Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

NCT ID: NCT00024544

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2003-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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anti-IL-4 monoclonal antibody (pascolizumab)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Facet Biotech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Allergy Research Foundation

Los Angeles, California, United States

Site Status

Southern California Research

Mission Viejo, California, United States

Site Status

Clinical Trials of Orange Cnty., Inc.

Orange, California, United States

Site Status

Allergy Associates Medical Group, Inc.

San Diego, California, United States

Site Status

Allergy and Asthma Associates Santa Clara Valley Research Center

San Jose, California, United States

Site Status

Bensch Research Associates

Stockton, California, United States

Site Status

National Jewish Medical and Research Center

Denver, Colorado, United States

Site Status

ICSL Clinical Studies

Normal, Illinois, United States

Site Status

Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

New England Clinical Studies

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

The Clinical Research Center, LLC

St Louis, Missouri, United States

Site Status

Center for Allergy, Asthma and Immunology, Creighton University

Omaha, Nebraska, United States

Site Status

Princeton Center for Clinical Research

Princeton, New Jersey, United States

Site Status

Allergy, Asthma, and Dermatology Research Center, LLC

Lake Oswego, Oregon, United States

Site Status

Valley Clinical Research Center

Easton, Pennsylvania, United States

Site Status

Clinical Trials North Houston

Houston, Texas, United States

Site Status

University of Wisconsin Medical School

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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683-803

Identifier Type: -

Identifier Source: org_study_id

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