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Study of Daclizumab in Patients with Chronic, Persistent Asthma - Article


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Daclizumab Injection

Zenapax


Clinical Trial: Study of Daclizumab in Patients with Chronic, Persistent Asthma

This study is no longer recruiting patients.

Sponsored by: Protein Design Labs
Information provided by: Protein Design Labs

Purpose

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.

Condition Treatment or Intervention Phase
Asthma
 Drug: Daclizumab
Phase II

MedlinePlus related topics:  Asthma

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  120

Study start: September 2001

Eligibility

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

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

Location Information


California
      Bensch Research Associates, Stockton,  California,  95207,  United States

      Southern California Research, Mission Viejo,  California,  92691,  United States

      Institute of Health Care Assessment, Inc., San Diego,  California,  92120,  United States

      Medical Research Associates, Long Beach,  California,  90806,  United States

Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States

      Clinical Reserch Centers of Colorado, Denver,  Colorado,  80230,  United States

Florida
      Florida Center for Allergy and Asthma Reserch, Miami,  Florida,  33176,  United States

Georgia
      Rx Research, Woodstock,  Georgia,  30188,  United States

Illinois
      ICSL Clinical Studies, Bloomington,  Illinois,  61704,  United States

      Asthma and Allergy Center of Chicago, S.C., River Forest,  Illinois,  60305,  United States

Massachusetts
      New England Clinical Studies, North Dartmouth,  Massachusetts,  02747,  United States

Minnesota
      Clinical Research Institute, Minneapolis,  Minnesota,  55402,  United States

New Jersey
      Princeton Center for Clinical Research, Princeton,  New Jersey,  08540,  United States

Oregon
      Allergy, Asthma, and Dermatology Research Center, LLC, Lake Oswego,  Oregon,  97035,  United States

Pennsylvania
      Valley Clinical Research Center, Easton,  Pennsylvania,  18045,  United States

Texas
      Pharmaceutical Research and Consulting, Inc., Dallas,  Texas,  75231,  United States

Wisconsin
      University of Wisconsin Medical School, Madison,  Wisconsin,  53792,  United States

      Allergy and Respiratory Care Center, Milwaukee,  Wisconsin,  53209,  United States

More Information

Study ID Numbers:  DAC-1003
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  December 19, 2001
ClinicalTrials.gov Identifier:  NCT00028288
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 21, 2008



Page Updated: June 1, 2005
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