Clinical trial NCT00024544: Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
anti-IL-4 monoclonal antibody
pascolizumab
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2001-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

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