AsthmaPhase 2NCT00028288
Study of Daclizumab in Patients With Chronic, Persistent Asthma
A Phase 2 study testing Daclizumab in people with Asthma, run by Facet Biotech at 18 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Daclizumab
- How many people
- 120 participants
- Where
- 18 sitesUnited States
- Study dates
- Sep 2001to Dec 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
ICSL Clinical Studies
Bloomington, Illinois, 61704
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231
National Jewish Medical and Research Center
Denver, Colorado, 80206
Clinical Reserch Centers of Colorado
Denver, Colorado, 80230
Valley Clinical Research Center
Easton, Pennsylvania, 18045
Allergy, Asthma, and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035
Medical Research Associates
Long Beach, California, 90806
University of Wisconsin Medical School
Madison, Wisconsin, 53792
Florida Center for Allergy and Asthma Reserch
Miami, Florida, 33176
Allergy and Respiratory Care Center
Milwaukee, Wisconsin, 53209
Clinical Research Institute
Minneapolis, Minnesota, 55402
Southern California Research
Mission Viejo, California, 92691
New England Clinical Studies
North Dartmouth, Massachusetts, 02747
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, 60305
Institute of Health Care Assessment, Inc.
San Diego, California, 92120
Bensch Research Associates
Stockton, California, 95207
Rx Research
Woodstock, Georgia, 30188
About this study
Official title: 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.
- Conditions
- Asthma
- Being tested
- Daclizumab
- Keywords
- Asthma, Daclizumab, anti-Tac monoclonal antibody, anti-IL-2, Zenapax
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaclizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2001 (estimated)
- Study startSep 2001
- Primary completionDec 2003
- Study completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Facet Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028288
- Sponsor's protocol ID
- DAC-1003
- Status last verified
- Mar 2012
- First submitted
- 19 Dec 2001
- Last updated
- 13 Mar 2012
- Results posted
- No
Publications
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.
PubMed 18787222
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
- ClinicalTrials.gov ID
- NCT00028288
- Acronym / sponsor ID
- DAC-1003
- Conditions
- Asthma
- Keywords
- Asthma, Daclizumab, anti-Tac monoclonal antibody, anti-IL-2, Zenapax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Facet BiotechIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 20 Dec 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daclizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
- Derived from this study: PubMed 18787222Busse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daclizumab in people with Asthma, run by Facet Biotech at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00028288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.