Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Study To Investigate The Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatic Subjects|
- To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics as measured by average percent fall in FEV1 from 4-10 hours post allergen challenge (i.e. the late phase response)after 28 days of treatment [ Time Frame: pre- vs. post 28 days of treatment ]
- 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. [ Time Frame: pre- vs. post 28 days of treatment ]
|Study Start Date:||December 2005|
|Study Completion Date:||October 2006|
Drug: AER 001
60 mg (in nebuliser), twice daily for 28 days
Other Name: AEROVANT
Placebo Comparator: P
Sterile saline nebulised, twice daily for 28 days
Primary Objective To investigate the effects of AER 001 on the late asthmatic response in mild to moderate asthmatics
- 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.
- 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
- 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).
|Guy's Drug Research Unit, Quintiles, Ltd.|
|London, United Kingdom, SE1 1YR|
|Principal Investigator:||Darren Wilbraham, MD||Guy's Drug Research Unit, Quintiles Ltd.|