NCT01954628

Efficacy and Safety of AQX-1125 in Unstable COPD

The FLAGSHIP Study: A 12-week Phase II Study to Evaluate the Efficacy and Safety of AQX-1125 Following Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD) by Targeting the SHIP1 Pathway

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Aquinox Pharmaceuticals (Canada) Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide. Acute exacerbations of COPD are usually treated with steroids and/or antibiotics. Currently this conventional therapy has significant side effects including osteoporosis, cataracts and suppression of the immune system (from the steroids) and increasing bacterial resistance and other side effects from the use of antibiotics. During an acute exacerbation of COPD, the inflammation in the airways increases. AQX-1125 represents a new type drug that based current data is thought decrease the inflammatory process and therefore may provide a therapeutic benefit in the treatment of COPD.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	AQX-1125	Synthetic SHIP1 activator
DRUG	Placebo	Placebo control

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-07-01
• Completion: 2015-12-01
• First posted: 2013-10-07
• Last updated: 2017-06-12
• Results posted: 2017-06-12

Locations

8 sites across 8 countries: United States, Australia, Denmark, Finland, Hungary, New Zealand, Poland, Sweden