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Study of Daclizumab in Patients With Chronic, Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00028288
Recruitment Status : Completed
First Posted : December 20, 2001
Last Update Posted : March 13, 2012
Sponsor:
Information provided by (Responsible Party):
Facet Biotech

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Daclizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
Study Start Date : September 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Daclizumab





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028288


Locations
Show Show 18 study locations
Sponsors and Collaborators
Facet Biotech
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00028288    
Other Study ID Numbers: DAC-1003
First Posted: December 20, 2001    Key Record Dates
Last Update Posted: March 13, 2012
Last Verified: March 2012
Keywords provided by Facet Biotech:
Asthma
Daclizumab
anti-Tac monoclonal antibody
anti-IL-2
Zenapax
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs