ADOAIR250 Anti-inflammatory Effects in Japanese Subjects With Chronic Obstructive Pulmonary Disease

Summary

The study will be conducted in a respiratory specialist institute in Japan, with standardized techniques and data assurance checks to optimize data quality. The licensed dosage and administration of Adoair in Japan will be applied in this study. Each subject will receive treatment options in a randomized blinded fashion. Subjects will be randomized following a 4-week wash-out phase to take either Adoair 50/250mcg twice daily or placebo twice daily for 12 weeks.

Timeline

Start

2012-05

Primary completion

2013-07

Completion

2013-07

Outcome

Missed primary endpoint

paper SFC 250 did not significantly reduce sputum neutrophils compared with placebo PMID 25945045 ↗

Publications

• Asai K, Kobayashi A, Makihara Y, Johnson M. Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Apr 17;10:803-11. doi: 10.2147/COPD.S79842. eCollection 2015.

Drugs

Indications