Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

March 6, 2012 updated by: Facet Biotech

A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Allergy Research Foundation
      • Mission Viejo, California, United States, 92691
        • Southern California Research
      • Orange, California, United States, 92868
        • Clinical Trials of Orange Cnty., Inc.
      • San Diego, California, United States, 92120
        • Allergy Associates Medical Group, Inc.
      • San Jose, California, United States, 95117
        • Allergy and Asthma Associates Santa Clara Valley Research Center
      • Stockton, California, United States, 95207
        • Bensch Research Associates
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Illinois
      • Normal, Illinois, United States, 61761
        • ICSL Clinical Studies
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
      • N. Dartmouth, Massachusetts, United States, 02747
        • New England Clinical Studies
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Clinical Research Institute
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • The Clinical Research Center, LLC
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Center for Allergy, Asthma and Immunology, Creighton University
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Center for Clinical Research
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Allergy, Asthma, and Dermatology Research Center, LLC
    • Pennsylvania
      • Easton, Pennsylvania, United States, 18045
        • Valley Clinical Research Center
    • Texas
      • Houston, Texas, United States, 77090
        • Clinical Trials North Houston
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Facet Biotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

September 19, 2001

First Submitted That Met QC Criteria

September 19, 2001

First Posted (Estimate)

September 20, 2001

Study Record Updates

Last Update Posted (Estimate)

March 7, 2012

Last Update Submitted That Met QC Criteria

March 6, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 683-803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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