Overview

A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Criteria
Inclusion Criteria:

- Confirmed diagnosis of asthma for at least 6 months

- Short-acting beta-agonist use greater than or equal to 5 times in the 2 weeks prior to
screening

- Healthy on the basis of physical examination, medical history, vital signs, and 12
lead ECG performed at screening

- Having adequate laboratory values

- No history of/active or latent tuberculosis

- Agree to use protocol defined contraceptive methods

Exclusion Criteria:

- History of life-threatening asthma attack requiring hospitalization for asthma within
5 years of screening, or emergency department treatment of asthma within the last
month

- Moderate or severe renal insufficiency

- Cigarette smoking within the last year - Viral or bacterial vaccination within the
last month (eg, FluMist)

- Human Immunodeficiency Virus (HIV) or Hepatitis B or C positive