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Study of Daclizumab in Patients With Chronic, Persistent Asthma

NCT ID: NCT00028288

Last Updated: 2012-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2003-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Daclizumab

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Facet Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Research Associates

Long Beach, California, United States

Site Status

Southern California Research

Mission Viejo, California, United States

Site Status

Institute of Health Care Assessment, Inc.

San Diego, California, United States

Site Status

Bensch Research Associates

Stockton, California, United States

Site Status

National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

Clinical Reserch Centers of Colorado

Denver, Colorado, United States

Site Status

Florida Center for Allergy and Asthma Reserch

Miami, Florida, United States

Site Status

Rx Research

Woodstock, Georgia, United States

Site Status

ICSL Clinical Studies

Bloomington, Illinois, United States

Site Status

Asthma and Allergy Center of Chicago, S.C.

River Forest, Illinois, United States

Site Status

New England Clinical Studies

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Princeton Center for Clinical Research

Princeton, New Jersey, United States

Site Status

Allergy, Asthma, and Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

Site Status

Valley Clinical Research Center

Easton, Pennsylvania, United States

Site Status

Pharmaceutical Research and Consulting, Inc.

Dallas, Texas, United States

Site Status

University of Wisconsin Medical School

Madison, Wisconsin, United States

Site Status

Allergy and Respiratory Care Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Busse WW, Israel E, Nelson HS, Baker JW, Charous BL, Young DY, Vexler V, Shames RS; Daclizumab Asthma Study Group. Daclizumab improves asthma control in patients with moderate to severe persistent asthma: a randomized, controlled trial. Am J Respir Crit Care Med. 2008 Nov 15;178(10):1002-8. doi: 10.1164/rccm.200708-1200OC. Epub 2008 Sep 11.

Reference Type DERIVED
PMID: 18787222 (View on PubMed)

Other Identifiers

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DAC-1003

Identifier Type: -

Identifier Source: org_study_id

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