Clinical trial NCT00048009: Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids
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 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palmdale
country: United States
state: California
city: San Diego
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: Denver
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Louisville
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
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: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Normal
country: United States
state: Illinois
city: River Forest
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: Minneapolis
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Cherry Hill
country: United States
state: New Jersey
city: Princeton
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: Elizabeth City
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Easton
country: United States
state: Pennsylvania
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: 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: El Paso
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Sydney
country: Australia
city: Woodville
country: Australia
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec City
country: Canada
state: Quebec
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Merida
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico, Df
country: Mexico
city: Mexico
country: Mexico
city: Monterrey
country: Mexico
city: Monterrey
country: Mexico
city: Puebla
country: Mexico
city: Ponce
country: Puerto Rico
Study officials:
References: