Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

June 15, 2017 updated by: Hoffmann-La Roche
The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Puerto Rico
      • Ponce, Puerto Rico, 00732
  • United States
    • California
      • Huntington Beach, California, United States, 92647
      • Los Angeles, California, United States, 90025
      • Los Angeles, California, United States, 90095-1690
      • Mission Viejo, California, United States, 92691
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92120
      • San Jose, California, United States, 95128
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Boulder, Colorado, United States, 80304
      • Denver, Colorado, United States, 80206
      • Louisville, Colorado, United States, 80027
    • Florida
      • Sarasota, Florida, United States, 34233
      • 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
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
      • Normal, Illinois, United States, 61761
    • 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
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
    • Montana
      • Missoula, Montana, United States, 59804
    • Nebraska
      • Omaha, Nebraska, United States, 68114
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New Jersey
      • Forked River, New Jersey, United States, 08731
      • 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
      • Asheville, North Carolina, United States, 28801
    • Ohio
      • Canton, Ohio, United States, 44718
      • Cincinnati, Ohio, United States, 45231
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
    • Oregon
      • Eugene, Oregon, United States, 97401
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • 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
    • Texas
      • Austin, Texas, United States, 78750
      • Dallas, Texas, United States, 75231
      • Dallas, Texas, United States, 75230
      • Sugar Land, Texas, United States, 77478
    • Utah
      • Murray, Utah, United States, 84107
    • Vermont
      • South Burlington, Vermont, United States, 05403
    • Virginia
      • Abingdon, Virginia, United States, 24210
    • Washington
      • Bellingham, Washington, United States, 98225
      • Kirkland, Washington, United States, 98034
      • Seattle, Washington, United States, 98105
      • Tacoma, Washington, United States, 98405
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-9988

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:

  • Persistent asthma for more than 1 year
  • Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months
  • In good health as 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 1 month after discontinuing therapy

Exclusion Criteria:

  • Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study
  • Undergoing allergy shots unless on a stable maintenance dose for 3 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 1 month of the start of the study
  • Current tobacco usage
  • 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

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

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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 (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 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA16630

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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