NCT00861211

Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess The Safety and Efficacy of Two Weeks of Oral Senicapoc Administration on Allergen Challenge in Atopic Asthmatic Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Icagen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether senicapoc can decrease changes in FEV1 following allergen challenge in atopic allergic subjects.

Detailed description

Based on the unmet medical need for new agents in the treatment of asthma and the role of KCa3.1 in the function of several different cell types involved in the inflammatory response, and the effects seen in an animal model of allergic asthma, it is reasonable to explore the utility of senicapoc, a KCa3.1 blocker, as a novel treatment of asthma. This study will test the ability of senicapoc to alleviate bronchospasm induced by an allergen challenge in patients with allergic asthma. It is analogous to the study performed in animals in which senicapoc demonstrated the ability to reduce airway resistance and hyper-responsiveness induced by airway challenge with antigen and carbachol, respectively. This study is also the first to test the ability of senicapoc to reduce airway inflammation, which is the key pathophysiologic process in asthma. In summary, with a demonstrated safety profile across a wide range of doses in humans and efficacy in an animal model of allergic bronchospasm and hyper-responsiveness, the initiation of exploratory studies of senicapoc for treatment of asthma is justified.

Conditions

• Atopic Asthma

Interventions

Type	Name	Description
DRUG	senicapoc	Loading Dose: 80 mg twice daily x 3 days followed by Maintenance Dose: 40 mg daily x 11 days
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2009-03-13
• Last updated: 2011-07-14

Locations

2 sites across 1 country: United Kingdom