Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids

The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to be used in future studies, assess the efficacy and safety, and the anti-inflammatory action of the test drug in the treatment of asthmatic patients who are not currently receiving chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical research sites in the US, Mexico, and Canada. Study participants will have a number of visits to a research site over approximately a 4-month period.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Dual Integrin Antagonist

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
  • Brisbane, Australia, 4102
  • Melbourne, Australia, 3050
  • Perth, Australia, 6009
  • Sydney, Australia, 2139
  • Woodville, Australia, 5011
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
    • Toronto, Ontario, Canada, M5S 2A5
    • Toronto, Ontario, Canada, M6H 3M2
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
    • Quebec City, Quebec, Canada, O1V 4G5
• Mexico
  • Chihuahua, Mexico, 31000
  • Guadalajara, Mexico, 44600
  • Merida, Mexico
  • Mexico, Mexico, 14080
  • Mexico City, Mexico, 06700
  • Mexico City, Mexico, 14050
  • Mexico, Df, Mexico, 06720
  • Monterrey, Mexico, 64000
  • Monterrey, Mexico, 64710
  • Puebla, Mexico, 72000
• Puerto Rico
  • Ponce, Puerto Rico, 00732
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
  • California
    • Huntington Beach, California, United States, 92647
    • Long Beach, California, United States, 90806
    • Los Angeles, California, United States, 90025
    • Los Angeles, California, United States, 90095-1690
    • Palmdale, California, United States, 93551
    • San Diego, California, United States, 92103
    • San Diego, California, United States, 92123
    • San Diego, California, United States, 92120
    • San Jose, California, United States, 95128
    • Walnut Creek, California, United States, 94598
  • Colorado
    • Denver, Colorado, United States, 80206
    • Denver, Colorado, United States, 80230
    • Louisville, Colorado, United States, 80027
    • Wheat Ridge, Colorado, United States, 80033
  • Connecticut
    • Hartford, Connecticut, United States, 06106
  • Florida
    • Tallahassee, Florida, United States, 32308
    • Tamarac, Florida, United States, 33321
    • Tampa, Florida, United States, 33613
    • Tampa, Florida, United States, 33609
  • Georgia
    • Atlanta, Georgia, United States, 30309
    • Savannah, Georgia, United States, 31406
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
    • Normal, Illinois, United States, 61761
    • River Forest, Illinois, United States, 60305
  • Indiana
    • Indianapolis, Indiana, United States, 46208
  • Iowa
    • Iowa City, Iowa, United States, 52240
  • Kansas
    • Lenexa, Kansas, United States, 66219
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02745
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
  • Missouri
    • Saint Louis, Missouri, United States, 63141
  • Montana
    • Missoula, Montana, United States, 59804
  • Nebraska
    • Omaha, Nebraska, United States, 68114
  • Nevada
    • Las Vegas, Nevada, United States, 89104
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
    • Princeton, New Jersey, United States, 08540
    • Teaneck, New Jersey, United States, 07666
  • New York
    • Farmingdale, New York, United States, 11735
    • Rochester, New York, United States, 14618
    • Rockville Centre, New York, United States, 11570
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
  • Ohio
    • Canton, Ohio, United States, 44718
    • Cincinnati, Ohio, United States, 45231
  • Oregon
    • Medford, Oregon, United States, 97504
    • Portland, Oregon, United States, 97213
  • Pennsylvania
    • Easton, Pennsylvania, United States, 18045
    • Philadelphia, Pennsylvania, United States, 19140
    • Philadelphia, Pennsylvania, United States, 19115
    • Upland, Pennsylvania, United States, 19013
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
  • South Carolina
    • Charleston, South Carolina, United States, 29425
    • Charleston, South Carolina, United States, 29407
  • Texas
    • Austin, Texas, United States, 78750
    • Dallas, Texas, United States, 75231
    • Dallas, Texas, United States, 75240
    • El Paso, Texas, United States, 79925
    • San Antonio, Texas, United States, 78229
    • Sugar Land, Texas, United States, 77478
  • Utah
    • Murray, Utah, United States, 84107
  • Washington
    • Kirkland, Washington, United States, 98034
    • Seattle, Washington, United States, 98105
    • Spokane, Washington, United States, 99202
    • Tacoma, Washington, United States, 98405
    • Wenatchee, Washington, United States, 98801
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-9988
    • Milwaukee, Wisconsin, United States, 53209

Participation Criteria

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:

• Persistent asthma for more than one year
• Current treatment for asthma with short acting inhaled beta 2 agonists (such as albuterol) only
• In good health ad demonstrated by medical history and physical exam
• Negative urine pregnancy test
• Commitment to use two forms of effective contraception simultaneously throughout the study duration and for one month after discontinuing therapy

Exclusion Criteria:

• Asthma necessitating treatment with inhaled corticosteroids for at least one month before the start of the study
• History of severe asthma necessitating the use of oral/injectable corticosteroids within the last 2 months and/and or two bursts in the last year
• Undergoing allergy shots unless on a stable maintenance dose for three months before the start of the study
• History of chronic pulmonary diseases other than asthma
• Treatment of conditions other than asthma with oral corticosteroids within one month of the start of the study
• Current tobacco use
• Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked)
• History or evidence of drug or alcohol abuse
• Diagnosis or evidence of an infectious illness within one month of Visit 1
• Clinically significant diseases as assessed by the study doctor
• Participation in another clinical study with an experimental drug within one month of start of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2002
• Primary Completion (Actual): February 2, 2004
• Study Completion (Actual): February 2, 2004

Study Registration Dates

• First Submitted: October 24, 2002
• First Submitted That Met QC Criteria: October 24, 2002
• First Posted (Estimate): October 25, 2002

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BA16631