A Phase 2 interventional study of JNJ-18054478 and sham comparator in Asthma, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Terminated at 36 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-18.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Phase 2, Interventional, and Treatment
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.
Asthma is one of the most common chronic diseases worldwide. This is a randomized (study medication assigned by chance), double-blind study (neither the physician or the patient knows which drug they are receiving, active or placebo) to Investigate the effectiveness and safety of 12 weeks of dosing with JNJ-18054478 (300 mg taken orally once daily) compared with placebo in patients with persistent asthma. The hypothesis is that the study drug will be more effective in treatment of asthma than placebo as measured by the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) after 12 weeks of therapy, without any significant adverse events. Safety evaluations will include, monitoring for adverse reactions, clinical laboratory tests of blood and urine, ECGs to monitor the cardiovascular system, vital signs and physical examinations. Patients will take three capsules (100 mg) of JNJ-18054478 orally once daily for 12 weeks or placebo for the same period.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 26 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 458 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
sham comparator 3(100 mg) tablets once daily for 12 weeks
Drug: sham comparator
JNJ-18054478 3(100 mg) tablets once daily for 12 weeks
Drug: JNJ-18054478
3(100 mg) tablets once daily for 12 weeks
3(100 mg) tablets once daily for 12 weeks
The percent change from the beginning of the study in Forced Expiratory Volume in one Second (FEV1) after 12 weeks on study drug.
Time frame: 12 weeks
The change in FEV1 after 1, 2, 4, 6, 8 and 10 weeks therapy. The change in symptoms and use of asthma rescue medication. The number of asthma attacks compared to placebo. The safety, tolerability, and blood and urine levels of JNJ-18054478
Time frame: 12 weeks
This study is terminated, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.