Effectiveness and Safety Study for JNJ-18054478 in Asthma Patients.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to assess the effectiveness of JNJ-18054478 measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy in patients with persistent asthma.

Key facts

Study ID

NCT00530166

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

26

Starts

2007-07-01

Expected to finish

2008-07-01

Last updated by the study team

2014-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medically confirmed diagnosis of persistent asthma
• Able to demonstrate reversibility of at least 12% with albuterol inhalation
• Use of short-acting b-2 agonists for rescue >= 5 times within 2 weeks prior
• Able to produce an FEV1 between 45 and 85% of predicted
• Willing to perform study procedures for about 14 weeks.

You may not qualify if…

• Use of inhaled corticosteroids within 4 weeks
• Use of oral/parenteral corticosteroids within 8 weeks
• Use of long-acting beta-2 agonists or montelukast within 2 weeks
• History of life-threatening asthma attack within 3 months
• Female of child bearing potential.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Paramount, California, United States
• Study site — San Jose, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Chicago, Illinois, United States
• Study site — Normal, Illinois, United States
• Study site — River Forest, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — North Dartmouth, Massachusetts, United States
• Study site — Plymouth, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Skillman, New Jersey, United States
• Study site — North Syracuse, New York, United States
• Study site — Rochester, New York, United States
• Study site — Canton, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Medford, Oregon, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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