Clinical trial NCT00048022: Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Boulder
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Louisville
country: United States
state: Colorado
city: Sarasota
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Normal
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Lenexa
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: North Dartmouth
country: United States
state: Massachusetts
city: Ypsilanti
country: United States
state: Michigan
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Forked River
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Farmingdale
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rockville Centre
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: South Burlington
country: United States
state: Vermont
city: Abingdon
country: United States
state: Virginia
city: Bellingham
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
city: Ponce
country: Puerto Rico
Study officials:
References: