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| Sponsor: | Aerovance, Inc. |
|---|---|
| Collaborator: |
Quintiles |
| Information provided by: | Aerovance, Inc. |
| ClinicalTrials.gov Identifier: | NCT00535028 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Asthma |
Drug: AER 001 Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration. |
| Enrollment: | 24 |
| Study Start Date: | January 2005 |
| Study Completion Date: | May 2005 |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
AER 001 s.c. once daily for 28 days
|
Drug: AER 001
AER 001 25 mgs s.c. once daily for 28 days
|
|
P: Placebo Comparator
placebo s.c. once daily for 28 days
|
Drug: placebo
sterile saline
|
Objectives:
Primary Objective
Methodology: Study Design:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
• Adult males and females > 18 years.
Exclusion Criteria:
• Subjects who do not conform to the above inclusion criteria.
Contacts and Locations| United Kingdom, LONDON | |
| 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. |
More Information
| Study ID Numbers: | QGUY/2004/IL4-13/-01, EUDRACT 2004-002836-25 |
| Study First Received: | September 21, 2007 |
| Last Updated: | September 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00535028 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
asthma allergy interleukin-4 interleukin-13 IL-4 |
IL-13 atopic late asthmatic response inflammation |
|
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |