Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00024544
• Other study ID #: 683-803
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2001
• Last updated: March 6, 2012
• Start date: August 2001
• Est. completion date: February 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2003
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• anti-IL-4 monoclonal antibody (pascolizumab)

Locations

Country	Name	City	State
United States	Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital	Boston	Massachusetts
United States	National Jewish Medical and Research Center	Denver	Colorado
United States	Valley Clinical Research Center	Easton	Pennsylvania
United States	Clinical Trials North Houston	Houston	Texas
United States	Allergy, Asthma, and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Allergy Research Foundation	Los Angeles	California
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	New England Clinical Studies	N. Dartmouth	Massachusetts
United States	ICSL Clinical Studies	Normal	Illinois
United States	Center for Allergy, Asthma and Immunology, Creighton University	Omaha	Nebraska
United States	Clinical Trials of Orange Cnty., Inc.	Orange	California
United States	Princeton Center for Clinical Research	Princeton	New Jersey
United States	Allergy Associates Medical Group, Inc.	San Diego	California
United States	Allergy and Asthma Associates Santa Clara Valley Research Center	San Jose	California
United States	The Clinical Research Center, LLC	St. Louis	Missouri
United States	Bensch Research Associates	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
Facet Biotech

Country where clinical trial is conducted

United States,