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

NCT00535028 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2007-09-26

No results posted yet for this study

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).

Conditions

  • Allergic Asthma

Interventions

DRUG

AER 001

AER 001 25 mgs s.c. once daily for 28 days

DRUG

placebo

sterile saline

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Aerovance, Inc.

    lead INDUSTRY

Principal Investigators

  • Darren Wilbraham, M.D. · Guy's Drug Research Unit, Quintiles, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Completion
2005-05-31

Countries

  • United Kingdom

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00535028 on ClinicalTrials.gov