A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)
This is a single center, double-blind, randomised parallel group design study to investigate the effects of AER 001 on the late phase asthmatic resonse in asthmatic subjects. AER 001 is to be administered subcutaneously (25 mg, once daily) for 28 days. The asthmatic subjects will be challenged with allergen both before and after AER 001 treatment (at screen and at Day 28). The primary outcome will be late phase sthmatic response (the max drop in FEV1 from 4-10 hours after an 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 Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.|
- Max %fall in FEV1 during the late phase asthmatic response (4-10 hours after allergen challenge) [ Time Frame: After 28 days of treatment with study medication ]
- To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia. [ Time Frame: After 28 days of treatment with study medication ]
|Study Start Date:||January 2005|
|Study Completion Date:||May 2005|
AER 001 s.c. once daily for 28 days
Drug: AER 001
AER 001 25 mgs s.c. once daily for 28 days
Placebo Comparator: P
placebo s.c. once daily for 28 days
- To investigate the late asthmatic response in mild to moderate asthmatics.. Secondary Objectives
- To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.
Methodology: Study Design:
- Single centre, phase IIa, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects.
- A sufficient number of subjects (at least 24 subjects) will be recruited to ensure that at least 20 completed sets of data will be obtained.
- Subjects will be randomised to receive either AER 001 25 mg / Placebo in a ratio of 1 active : 1 placebo.
- Treatments will be administered as a sub-cutaneous injection.
- Subjects are to receive a daily administration of AER 001 / placebo over a 4 week period.
- Subjects will be admitted to the unit at least 2 hours prior to the first dose administration. On the first dosing occasion the subjects will remain in the unit under clinical supervision for at least 30 minutes post dose or until the Investigator is satisfied for them to be discharged. On subsequent dosing days the subjects will be admitted to the unit at least 45 minutes prior to dosing and remain in the unit for at least 15 minutes post dose or until the Investigator is satisfied for them to be discharged.
|Guy's Drug Research Unit, Quintiles, Ltd.|
|6 Newcomen Street London, London, United Kingdom, SE1 1YR|
|Principal Investigator:||Darren Wilbraham, M.D.||Guy's Drug Research Unit, Quintiles, Ltd.|