Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a randomized Phase III study conducted in Asia, Europe, and the USA

Brian J. Lipworth (Lead / Corresponding author), David J. Collier, Yasuhiro Gon, Nanshan Zhong, Koichi Nishi, Rongchang Chen, Samir Arora, Andrea Maes, Shahid Siddiqui, Colin Reisner, Ubaldo J. Martin

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Abstract

Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.

Methods: In this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with 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. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed.

Results: Of the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2 years, 74.1% male, and 40.2% Asian). GFF MDI significantly improved morning predose trough FEV1 at Week 24 (primary endpoint) vs placebo MDI, GP MDI, and FF MDI (least squares mean differences: 165, 59, and 72 mL, respectively; all P<0.0001). GFF MDI also significantly improved other lung function endpoints vs placebo MDI, GP MDI, and FF MDI and patient-reported outcomes vs placebo MDI and GP MDI. A larger proportion of patients treated with GFF MDI achieved the minimum clinically important difference in Transition Dyspnea Index score vs GP MDI and placebo MDI and in St George's Respiratory Questionnaire score vs placebo MDI. Adverse event rates were similar across treatment groups.

Conclusion: These results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.

Original languageEnglish
Pages (from-to)2969-2984
Number of pages16
JournalInternational Journal of Chronic Obstructive Pulmonary Disease
Volume13
DOIs
Publication statusPublished - 26 Sep 2018

Fingerprint

Glycopyrrolate
Metered Dose Inhalers
Chronic Obstructive Pulmonary Disease
Suspensions
Technology
Lung
Placebos
Patient Reported Outcome Measures
Formoterol Fumarate
Safety

Keywords

  • β2 -agonist
  • bronchodilator
  • COPD
  • co-suspension delivery technology
  • muscarinic antagonist
  • β2-agonist

Cite this

Lipworth, Brian J. ; Collier, David J. ; Gon, Yasuhiro ; Zhong, Nanshan ; Nishi, Koichi ; Chen, Rongchang ; Arora, Samir ; Maes, Andrea ; Siddiqui, Shahid ; Reisner, Colin ; Martin, Ubaldo J. / Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD : a randomized Phase III study conducted in Asia, Europe, and the USA. In: International Journal of Chronic Obstructive Pulmonary Disease. 2018 ; Vol. 13. pp. 2969-2984.
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abstract = "Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.Methods: In this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with 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. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed.Results: Of the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2 years, 74.1{\%} male, and 40.2{\%} Asian). GFF MDI significantly improved morning predose trough FEV1 at Week 24 (primary endpoint) vs placebo MDI, GP MDI, and FF MDI (least squares mean differences: 165, 59, and 72 mL, respectively; all P<0.0001). GFF MDI also significantly improved other lung function endpoints vs placebo MDI, GP MDI, and FF MDI and patient-reported outcomes vs placebo MDI and GP MDI. A larger proportion of patients treated with GFF MDI achieved the minimum clinically important difference in Transition Dyspnea Index score vs GP MDI and placebo MDI and in St George's Respiratory Questionnaire score vs placebo MDI. Adverse event rates were similar across treatment groups.Conclusion: These results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.",
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Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD : a randomized Phase III study conducted in Asia, Europe, and the USA. / Lipworth, Brian J. (Lead / Corresponding author); Collier, David J.; Gon, Yasuhiro; Zhong, Nanshan; Nishi, Koichi; Chen, Rongchang; Arora, Samir; Maes, Andrea; Siddiqui, Shahid; Reisner, Colin; Martin, Ubaldo J.

In: International Journal of Chronic Obstructive Pulmonary Disease, Vol. 13, 26.09.2018, p. 2969-2984.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Improved lung function and patient-reported outcomes with co-suspension delivery technology glycopyrrolate/formoterol fumarate metered dose inhaler in COPD

T2 - a randomized Phase III study conducted in Asia, Europe, and the USA

AU - Lipworth, Brian J.

AU - Collier, David J.

AU - Gon, Yasuhiro

AU - Zhong, Nanshan

AU - Nishi, Koichi

AU - Chen, Rongchang

AU - Arora, Samir

AU - Maes, Andrea

AU - Siddiqui, Shahid

AU - Reisner, Colin

AU - Martin, Ubaldo J.

PY - 2018/9/26

Y1 - 2018/9/26

N2 - Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.Methods: In this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with 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. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed.Results: Of the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2 years, 74.1% male, and 40.2% Asian). GFF MDI significantly improved morning predose trough FEV1 at Week 24 (primary endpoint) vs placebo MDI, GP MDI, and FF MDI (least squares mean differences: 165, 59, and 72 mL, respectively; all P<0.0001). GFF MDI also significantly improved other lung function endpoints vs placebo MDI, GP MDI, and FF MDI and patient-reported outcomes vs placebo MDI and GP MDI. A larger proportion of patients treated with GFF MDI achieved the minimum clinically important difference in Transition Dyspnea Index score vs GP MDI and placebo MDI and in St George's Respiratory Questionnaire score vs placebo MDI. Adverse event rates were similar across treatment groups.Conclusion: These results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.

AB - Background: COPD is a major global cause of mortality and morbidity. PINNACLE-4 evaluated the efficacy and safety of GFF MDI (glycopyrrolate/formoterol fumarate metered dose inhaler) in patients from Asia, Europe, and the USA with moderate-to-very severe COPD.Methods: In this double-blind, placebo-controlled, Phase III study, patients were randomized to treatment with 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. Lung function, patient-reported outcomes (symptoms and health-related quality of life), and safety were assessed.Results: Of the 1,756 patients randomized, 1,740 patients were included in the intent-to-treat population (mean age 64.2 years, 74.1% male, and 40.2% Asian). GFF MDI significantly improved morning predose trough FEV1 at Week 24 (primary endpoint) vs placebo MDI, GP MDI, and FF MDI (least squares mean differences: 165, 59, and 72 mL, respectively; all P<0.0001). GFF MDI also significantly improved other lung function endpoints vs placebo MDI, GP MDI, and FF MDI and patient-reported outcomes vs placebo MDI and GP MDI. A larger proportion of patients treated with GFF MDI achieved the minimum clinically important difference in Transition Dyspnea Index score vs GP MDI and placebo MDI and in St George's Respiratory Questionnaire score vs placebo MDI. Adverse event rates were similar across treatment groups.Conclusion: These results demonstrated the efficacy of GFF MDI in patients with moderate-to-very severe COPD. GFF MDI was well tolerated, with a safety profile commensurate with long-acting bronchodilators.

KW - β2 -agonist

KW - bronchodilator

KW - COPD

KW - co-suspension delivery technology

KW - muscarinic antagonist

KW - β2-agonist

U2 - 10.2147/COPD.S171835

DO - 10.2147/COPD.S171835

M3 - Article

C2 - 30310273

VL - 13

SP - 2969

EP - 2984

JO - International Journal of Chronic Obstructive Pulmonary Disease

JF - International Journal of Chronic Obstructive Pulmonary Disease

SN - 1176-9106

ER -