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

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.