Efficacy and Safety of Formoterol in Japanese Patients with COPD

Minakata, Yoshiaki; Iijima, Hiroaki; Takahashi, T; Miura, Motohiko; Ogawa, Hiroyasu; Kimura, Keiji; Koga, Takeharu; Kinoshita, Masaharu; Tsuda, Tohru; Aizawa, Hisamichi; Ichinose, Masakazu

doi:10.2169/internalmedicine.47.0494

Cited by 7 publications

(5 citation statements)

References 21 publications

(12 reference statements)

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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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“…27,28 However, in clinical studies investigating the use of LABAs in COPD patients, there are several reports that demonstrate similar response in Japanese and Caucasian populations. 29,30 In previous studies in the Caucasian population, indacaterol has shown a fast onset of action, similar to that of salbutamol (a short-acting beta-2 agonist) and faster than salmeterol. 18 The results of our study are also consistent with these findings, as significant improvements in FEV 1 appeared as early as 5 min post-indacaterol dose (the earliest time point evaluated), with all indacaterol doses showing statistical superiority (P < 0.05) to salmeterol until at least 30 min post-dose.…”

Section: Discussionmentioning

confidence: 91%

24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol

Sugihara¹,

Kanada

Haida

et al. 2010

Respiratory Medicine

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“…The prevalence of COPD in Japan and other Asian countries has been estimated to be in the region of 10% among adults aged >40 years and >20% in those with a history of smoking . The efficacy and safety of formoterol alone in Japanese patients with moderate to severe COPD has recently been reported …”

Section: Introductionmentioning

confidence: 99%

Budesonide/formoterol via Turbuhaler® versus formoterol via Turbuhaler® in patients with moderate to severe chronic obstructive pulmonary disease: Phase III multinational study results

Fukuchi

Samoro²,

Фассахов

et al. 2013

Respirology

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Efficacy and Safety of Formoterol in Japanese Patients with COPD

Cited by 7 publications

References 21 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>

24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: A comparison with placebo and salmeterol

Budesonide/formoterol via Turbuhaler® versus formoterol via Turbuhaler® in patients with moderate to severe chronic obstructive pulmonary disease: Phase III multinational study results

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