A Phase IIa Study To Investigate The Effects of AER 001on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration. - N/A
- Conditions
- Asthma is characterised by an infiltration of the bronchial mucosa with activated T-lymphocytes (T-cells), eosinophils, and to a lessor extent polymorphonuclear leukocytes.
- Registration Number
- EUCTR2004-002836-25-GB
- Lead Sponsor
- Aerovance Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
•Adult males and females > 18 years.
•Subjects who if female, 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.
•Regular or PRN use treatment of ß agonists.
•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 PC25 on allergen and exhibit a late phase response (>or = 10% 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? 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 prescription drugs within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor. ? need
? Subjects who have used over the counter medication excluding routine vitamins but including mega dose vitamin therapy within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor. ?need
? Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
? 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary Objective<br>? To investigate the late asthmatic response.<br><br>;Secondary Objective: Secondary Objectives<br>? To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.<br>;Primary end point(s): Investigate the late response in asthmatics.<br><br>Effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia.<br>
- Secondary Outcome Measures
Name Time Method