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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Drug: JNJ39758979

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00946569

39758979ASH2001 (Other Identifier)

CR016423

Details and patient eligibility

About

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.

Full description

This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), parallel group (each group of participants will be treated at the same time), exploratory study (JNJ-39758979 is introduced in participants with asthma for the first time). This study consists of 4 phases: screening phase (4 weeks prior to the start of the run-in period), placebo run-in phase (2 weeks prior to the start of treatment phase), double-blind treatment phase (12 weeks), and posttreatment phase (5 weeks). Approximately 100 participants will be randomly allocated to 1 of 2 treatment groups: Treatment A (participants will receive JNJ-39758979 once daily) and treatment B (participants will receive placebo once daily). Safety will be evaluated by assessment of adverse events, clinical laboratory tests, vital signs, physical examination, and 12-lead electrocardiogram. Total study duration for each participant will be approximately 23 weeks.

Enrollment

116 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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