MedTrace Logo

A Study of the Treatment-Sparing Effects of AEROVANT™ AER 001 Inhalation Powder in Asthma Patients, AEROTRIAL

NCT00801853 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2011-01-27

No results posted yet for this study

Summary

A multi-center, Phase IIb, double-blind, randomized, placebo controlled, parallel-group, repeated-dose study in male and female patients with moderate to severe asthma in which patients will be stabilized on AEROVANT then doses of inhaled corticosteroids and LABA will be tapered. The hypothesis is that AEROVANT will improve asthma symptom control and decrease the need for inhaled corticosteroids and LABA, thus improving exacerbation incidence compared to placebo. Incidence of asthma exacerbation is the primary endpoint.

Conditions

Interventions

DRUG

Aerovant

Aerovant 1mg bid (dry powder)

DRUG

Aerovant

Aerovant 3mg bid (dry powder)

DRUG

Aerovant

Aerovant 10mg bid (dry powder)

OTHER

placebo

placebo control (dry powder)

Sponsors & Collaborators

  • Aerovance, Inc.

    lead INDUSTRY

Principal Investigators

  • Sally Wenzel, M.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Hungary
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00801853 on ClinicalTrials.gov