1. Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD
- Author
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Fukushima Y, Nakatani Y, Ide Y, Sekino H, St Rose E, Siddiqui S, Maes A, and Reisner C
- Subjects
bronchodilator agents ,dose-response relationship ,forced expiratory volume ,metered dose inhalers ,chronic obstructive pulmonary disease. ,Diseases of the respiratory system ,RC705-779 - Abstract
Yasushi Fukushima,1 Yuji Nakatani,2 Yumiko Ide,3 Hisakuni Sekino,4 Earl St Rose,5 Shahid Siddiqui,6 Andrea Maes,5 Colin Reisner5,6 1Department of Internal Medicine, Fukuwa Clinic, Tokyo, Japan; 2Department of Internal Medicine, Nakatani Hospital, Hyogo, Japan; 3Department of Internal Medicine, Tokyo Center Clinic, Tokyo, Japan; 4Department of Internal Medicine, Sekino Hospital, Tokyo, Japan; 5Pearl – a member of the AstraZeneca Group, Morristown, NJ, USA; 6AstraZeneca, Gaithersburg, MD, USA Purpose: Due to the burden of COPD in Japan, new pharmacologic treatments are needed to meet patient requirements. This study assessed the efficacy and safety of glycopyrronium (GP) delivered via metered dose inhaler (MDI) in Japanese patients with moderate-to-severe COPD.Methods: This Phase IIb, multicenter, randomized, double-blind, 7-day, crossover study compared GP MDI 28.8, 14.4, and 7.2 µg with placebo MDI (all administered as two inhalations, twice daily). The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) on Day 8. Secondary endpoints included FEV1 area under the curve from 0 to 2 hours (AUC0–2) and peak change from baseline in FEV1 on Days 1 and 8 and forced vital capacity AUC0–2 on Day 8. Safety was also assessed. ClinicalTrials.gov Identifier: NCT03256552; http://www.ClinicalTrials.gov.Results: Sixty-six patients were randomized and 62 were included in the modified intent-to-treat population (mean age 67.5 years). All three GP MDI doses significantly improved change from baseline in morning pre-dose trough FEV1 on Day 8 compared with placebo MDI (least squares mean differences 108–131 mL; all p
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- 2018