NCT00535431

Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics

A Study To Investigate The Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatic Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Aerovance, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before and after treatment subjects will be experimentally challenged with inhaled allergen to induce decreases in lung function. The primary outcome is late phase response to allergen as measured by the average percent change in FEV1 from 4-10 hours following allergen. Because AER 001 is a Th2 anti-inflammatory, it is hypothesized that AER 001 treatment will inhibit the late phase response to allergen challenge.

Detailed description

Objectives: Primary Objective To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics Secondary Objectives * To examine the effects of AER 001 on antigen induced airway hyperactivity to adenosine monophosphate and blood levels of circulating IgE. * To characterise the pharmacokinetics of nebulised AER 001. Exploratory Objectives * To examine the effects of AER 001 on circulating sIL-13Rα2 and IFNgamma. * To examine the results of single nucleotide polymorphism (SNP) analysis of IL-4, IL-13, IL-4Rα and IL-13R α to determine if there is any correlation between AER 001 response and genotype * To examine levels of anti-AER 001 following administration of AER 001 Methodology: * Single centre, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects. * A sufficient number of subjects (at least 30 subjects) will be recruited to ensure that at least 26 completed sets of data will be obtained. * Subjects will be randomised to receive either AER 001 60 mg / matched volume Placebo in a ratio of 1 active : 1 placebo ( block size of 6). * Treatments will be administered by nebulization from a PARI LC Plus nebulizer * Subjects are to receive b.i.d. administration of AER 001 / placebo for 27 days. A morning dose will be given on Day 28, (24 hours after Day 27 am-dose).

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	AER 001	60 mg (in nebuliser), twice daily for 28 days
DRUG	placebo	Sterile saline nebulised, twice daily for 28 days

Timeline

• Start date: 2005-12-01
• Completion: 2006-10-01
• First posted: 2007-09-26
• Last updated: 2007-09-26

Locations

1 site across 1 country: United Kingdom