search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dual Integrin Antagonist
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 24, 2002
Last Updated
June 15, 2017
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00048022
Brief Title
Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 25, 2002 (Actual)
Primary Completion Date
February 2, 2004 (Actual)
Study Completion Date
February 2, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dual Integrin Antagonist

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1690
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Louisville
State/Province
Colorado
ZIP/Postal Code
80027
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02745
Country
United States
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
City
Forked River
State/Province
New Jersey
ZIP/Postal Code
08731
Country
United States
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
City
Farmingdale
State/Province
New York
ZIP/Postal Code
11735
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19115
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-9988
Country
United States
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs