Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
1 other identifier
interventional
N/A
2 countries
60
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2002
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2002
CompletedFirst Posted
Study publicly available on registry
October 25, 2002
CompletedStudy Start
First participant enrolled
October 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2004
CompletedJune 19, 2017
February 1, 2017
1.3 years
October 24, 2002
June 15, 2017
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Huntington Beach, California, 92647, United States
Unknown Facility
Los Angeles, California, 90025, United States
Unknown Facility
Los Angeles, California, 90095-1690, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Jose, California, 95128, United States
Unknown Facility
Walnut Creek, California, 94598, United States
Unknown Facility
Boulder, Colorado, 80304, United States
Unknown Facility
Denver, Colorado, 80206, United States
Unknown Facility
Louisville, Colorado, 80027, United States
Unknown Facility
Sarasota, Florida, 34233, United States
Unknown Facility
Tallahassee, Florida, 32308, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Tampa, Florida, 33609, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Normal, Illinois, 61761, United States
Unknown Facility
Indianapolis, Indiana, 46208, United States
Unknown Facility
Iowa City, Iowa, 52240, United States
Unknown Facility
Lenexa, Kansas, 66219, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
North Dartmouth, Massachusetts, 02745, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
Unknown Facility
Missoula, Montana, 59804, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89104, United States
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Forked River, New Jersey, 08731, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Farmingdale, New York, 11735, United States
Unknown Facility
Rochester, New York, 14618, United States
Unknown Facility
Rockville Centre, New York, 11570, United States
Unknown Facility
Asheville, North Carolina, 28801, United States
Unknown Facility
Canton, Ohio, 44718, United States
Unknown Facility
Cincinnati, Ohio, 45231, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Eugene, Oregon, 97401, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97213, United States
Unknown Facility
Philadelphia, Pennsylvania, 19115, United States
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Philadelphia, Pennsylvania, 19140, United States
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Upland, Pennsylvania, 19013, United States
Unknown Facility
Providence, Rhode Island, 02906, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Austin, Texas, 78750, United States
Unknown Facility
Dallas, Texas, 75230, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Sugar Land, Texas, 77478, United States
Unknown Facility
Murray, Utah, 84107, United States
Unknown Facility
South Burlington, Vermont, 05403, United States
Unknown Facility
Abingdon, Virginia, 24210, United States
Unknown Facility
Bellingham, Washington, 98225, United States
Unknown Facility
Kirkland, Washington, 98034, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Tacoma, Washington, 98405, United States
Unknown Facility
Morgantown, West Virginia, 26505, United States
Unknown Facility
Madison, Wisconsin, 53792-9988, United States
Unknown Facility
Ponce, 00732, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2002
First Posted
October 25, 2002
Study Start
October 25, 2002
Primary Completion
February 2, 2004
Study Completion
February 2, 2004
Last Updated
June 19, 2017
Record last verified: 2017-02