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

Completed · Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00048022

Run by

Hoffmann-La Roche

Starts

2002-10-25

Expected to finish

2004-02-02

Last updated by the study team

2017-06-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Jose, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Boulder, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Louisville, Colorado, United States
• Study site — Sarasota, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Normal, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lenexa, Kansas, United States
• Study site — Metairie, Louisiana, United States
• Study site — North Dartmouth, Massachusetts, United States
• Study site — Huntington Beach, California, United States

Full record on ClinicalTrials.gov

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