Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics
|ClinicalTrials.gov Identifier: NCT00535431|
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
|Condition or disease||Intervention/treatment||Phase|
|Allergic Asthma||Drug: AER 001 Drug: placebo||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Study To Investigate The Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatic Subjects|
|Study Start Date :||December 2005|
|Actual 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535431
|Guy's Drug Research Unit, Quintiles, Ltd.|
|London, United Kingdom, SE1 1YR|
|Principal Investigator:||Darren Wilbraham, MD||Guy's Drug Research Unit, Quintiles Ltd.|