A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)
|ClinicalTrials.gov Identifier: NCT00535028|
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.|
|Study Start Date :||January 2005|
|Actual 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535028
|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.|