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A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)

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ClinicalTrials.gov Identifier: NCT00535028
Recruitment Status : Completed
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Sponsor:
Collaborator:
Quintiles, Inc.
Information provided by:
Aerovance, Inc.

Tracking Information
First Submitted Date  ICMJE September 21, 2007
First Posted Date  ICMJE September 26, 2007
Last Update Posted Date September 26, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IIa Study of Subcutaneous AER 001 on Antigen Challenge In Atopic Asthmatic Subjects (28 Day Study)
Official Title  ICMJE A Phase IIa Study To Investigate The Effects of AER 001 on Antigen Challenge In Atopic Asthmatic Subjects Following Repeated Administration.
Brief Summary 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Asthma
Intervention  ICMJE
  • Drug: AER 001
    AER 001 25 mgs s.c. once daily for 28 days
  • Drug: placebo
    sterile saline
Study Arms  ICMJE
  • Experimental: A
    AER 001 s.c. once daily for 28 days
    Intervention: Drug: AER 001
  • Placebo Comparator: P
    placebo s.c. once daily for 28 days
    Intervention: Drug: placebo
Publications * Wenzel S, Wilbraham D, Fuller R, Getz EB, Longphre M. Effect of an interleukin-4 variant on late phase asthmatic response to allergen challenge in asthmatic patients: results of two phase 2a studies. Lancet. 2007 Oct 20;370(9596):1422-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2007)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00535028
Other Study ID Numbers  ICMJE QGUY/2004/IL4-13/-01
EUDRACT 2004-002836-25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Aerovance, Inc.
Collaborators  ICMJE Quintiles, Inc.
Investigators  ICMJE
Principal Investigator: Darren Wilbraham, M.D. Guy's Drug Research Unit, Quintiles, Ltd.
PRS Account Aerovance, Inc.
Verification Date September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP