOnado 1 and 2, FEV 1 AUC 0–3 and trough FEV 1 responses at 24 weeks were significantly ( p < 0.0001) greater with tiotropium/olodaterol than with tiotropium and olodaterol in the East Asian subpopulation ( n = 709) [26]. Similarly, in the Japanese subpopulation of TOnado 1 and 2 ( n = 413), FEV 1 AUC 0–3 and trough FEV 1 responses at 24 weeks were greater (nominal p < 0.0001) with tiotropium/olodaterol than with tiotropium and olodaterol [27].…”

Section: Therapeutic Efficacy Of Tiotropium/olodaterolmentioning

confidence: 99%

“…Tiotropium/olodaterol was generally well tolerated in Asian patients with moderate to very severe COPD [26–29, 35]. No important safety concerns were identified in a 52-week, randomized, double-blind, multicentre trial investigating the long-term safety of tiotropium/olodaterol in Japanese patients aged ≥ 40 years ( n = 122) [35].…”

Section: Tolerability Of Tiotropium/olodaterolmentioning

confidence: 99%

Tiotropium/Olodaterol: A Review in COPD

Blair

2019

Drugs

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Tiotropium/olodaterol (Stiolto ® Respimat ® ; Spiolto ® Respimat ® ) is an inhaled fixed-dose combination of the long-acting muscarinic antagonist tiotropium bromide (hereafter referred to as tiotropium) and the long-acting β 2 -adrenergic agonist olodaterol. It is available in several countries, including the USA, Japan, China and those of the EU, where it is indicated for the long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). The efficacy of tiotropium/olodaterol 5/5 μg/day in patients with COPD was evaluated in phase III or IV trials of 6–52 weeks’ duration. Tiotropium/olodaterol improved lung function to a greater extent than each of its individual components or placebo in 12- and 52-week trials. In 6-week trials, tiotropium/olodaterol provided greater lung function benefits over 24 h than the individual components, placebo or twice-daily fluticasone propionate/salmeterol. Tiotropium/olodaterol also demonstrated beneficial effects on health-related quality of life (HR-QoL), dyspnoea, inspiratory capacity, exercise endurance and the need for rescue medication. In an 8-week open-label trial, umeclidinium/vilanterol was superior to tiotropium/olodaterol for the primary endpoint of trough forced expiratory volume in 1 s. The tolerability profile of tiotropium/olodaterol was generally similar to that of the individual components. In conclusion, tiotropium/olodaterol provides a useful option for the maintenance treatment of COPD, with the convenience of once-daily administration via a single inhaler.

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“…Olodaterol/tiotropium 5/5 μg was superior to each monotherapy for lung function and SGRQ in the Japanese subpopulation of patients with COPD from the TONADO study [133]. A phase III study in an East Asian population showed slightly greater trough FEV 1 treatment differences between olodaterol/tiotropium 5/5 μg and tiotropium compared to the overall population [134]. The VESUTO ® study investigated efficacy of olodaterol/tiotropium compared with tiotropium alone on inspiratory capacity, exercise capacity, and daily physical activity in Japanese patients with COPD.…”

Section: Fixed-dose Combinations Of Long-acting Bronchodilators For Copdmentioning

confidence: 99%

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives

2019

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Maintenance bronchodilator therapy with long-acting β-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) is the cornerstone treatment for patients with stable chronic obstructive pulmonary disease (COPD). Fixed-dose combinations (FDCs) of LABA/LAMA are recommended for the majority of symptomatic COPD patients by global guidelines; regional guidelines such as the Japanese and Korean guidelines also provide similar recommendations for the use of LABA/LAMA FDCs. This review comprehensively describes the latest clinical evidence from key studies on the efficacy and safety of four approved LABA/LAMA fixed-dose combinations: indacaterol/glycopyrronium, vilanterol/umeclidinium, formoterol/aclidinium, and olodaterol/tiotropium. Additionally, in this review we describe the rationale behind the use of LABA/LAMA FDC therapy, key findings from the preclinical and clinical trial evaluation of respective LABA and LAMA monocomponents, and the efficacy and safety of LABA/LAMA FDCs. Special emphasis is placed on the clinical evidence for the monocomponents and LABA/LAMA FDCs from the Asian population. This detailed overview of the efficacy and safety of LABA/LAMA FDCs in global and Asian COPD patients is envisaged to provide a better understanding of the benefits of these therapies and to inform healthcare providers and patients on their appropriate use.Funding: Novartis Pharma K.K.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-0893-3) contains supplementary material, which is available to authorized users.

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Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease

Cited by 12 publications

References 26 publications

<p>Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD</p>

<p>Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD</p>

Tiotropium/Olodaterol: A Review in COPD

Fixed-Dose Combinations of Long-Acting Bronchodilators for the Management of COPD: Global and Asian Perspectives

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