Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00946569 | A Study of the Safety and Effectiveness of JNJ-39758979 in the Treatment of Adults With Persistent Asthma | PHASE2 | COMPLETED | 116 | — | — | Aug 1, 2009 | Sep 1, 2010 | Apr 29, 2014 | 24 | United States, Canada +2 |
FEV1 will be measured by using spirometry test. Spirometry is used to measure lung function, specifically the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Lung volumes will be measured according to the body temperature, pressure, and saturated standard convention using the spirometer. Pre-bronchodilator spirometry will be performed in the absence of albuterol/salbutamol or at least 6 hours after the last dose of albuterol/salbutamol.
| Arm | Type | Description |
|---|---|---|
| Treatment A (JNJ39758979) | EXPERIMENTAL | Participants will receive JNJ39758979 300mg once daily for 12 weeks. |
| Treatment B (Placebo) | PLACEBO_COMPARATOR | Participants will receive matching placebo once daily for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ39758979 | DRUG | Participants will receive capsule-shaped tablet of JNJ39758979 300mg once daily orally for 12 weeks. |
| Placebo | DRUG | Participants will receive matching placebo once daily orally for 12 weeks. |
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 ...