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NCT00028288 Clinical Trial

Study of Daclizumab in Patients With Chronic, Persistent Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00028288
Other study ID # DAC-1003
Secondary ID
Status Completed
Phase Phase 2
First received December 19, 2001
Last updated March 9, 2012
Start date September 2001
Est. completion date December 2003

Study information
Verified date March 2012
Source Facet Biotech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 2003
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Daclizumab

Locations
Country Name City State
United States ICSL Clinical Studies Bloomington Illinois
United States Pharmaceutical Research and Consulting, Inc. Dallas Texas
United States Clinical Reserch Centers of Colorado Denver Colorado
United States National Jewish Medical and Research Center Denver Colorado
United States Valley Clinical Research Center Easton Pennsylvania
United States Allergy, Asthma, and Dermatology Research Center, LLC Lake Oswego Oregon
United States Medical Research Associates Long Beach California
United States University of Wisconsin Medical School Madison Wisconsin
United States Florida Center for Allergy and Asthma Reserch Miami Florida
United States Allergy and Respiratory Care Center Milwaukee Wisconsin
United States Clinical Research Institute Minneapolis Minnesota
United States Southern California Research Mission Viejo California
United States New England Clinical Studies North Dartmouth Massachusetts
United States Princeton Center for Clinical Research Princeton New Jersey
United States Asthma and Allergy Center of Chicago, S.C. River Forest Illinois
United States Institute of Health Care Assessment, Inc. San Diego California
United States Bensch Research Associates Stockton California
United States Rx Research Woodstock Georgia

Sponsors (1)
Lead Sponsor Collaborator
Facet Biotech

Country where clinical trial is conducted

United States, 

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