Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
This study has been completed.
Sponsor:
Facet Biotech
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00024544
First received: September 19, 2001
Last updated: March 6, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: anti-IL-4 monoclonal antibody (pascolizumab) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma |
Resource links provided by NLM:
Further study details as provided by Facet Biotech:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least a 6-month history of asthma
- No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment
Exclusion Criteria:
- Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00024544
Locations
| United States, California | |
| Allergy Research Foundation | |
| Los Angeles, California, United States, 90025 | |
| Southern California Research | |
| Mission Viejo, California, United States, 92691 | |
| Clinical Trials of Orange Cnty., Inc. | |
| Orange, California, United States, 92868 | |
| Allergy Associates Medical Group, Inc. | |
| San Diego, California, United States, 92120 | |
| Allergy and Asthma Associates Santa Clara Valley Research Center | |
| San Jose, California, United States, 95117 | |
| Bensch Research Associates | |
| Stockton, California, United States, 95207 | |
| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Illinois | |
| ICSL Clinical Studies | |
| Normal, Illinois, United States, 61761 | |
| United States, Massachusetts | |
| Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| New England Clinical Studies | |
| N. Dartmouth, Massachusetts, United States, 02747 | |
| United States, Minnesota | |
| Clinical Research Institute | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Missouri | |
| The Clinical Research Center, LLC | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Center for Allergy, Asthma and Immunology, Creighton University | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Princeton Center for Clinical Research | |
| Princeton, New Jersey, United States, 08540 | |
| United States, Oregon | |
| Allergy, Asthma, and Dermatology Research Center, LLC | |
| Lake Oswego, Oregon, United States, 97035 | |
| United States, Pennsylvania | |
| Valley Clinical Research Center | |
| Easton, Pennsylvania, United States, 18045 | |
| United States, Texas | |
| Clinical Trials North Houston | |
| Houston, Texas, United States, 77090 | |
| United States, Wisconsin | |
| University of Wisconsin Medical School | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
Facet Biotech
More Information
No publications provided
| Responsible Party: | Facet Biotech |
| ClinicalTrials.gov Identifier: | NCT00024544 History of Changes |
| Other Study ID Numbers: | 683-803 |
| Study First Received: | September 19, 2001 |
| Last Updated: | March 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Facet Biotech:
|
asthma anti-IL-4 monoclonal antibody pascolizumab |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013