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| ID | Type | Description | Link |
|---|---|---|---|
| 39758979ASH2002 | Other Identifier | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | |
| 2011-003852-37 | EudraCT Number |
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Study was withdrawn due to 2 cases of agranulocytosis in a different clinical trial with this same drug.
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The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-39758979 compared with placebo in patients with uncontrolled asthma despite current treatment with inhaled corticosteroids and/or long-acting beta 2-agonist (LABA) and/or montelukast for at least 4 weeks.
This is a two-part study; each part of the study (Part 1 and Part 2) will be approximately 34 weeks in duration including a 4-week screening phase, a 24-week placebo-controlled treatment phase and a six-week follow-up phase. In Part 1, patients will be randomly assigned to receive placebo or JNJ-39758979 300 mg once daily through Week 24. In Part 2, patients will be randomly assigned to 1 of 4 treatment groups to receive treatment with placebo, 30 mg, 100 mg, or 300 mg of JNJ-39758979 once daily through Week 24. Safety assessments and evaluations to determine the efficacy of JNJ-39758979 to reduce the signs and symptoms of asthma will be performed both on a daily basis via electronic diary and at study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| JNJ-39758979 30 mg/d | Experimental |
| |
| JNJ-39758979 100 mg/d | Experimental |
| |
| JNJ-39758979 300 mg/d | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change from baseline in percent-predicted prebronchodilator forced expiratory volume (FEV1) at Week 16 in Part 1 and in Part 2. | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Asthma Control Questionnaire (ACQ) at Week 16 in Part 1 and Part 2 | Baseline, Week 16 | |
| Change from baseline in postbronchodilator percent-predicted forced expiratory volume in 1 second (FEV1) at Week 16 in Part 1 and Part 2 | Baseline, Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| JNJ-39758979 30 mg/d | Drug | Unit = mg, number = 30, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2 |
|
| JNJ-39758979 100 mg/d | Drug | Unit = mg, number = 100, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2 |
|
| JNJ-39758979 300 mg/d | Drug | Unit = mg, number = 300, form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2 |
|
| Change from baseline in daytime asthma diary symptom score at Week 16 in Part 1 and Part 2 | Baseline, Week 16 |
| Change from baseline in nighttime asthma diary symptom score at Week 16 in Part 1 and Part 2 | Baseline, Week 16 |
| Change from baseline in average rescue medication use at Week 16 in Part 1 and Part 2 | Baseline, Week 16 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |