Dose Finding Study of Nemiralisib (GSK2269557) in Subjects With an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

NCT03345407 PHASE2 TERMINATED Results posted

Nemiralisib is being developed as an anti-inflammatory drug for the treatment of inflammatory airways disease. This study is designed to assess the dose response, efficacy, safety, and pharmacokinetics of nemiralisib across a range of doses \[up to 750 micrograms (µg)\] compared with placebo. The study consists of a Screening Period, a 12-Week Treatment Period and a 12-Week Post-Treatment Follow-Up Period. Approximately 1,250 subjects with an acute moderate or severe exacerbation of COPD requiring standard of care (SoC) therapy will be randomized in this double-blind study. Subjects will be randomized to receive different doses of nemiralisib or placebo via ELLIPTA® inhaler. The total duration of study participation is approximately 6 months (170 days). ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE2
Status	TERMINATED
Enrolment	943
Start date	Tue Nov 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Jan 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

• Placebo ELLIPTA
• Nemiralisib ELLIPTA 50 µg
• Nemiralisib ELLIPTA 100 µg
• Nemiralisib ELLIPTA 250 µg
• Nemiralisib ELLIPTA 500 µg
• Nemiralisib ELLIPTA 750 µg
• Albuterol (Salbutamol) MDI or nebules
• Standard of care therapy

Countries

France, Italy, Netherlands, Russia, Sweden, United Kingdom, Germany, Poland, Mexico, South Korea, Argentina, Canada, Romania, Australia, United States, Spain