- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00535028
A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)
September 21, 2007 updated by: Aerovance, Inc.
A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.
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 Overview
Detailed Description
Objectives:
Primary Objective
- 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
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
London
-
6 Newcomen Street London, London, United Kingdom, SE1 1YR
- Guy's Drug Research Unit, Quintiles, Ltd.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Adult males and females > 18 years.
- Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
- Subjects who have a pre study medical history, physical examination, 12 Lead ECG acceptable to the investigator.
- Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
- Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
- Subjects who are negative for drugs of abuse and alcohol tests at screening and admission.
- Positive response on screening to a skin prick test.
- Subjects who respond < 8 mg / mL on the methacholine challenge.
- Subjects, who on the Allergen challenge, have a PC20 on allergen and exhibit a late phase response (>or = 15% between 4-10h) following the allergen challenge.
- Subjects who have a FEV1 >70% of predicted.
- Have not received steroid treatment in the prior month.
- Subjects who are non-smokers for at least 3 months prior to screening.
- Have a < 10 pack year history.
- Satisfies the Global Initiative in Asthma (GINA, 2002) definition of asthma or have been on treatment for asthma.
- Subjects with stable, adequately treated medical conditions may be enrolled provided the Principal Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments without change during the study.
- Subjects who are able and willing to give written informed consent.
Exclusion Criteria:
• Subjects who do not conform to the above inclusion criteria.
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. Which would preclude antigen challenge
- Subjects who have a clinically relevant surgical history. Which would preclude antigen challenge
- Subjects who have a clinically relevant family history. Which would preclude antigen challenge
- Subjects who have a history of relevant drug hypersensitivity.
- Subjects who have a history of alcoholism.
- Subjects who have a history of drug abuse.
- Subjects who consume more than 28 units of alcohol a week. (unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer)
- Subjects who have a significant infection or known inflammatory process on screening.
- Subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
- Subjects who have an acute infection such as influenza at the time of screening and/or admission.
- Female subjects who are not using an acceptable method of contraception.
- Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
- Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
- Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
- Subjects who cannot communicate reliably with the investigator.
- Subjects who are unlikely to co-operate with the requirements of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
AER 001 s.c.
once daily for 28 days
|
AER 001 25 mgs s.c.
once daily for 28 days
|
Placebo Comparator: P
placebo s.c.
once daily for 28 days
|
sterile saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 28 days of treatment with study medication
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
After 28 days of treatment with study medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darren Wilbraham, M.D., Guy's Drug Research Unit, Quintiles, Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
September 21, 2007
First Submitted That Met QC Criteria
September 21, 2007
First Posted (Estimate)
September 26, 2007
Study Record Updates
Last Update Posted (Estimate)
September 26, 2007
Last Update Submitted That Met QC Criteria
September 21, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QGUY/2004/IL4-13/-01
- EUDRACT 2004-002836-25
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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