NCT01951222

Bronchodilator Properties and Safety in Asthma

Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA. V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	V0162
OTHER	Placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-09-26
• Last updated: 2014-09-17

Locations

1 site across 1 country: Germany