Study of Daclizumab in Patients With Chronic, Persistent Asthma

March 9, 2012 updated by: Facet Biotech

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma

The purpose of the study is to evaluate an investigational medication to treat chronic persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-month period. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Medical Research Associates
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • San Diego, California, United States, 92120
        • Institute of Health Care Assessment, Inc.
      • Stockton, California, United States, 95207
        • Bensch Research Associates
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
      • Denver, Colorado, United States, 80230
        • Clinical Reserch Centers of Colorado
    • Florida
      • Miami, Florida, United States, 33176
        • Florida Center for Allergy and Asthma Reserch
    • Georgia
      • Woodstock, Georgia, United States, 30188
        • Rx Research
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • ICSL Clinical Studies
      • River Forest, Illinois, United States, 60305
        • Asthma and Allergy Center of Chicago, S.C.
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • New England Clinical Studies
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Center for Clinical Research
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Allergy, Asthma, and Dermatology Research Center, LLC
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Valley Clinical Research Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Pharmaceutical Research and Consulting, Inc.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Medical School
      • Milwaukee, Wisconsin, United States, 53209
        • Allergy and Respiratory Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of asthma for 6 or more months
  • History of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment

Exclusion Criteria:

  • Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment
  • No significant disease other than asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Facet Biotech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

December 19, 2001

First Submitted That Met QC Criteria

December 19, 2001

First Posted (Estimate)

December 20, 2001

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAC-1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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