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Effects of AER 001 Administered by Nebulization on Antigen Challenge in Atopic Asthmatics

NCT00535431 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2007-09-26

No results posted yet for this study

Summary

This is a single centre, double-blind, randomised, parallel group, repeated dose asthmatic subjects. Subjects will receive AER 001 (60 mgs) or placebo twice daily for 28 days. Before and after treatment subjects will be experimentally challenged with inhaled allergen to induce decreases in lung function. The primary outcome is late phase response to allergen as measured by the average percent change in FEV1 from 4-10 hours following allergen. Because AER 001 is a Th2 anti-inflammatory, it is hypothesized that AER 001 treatment will inhibit the late phase response to allergen challenge.

Conditions

  • Allergic Asthma

Interventions

DRUG

AER 001

60 mg (in nebuliser), twice daily for 28 days

DRUG

placebo

Sterile saline nebulised, twice daily for 28 days

Sponsors & Collaborators

  • Aerovance, Inc.

    lead INDUSTRY

Principal Investigators

  • Darren Wilbraham, MD · 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
2005-12-31
Completion
2006-10-31

Countries

  • United Kingdom

Study Locations

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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 NCT00535431 on ClinicalTrials.gov